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Abstract of dissertation entitled
“An evidenced-based guideline on cold application prior to the removal of chest
tubes to reduce pain in cardiothoracic surgical patients”
Submitted by
Yim Tin Chee
For the degree of Master of Nursing at the University of Hong Kong
in July 2015
Chest tubes are commonly inserted during cardiothoracic surgery (CTS) in order
to drain air and fluid out from the pleural cavity. Chest tube removal (CTR) will be
performed by the physician if the drainage amount is adequate. Nevertheless, CTS
patients have reported unpleasant painful experiences during CTR. They are highly
susceptible to postoperative complications and thus delay their recovery processes and
increase the medical costs for these uncontrolled pains. Both CTS patients and the
medical institution can share the benefits if an effective and evidence based
intervention can be introduced.
The aims of this dissertation are to evaluate the current evidences of applying
cold application prior to CTR to reduce pain in CTS patients, to develop a
standardized and evidence based protocol for nurses by using pharmacological and
non-pharmacological methods to manage pain suffered by CTS patients during CTR,
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to assess its transferability and feasibility and discuss the implementation designs in
CTS units in Hong Kong. Finally, an evaluation plan will be developed to evaluate the
clinical outcomes.
There were seven articles included which related to the use of cold application to
relieve pain for CTS patients during CTR. Checklist designed by the Scottish
Intercollegiate Guidelines Network (SIGN) was used to evaluate the methodological
quality of the selected articles. Six articles were rated as acceptable in methodological
quality which successfully demonstrated better pain relieving effect in cold
application group when compared with control group immediately and certain period
after CTR.
A nurse driven evidence based guideline has been created after literature review.
The implementation potential of the guideline in local CTS units has been examined.
A working group consists of administrators, experienced and frontline staffs will be
responsible to guide the programme implementation. Feedbacks for the guideline are
collected via communication between the group members and other frontline staffs.
The feasibility of the programme will be determined based on the results of the pilot
study. The patient’s outcomes, healthcare provider outcomes and system outcomes
will be monitored by the working group annually to determine the worthiness of the
programme.
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An evidenced-based guideline on cold application prior to the
removal of chest tubes to reduce pain in cardiothoracic surgical
patients
by
Yim Tin Chee
BN, RN
A thesis submitted in partial fulfillment of the requirements for the Degree of
Master of Nursing at the University of Hong Kong.
July 2015
4
Declaration
I declare that this thesis represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a thesis,
dissertation or report submitted to this University or to any other institution for a
degree, diploma or other qualifications.
Signed: Yim Tin Chee
5
Acknowledgements
I would like to express my sincere gratitude to my dissertation supervisor, Dr
Janet Wong (Assistant Professor), who has provided invaluable guidance,
encouragement and expert opinions throughout the 2 years dissertation preparations.
Beside, I would also like to thank my dear classmates of the Master of Nursing
programme (2015) and hospital colleagues, who have supported and given me
encouragement throughout the study.
Finally, I would like to express my deepest gratitude to my family for their
greatest support during my 2 years study. Without their support, I cannot concentrate
to complete these 2 years study.
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Content Page
Dissertation abstract P.1
Declaration P.4
Acknowledgements P.5
Chapter 1: Introduction
1.1: Background of the study issue P.10
1.2: Affirming need of the study issue P.11
1.3: Objectives and significance P.13
Chapter 2: Critical appraisal
2.1: Search and appraisal strategies
2.1.1: Databases searching P.15
2.1.2: Inclusion and exclusion criteria P.15
2.1.3: Data extraction P.15
2.1.4: Appraisal strategies P.16
2.2: Results
2.2.1: Date of search and search history P.17
2.2.2: Study characteristics P.17
7
2.2.3: Methodological Quality P.18
2.3: Summary and synthesis
2.3.1: Summary of results P.21
2.3.2: Synthesis of results P.24
2.3.3: Conclusion P.29
Chapter 3: Implementation potential and clinical guideline
3.1: Transferability of findings
3.1.1: Target setting and population P.31
3.1.2: Similarities and differences between local and literature settings P.32
3.1.3: Philosophy of care P.32
3.1.4: Periods for implementation and evaluation P.33
3.2: Feasibility of findings
3.2.1: Manpower and attitudes of the nurses P.33
3.2.2: Training sessions and environment P.34
3.2.3: Multi-discipline co-operations P.35
3.2.4: Tools for evaluation P.36
3.3: Costs and Benefits
3.3.1: Individual benefits and risks P.37
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3.3.2: Material costs of the institution P.39
3.3.3: Non-material costs of the institution P.40
3.4: Evidence-based practice guideline
3.4.1: Guideline title P.41
3.4.2: Objectives P.41
3.4.3: Target populations P.42
3.4.4: Evidence based recommendations P.42
Chapter 4: Implementation plan
4.1: Communication plan--- An overview
4.1.1: Stakeholders identification P.44
4.1.2: Forming a working group P.45
4.1.3: Roles of working group P.46
4.2: Pilot study plan
4.2.1: Patient’s recruitment P.49
4.2.2: Rundown testing P.49
4.2.3: Pilot study evaluations P.50
4.3: Evaluation plan
4.3.1: Patient outcomes P.51
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4.3.2: Healthcare provider outcomes P.52
4.3.3: Systems outcomes P.52
4.3.4: Data measurements and analysis P.53
4.3.4.1: Patients outcomes P.53
4.3.4.2: Healthcare provider outcomes P.55
4.3.4.3: System outcomes P.55
4.4: Basis for implementation P.55
Conclusion P.56
References P.56
Appendices P.62
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Chapter 1: Introduction
1.1: Background of the study issue
Chest tubes are commonly inserted during cardiothoracic surgeries (CTS), such
as coronary artery bypass grafting with or without heart valves repair and lobectomy
(Mitra, Nahid, Nouraddin & Eskandar, 2014; Sauls, 2002), in order to drain air and
fluid out from the pleural cavity (Demir & Khorsbid, 2010; Ertug & Ulker, 2011).
Chest tubes will be removed by the physicians when the drainage amount is adequate
(Gorji, Nesami, Ayyasi, Ghafari & Yazdani, 2014). Chest tube removal (CTR) is
described as a painful experience by the patients (Demir & Khorsbid, 2010; Sauls,
2002). Chest tube adheres to the endothelium of the pleural cavity. Pulling effort
during CTR will detach this adhesion causing sharp pain to the patients (Demir &
Khorshid, 2010).
In order to help relieve the pain suffered by these patients during CTR,
traditional pharmacological method such as acetaminophen and morphine are
prescribed to the patients by providing anti-inflammatory effect and directly acting on
central nervous system respectively (Mitra et al., 2014). For non-pharmacological
method, cold application was considered to be applied to these patients to reduce their
pain. Cold packs (silica gel) or ice bags are common materials used in cold
application (Kol, Erdogan, Karsh & Erbil, 2013). It was thought that cold application
11
could reduce the pain impulse transmission velocity and block the pain signal
transmission from the periphery pain receptors to the spinal cord (Yagiz, 2006, as
cited in Kol et al., 2013). However, the evidence of the effect of cold application
before CTR to reduce procedural pain in CTS patients is unclear.
1.2: Affirming need of the study issue
My working place is a surgical ward which involves postoperative CTS cases.
Around 17 chest tubes will be removed each month for these patients by official
statistics (NTWC, 2014). Usually, CTR are done by physicians at their convenient
time without noticing the responsible nurses prior the procedure. Therefore,
analgesics are given at the time of starting the procedure. There is not enough time for
the drugs to exert its therapeutic effects in reducing pain suffered by the patients
during the procedure. To conclude, preparations for CTR to the patients are hurried
and inadequate.
Majority of patients reported intense pain during CTR and moderate pain after
CTR even though analgesics (panadol or tramadol tablets) are given before and after
the procedure. Complications such as decrease in chest expansion, tachycardia and
myocardial infarction can be resulted if these unrelieved pain are neglected, especially
for the CTS patients (Gorji et al., 2014). Therefore, it is crucial and ethical for nurses
to have an accurate pain assessment, charting and management to the pain complains
12
by the patients (Demir & Khorshid, 2010; Mitra et al., 2014; Sauls, 2002).
To relieve these procedural pains in a better way, several potent drugs such as
midazolam and acetaminophen in intravenous form can be considered. However,
these drugs may create some cardiovascular side effects which are particularly
vulnerable for those CTS patients and the pain relieving effects by using drugs alone
are not efficacious (Gorji et al., 2014; Mitra et al., 2014). On the other hand,
non-pharmacological method such as cold application is being considered as an
alternative. Various studies had proven that cold application could help increase the
tolerance to pain and decrease the request for analgesics for the orthopedic and
gynecologic surgical patients by decreasing the speed of pain impulse conduction and
producing anti-inflammatory effect (Demir & Khorshid, 2010; Sauls, 2002). When
compared with pharmacological methods, cold application does not introduce harmful
chemical substances to the body and does not produce unexpected physiological
effects to the patients (Ertug & Ulker, 2011). Another advantage for cold application
is that it is simple and easy to be applied by the nurses. Finally, silica gel packs or ice
bags are cheap in prices which can help decrease the cost in applying cold application
to the patients (Demir & Khorshid, 2010).
Although cold application has been shown to be helpful for various surgical
pains, no systematic reviews have been conducted to demonstrate the evidence to
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CTR procedural pain. Also, some contradictory results arose from previous studies
regarding to the control of CTR procedural pain in using cold application (Demir &
Khorshid, 2010). Therefore, the existing articles related to the effect of cold
application on CTR procedural pain are systematically reviewed by comparing the
methodologies applied during the studies in this translational research.
1.3: Objectives and Significance
The translational research question is listed below in PICO format:
1: Patient (P): CTS patients who are going to undergo CTR procedure.
2: Intervention group (I): CTS patients with cold application applied before CTR
procedure.
3: Comparison group (C): CTS patients without cold application applied before CTR
procedure.
4: Outcomes (O): Pain level perceived by the CTS patients immediately and 15
minutes after CTR procedure.
The objectives of this translational research:
1: To evaluate the current evidences of cold application on CTR pain control by
comparing methodology quality of various related studies.
2: To establish an evidence-based guideline for the nurses in implementing cold
application before CTR for the CTS patients.
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3: To assess the potential and possibility of transferring ‘cold application before CTR’
guideline to the CTS units among Hong Kong hospitals.
4: To evaluate the cost-effectiveness and the difficulties encountered by the nurses
when implementing ‘cold application before CTR’ guideline.
The significance of this study:
Pain is regarded as the fifth vital sign in assessing patients’ general condition
(Ertug & Ulker, 2011). If cold application is effective in controlling procedural pain
during CTR for the CTS patients, the chance of having respiratory and cardiovascular
complications can be reduced (Gorji et al., 2014). In addition, uncontrolled pain
suffered during CTR may increase the anxiety level being felt by the patients, poor
surgical outcomes may result (Demir & Khorshid, 2010). Finally, with an effective
pain management method provided by the nurses before CTR, patients will feel that
they are being cared and build a rapport relationship with their nurses, which can
enhance recovery.
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Chapter 2: Critical appraisal
2.1: Search and appraisal strategies
2.1.1: Databases searching
Two electronic data bases were used during the initial search, which were
Pubmed and CINAHL. The keywords used during the search were “cardiac patients”,
“thoracic surgery patients”, “cardiothoracic patients”, “cold application”,
“cryotherapy”, “chest tube removal”, “chest drain removal” and “pain”. After
keywords search, each article yielded from the initial search was reviewed by title,
abstract and full text respectively to assess for relevance. The reference list of each
article had also been reviewed to find out related articles. To enrich the findings,
Google scholar was used as a final resource for searching by using the same
keywords.
2.1.2: Inclusion and exclusion criteria
Inclusion and exclusion criteria were established during the search. The inclusion
criteria included adults (>18 years old), orientated to time, place and person, able to
rate pain level by using pain scores. The exclusion criteria included patients with
psychiatric diseases and hypersensitive to cold application.
2.1.3: Data extraction
After collecting the articles, data were extracted from each of them. The
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extracted items included bibliographic citation, study type, sample characteristics,
cold application and comparison groups’ implementation details, length of follow up,
outcome measurements and effect sizes of the study. These items were then elaborated
in a table as shown in Appendix 2.
2.1.4: Appraisal strategies
The quality of the studies in terms of methodology was rated according to the
guidelines listed on the methodology checklist by the Scottish Intercollegiate
Guidelines Network (SIGN) (Scottish Intercollegiate Guidelines Network, 2014). This
checklist consists of two parts, which are internal validity and overall assessment of
the study. Main items in the internal validity part included the appropriateness of the
study question, the randomization and concealment methods used when assigning
patients into different groups, the use of blinding methods, the demographic
differences among the patients before the study, the reliability and validity of the tools
used for measuring outcomes, the drop out rate, the intention-to-treat approach in
analyzing the effects of drop out patients and the comparison of study results among
various study sites if any. For the overall assessment part, the effort of diminishing
biases by the researchers, the statistical power of the sample, the applicability of the
intervention and generalizability of the study results are assessed. These items will be
evaluated to conclude whether the quality of study is rated as high quality (++),
17
acceptable (+) or unacceptable (reject 0).
2.2: Results
2.2.1: Date of search and search history
The articles were searched from March 2014 to July 2014. In total, 4 articles
were found from Pubmed and CINAHL during the initial search. The reference lists of
these 4 articles were assessed and 13 articles were found to be related after reviewing
titles, abstracts and full texts. To enrich the findings, Google scholar was used as a
final database for searching and yielded 1 more article. After removing duplications, 7
articles were included. English language was found in 6 articles and 1 article in
Persian. Randomized controlled trial (RCT) study was found in 6 articles while 1
article was controlled trial study without randomization. All of the studies were
related to the cold application around the skin of the chest tubes for the CTS patients
before CTR and the pain levels perceived by the patients immediately and after the
procedure were assessed. Appendix 1 had shown details about the searching history.
2.2.2: Study characteristics
From the 7 included articles, all of them were prospective design studies. RCT
study was found in 6 articles while 1 article was controlled trial (CT) study without
randomization. Moreover, 2 articles were crossover design studies. These studies
conducted in various countries, including 1 from Saudi Arabia, 1 from USA, 2 from
18
Turkey and 3 from Iran. No local study was found after the search. Cardiac surgical
patients were focused in 5 articles, thoracic surgical patients were focused in 1 article
and both cardiac and thoracic surgical patients were focused in 1 article. Each patient
has at least 2 chest tubes (pericardial, mediastinal or pleural chest tubes) in 6 articles
and 1 chest tube in 1 article. Regarding the interventions, cold application was applied
in combination with pharmacological method in 5 articles (acetaminophen in oral or
intravenous form, indomethacin suppository or midazolam in intravenous form) and
cold application was applied alone in 2 articles. Ice packs were applied to the patients
in 3 articles while cold gel packs were applied in 4 articles. When compared with the
study sites, 5 of the studies conducted in ICU, 1 in CCU and 3 in postoperative
surgical units. Multisite studies were found in 2 articles. Table of evidence was shown
in Appendix 2 for details.
2.2.3: Methodological Quality
All the articles had mentioned a clear and appropriate PICO question. Although
randomization was mentioned when assigning patients into different groups for 6
RCT studies, only 2 articles mentioned the randomization methods in details. These
methods included assigning patients into different groups according to the random
numbers generated by the Excel software in the computer (Gorji et al., 2014) and
drawn out cards coded with 3 groups randomly by the researchers for each patient
19
before the crossover study (Mazloum, Abbasi, Kianinejad & Gandomkar, 2012). For
the controlled trial article, the patients were assigned to the groups according to the
odd-dated days and even-dated days of being recruited in the month without
randomization (Ertug & Ulker, 2011). However, no concealment methods to the
researchers were clearly mentioned when assigning patients into different groups for
all the articles.
Single blinding method was used in 5 articles. Patients were ‘blinded’ for 4
articles and assessor was ‘blinded’ in 1 article. Patients could only be ‘blinded’ for
those studies with a placebo group (placebo bag application). The nurse for recording
pain level was trained and was ‘blinded’ to the treatments being applied to the patients
in Gorji et al. (2014) study. This could help increase the inter-rater reliability during
the measurement.
The demographic characteristics of the patients in intervention and comparison
groups were similar for all the articles before the studies began. However, the pain
level before CTR between the cold application and placebo groups showed a
significant difference in Otaibi, Mokabel & Ghuneimy (2013) study, which affected
the rigor of the results.
The only difference between the intervention and control groups was the
treatment applied to the corresponding group. CTR was performed by 1 health care
20
professional (Demir & Khorshid, 2010; Gorji et al., 2014; Mitra et al., 2014) or by
few physicians following a standard protocol (Ertug & Ulker, 2011). Nevertheless, in
Sauls (2002) article, the investigator present during the procedure had provided
explanations to some of the patients on request, which might cause another difference
in treatment between the groups. Moreover, 7 health care professionals of different
expertise performed CTR, which might create some extraneous variables.
Pain level was the main primary outcome for all the studies, which was measured
by numerical rating scale (NRS) (Sauls, 2002) or visual analogue scale (VAS) for the
other 6 articles. Anxiety level was measured in 3 studies (Demir & Khorshid, 2010;
Otaibi et al., 2013; Sauls, 2002). Reliability and validity of the measuring tools were
supported by previous literatures for all the articles. No patients dropped out from all
the studies but only occurred in Mitra et al., (2014) article. The drop out percentage
was 3.03%, which was less than 20% and regarded as acceptable (SIGN, 2012).
Nevertheless, no intention-to-treat analysis was conducted to analyze these dropped
out patients.
Not all the articles mentioned the statistical power of the samples. To minimize
type 2 error, sample size of power >0.8 and alpha <0.05 should be needed. 0.81 was
reported in Demir & Khorshid (2010) study while 0.99 were reported in Ertug &
Ulker (2011) and Gorji et al. (2014) studies. When viewing the sample size, Sauls
21
(2002), Otaibi et al. (2013) and Mitra et al. (2014) articles showed inadequate patients.
This might affect results generalizability.
Although 2 studies were conducted in multisite (Otaibi et al. 2013; Sauls, 2002),
none of them provided specific results obtained in particular site in order to have a
comparison.
In general speaking, all the articles were rated acceptable (+) except Sauls (2002)
study, which was rated unacceptable (0). Nevertheless, Sauls (2002) article was the
earliest study related to the cold application before CTR and latter studies had revised
the methods used based on it. Therefore, this study can still act as a reference material.
Details of the methodology quality refer to Appendix 3.
2.3: Summary and synthesis
2.3.1: Summary of results
There was a significant decreased in pain level (p<0.05) perceived by the
patients in the cold application group when compared with those in the comparison
groups (placebo or control groups) immediately after CTR for all the articles except
Sauls (2002) study, which showed a non-significant decreased in pain level (p>0.05).
The sustained effect of cold application on pain level was measured 15 minutes after
CTR for 5 articles (Demir & Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012;
Mitra et al., 2014; Otaibi et al., 2013) and 5 minutes after CTR (Ertug & Ulker, 2011).
22
All of them showed a significant decreased in pain level (p<0.05) in cold application
group when compared with the comparison groups. Nevertheless, there were
non-significant decreased in pain level (p>0.05) in Sauls (2002) study 10 minutes
after CTR and Mitra et al. (2014) 15 minutes after CTR.
Apart from pain level, 3 articles had reported anxiety level perceived by the
patients after CTR. In Otaibi et al. (2013) article, the anxiety scores measured by
using Hamilton anxiety rating scale (HAM-A) showed a significant decreased in
anxiety level after CTR. However, in Demir & Khorshid (2010) article, the anxiety
scores recorded by using Spielberger situational anxiety level inventory (STAI-I)
showed a non-significant decreased in anxiety level (p>0.05) in cold application
group 15 minutes after CTR when compared with both placebo and control groups.
Non-significant results also produced in Sauls (2002) article, in which the distress
level for either immediately or 10 minutes after CTR showed non-significant results
(p>0.05).
The mean ages of the participants were ranged from 55-60 years old for 5 articles
(Demir & Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012; Mitra et al., 2014;
Sauls, 2002) while 2 articles showed mean ages from 40-50 years old (Ertug & Ulker,
2011; Otaibi et al., 2013). 5 articles combined cold application with pharmacological
method together before CTR. In Demir & Khorshid (2010) study, 10mg/kg
23
paracetamol in intravenous form was injected 60 minutes before CTR for all the
groups. Both Gorji et al. (2014) and Otaibi et al. (2013) studies prescribed
acetaminophen oral pills as their pharmacological method. In Otaibi et al. (2013)
study, 1 gram acetaminophen oral pills were given 60 minutes before CTR while for
the Gorji et al. (2014) study, acetaminophen pills were given round the clock for every
6 hours without mentioning the dosage given each time. For Mitra et al. (2014) study,
indomethacin suppository of 100mg was inserted 60 minutes before CTR. Finally,
unmentioned dosage of midazolam in intravenous form was given to all groups before
CTR in Mazloum et al. (2012) study.
The selected articles had reported different cold application area around the chest
tubes. In Sauls (2002) article, a cold pack was applied at either side of the chest tubes
by covering 38.7cm² of the skin while in Ertug & Ulker (2011) study, cold packs were
applied around the chest tube covering 6.125cm² of the skin. In Demir & Khorshid
(2010) study, a cold pack was bent and being applied around the chest tubes
occupying 5 cm³ of the skin. Cold packs were applied around skin of the chest tubes
for other articles but no specific area was being mentioned. Besides, the length of time
in applying cold application was different in the selected articles. 10 minutes was
spent in cold application before CTR in Sauls (2002) study while 20 minutes was
spent in Demir & Khorshid (2010), Mazloum et al. (2012) and Mitra et al. (2014)
24
studies. Temperature measurement was another indicator for the time length of cold
packs application. In both Ertug & Ulker (2011), Gorji et al. (2014) and Otaibi et al.
(2013) studies, cold packs would be removed when the skin temperature around the
chest tubes reached 13°C. Appendix 2 had shown detailed results.
2.3.2: Synthesis of results
Among all the selected articles, all of them showed statistically significant results
in decreasing pain level in cold application group when compared with comparison
groups immediately after CTR except in Sauls (2002) study. Cold application effect
on decreasing pain level also sustained for a period of time among the majority of the
selected studies, except Sauls (2002) and Mitra et al. (2014) studies.
The contradictory results on pain level in cold application group showed by
Sauls (2002) article could be due to several factors. Firstly, the ice pack applied only
to either side of the chest tube but not totally covered the surrounding skin, which
might weaken the cooling effect. In addition, spending 10 minutes for applying the ice
pack by the health care professional was too short and inadequate for the ice pack to
produce cooling effect thoroughly. On top of this, to determine whether the effect was
due to cold application or not, placebo group was used. A tap water pack of 30.6°C to
31.7°C was applied to the patients in placebo group, which might actually cool down
the skin of the patients in placebo group. Moreover, the patients were not ‘blinded’ to
25
the treatments and the differences between the two groups were not only the treatment
itself, but also the extra explanations provided by the investigator to patients on
requests, which created extraneous variables to the study. Finally, the sample size
(n=25 for each group) was small, which increased the chance of accepting a null
hypothesis (Type 2 error). Although power analysis was not mentioned in Mitra et al.
(2014) article, by estimation, the sample size was not adequate as only 32 patients in
the cold application group and 34 patients in placebo group. In addition, the study did
not apply intention-to-treat analysis with the results of 2 withdrawn patients in the
cold application group being ignored, which might contribute to the non-significant
result in pain level 15 minutes after CTR.
In contrast, cold packs were applied and covered certain area of the skin
surrounding the chest tubes in the cold application group instead of covering just one
side of the skin among all the articles selected. For the intervention duration, cold
application time extended from 10 minutes to 20 minutes (Demir & Khorshid, 2010;
Mazloum et al., 2012; Mitra et al., 2014) or used temperature reading (13°C) as an
indicator to ensure adequate cooling (Ertug & Ulker, 2011; Gorji et al., 2014; Otaibi et
al., 2013). Furthermore, 2 comparison groups (placebo and control groups) were used
(Demir & Khorshid, 2010; Mazloum et al., 2012). The present of placebo packs might
somehow provided some cooling effect to the skin and also caused patients to think
26
that placebo bags could help reduce their pain, which affected their perception of pain
(Bal, 2002; Kocaman, 1994, as cited in Demir & Khorshid, 2010). The control group
could help counteract these effects in the placebo group. Single blinding method was
used by either ‘blinded’ the patients between cold application and placebo groups
(Demir & Khorshid, 2010; Mazloum et al., 2012; Otaibi et al., 2013; Mitra et al., 2014)
or ‘blinded’ the assessor to the treatments being received by the patients (Gorji et al.,
2014), which could reduce biases to the results. Finally, adequate sample sizes of
power 0.81 in Demir & Khorshid (2010) and power 0.99 in Ertug & Ulker (2011) and
Gorji et al. (2014) studies could help reduce Type 2 error. These improvements help
contribute to significant results.
Effect size of pain control by applying combination method (cold application +
pharmacological method) and cold application alone could be compared. The effect
size immediately after CTR was the largest in Otaibi et al. (2013) combination
method study, which was -5.95. However, only 40 patients were recruited during the
study. Although there was no mention about the power analysis of the study, the
sample size 40 in this study was lesser than Sauls (2002) article, which recruited 50
patients and produced non-significant results. By estimation, the power of the sample
was small to generalize the result to other patients. The second large effect size was
Gorji et al. (2014) combination method study, which was -2.2. Several factors
27
contributed this study to get a large effect size, such as a good randomization method
was used by generating random numbers from the Excel programme in computer for
assigning patients into different groups, single blinding method was used to ‘blinded’
the assessor to the treatments before CTR and adequate sample size (power = 0.99 for
alpha <0.05). The largest effect size in cold application alone study was Ertug &
Ulker (2011), which was -1.75. The effect size in Ertug & Ulker (2011) article was
lower than Gorji et al. (2014) article. Although the effect size for 15 minutes after
CTR was small in Gorji et al. (2014) article, which was -0.22, the mean pain score for
the cold application group was 0.42 and was lower than Sauls (2002) and Ertug &
Ulker (2011) articles, which were 1.68 and 1.13 respectively.
In summary, combination method seemed to be more effective in pain control
when compared with cold application alone. One has to notice that in Mazloum et al.
(2012) study, although the effect size had shown significant reduction in pain levels
immediately and 15 minutes after CTR and the mean pain scores of the cold
application group were low, which were 2.5 and 0.6 respectively, the midazolam used
in this study might increase the chance of having complications and required close
monitoring for the CTS patients as discussed before. Therefore, it was not suitable to
be used in common postoperative CTS units.
In view of the demographic characteristics of the patients among the articles
28
being selected, the mean ages of the patients ranged from 40-60 years old and BMI<
30kg/m², which were somehow homogenous. However, there was lack of report about
the religious belief and cultural background of the patients. These factors would affect
the perception to pain by the patients (Mitra et al., 2014). Finally, only Ertug & Ulker
(2011) and Gorji et al. (2014) recruited patients with no CTR experience before the
studies. Patients might compare current event with their previous experience, which
affected their true pain perception (Ertug & Ulker, 2011).
Anxiety level experienced by the patients during CTR was another primary
outcome being reported in 3 selected articles (Demir & Khorshid, 2010; Otaibi et al.,
2013; Sauls, 2002). Anxiety was regarded as an indicator for postoperative pain, the
increase in its level would reduce pain threshold of the patients which leaded to pain
level overestimation. It was thought that the increase in pain level contributed to the
increase in anxiety level and vice versa (Milikan et al., 2008, as cited in Otaibi et al.,
2013). In Otaibi et al (2013) study, the anxiety level measured by HAM-A scale had
shown a significant reduction (p<0.05) in cold application group when compared with
the placebo group. The correlation between pre-CTR anxiety level and pain level 15
minutes after CTR were significant (p<0.05). On the other hand, both the Sauls (2002)
and Demir & Khorshid (2010) showed non-significant results in decreasing anxiety
level in cold application group when compared with the comparison groups. These
29
results could be explained by the environmental factors. Several patients were
assigned in a room and the medical activities of the other patients might distract and
affect the anxiety level perceived by the patients who were undergoing CTR (Sauls,
2002). In addition, the small sample size in Sauls (2002) article also affected the
results generalizability. However, the variations of anxiety levels were the same trend
as the variations of pain levels during and after CTR for these two studies, which
supported the previous literature findings. In view of this importance, future studies
should report anxiety levels experienced by the patients during and after CTR to study
its relationship with pain level perception.
2.3.3: Conclusion
After analyzing these articles, conclusions are made here,
1: Applying cold application for CTS patients before CTR is efficacious in reducing
pain level perceived by them immediately and effect sustained certain time after CTR.
2: Combination method (pharmacological method + cold application) is more
effective in pain control than applying cold application alone.
3: Anxiety level is an important indicator for pain level perceived by the patients.
Future studies should report the correlation between anxiety level and pain level
perceptions.
4: Cultural background and religious belief of the patients should be reported in the
30
future studies as these factors may affect patient’s pain perception.
5: Cold application is a cheap, safe and easy to handle intervention. This intervention
is worth and has potential to be transferred to local hospitals.
31
Chapter 3: Translation and application
After reviewing the selected clinical studies, it has been shown that applying
cold application to the CTS patients before CTR is efficacious in reducing pain level
perceived by them immediately and certain period after CTR. Although the effects of
this new programme have been demonstrated in previous literatures, the
implementation potential in terms of transferability, feasibility and cost and benefits
of this new programme should be examined to determine whether it is suitable to be
implemented in the local setting and deserves to be maintained in the long run.
3.1: Transferability of findings
3.1.1: Target setting and population
The local setting for implementing this new programme is a male postoperative
surgical ward, which is a main cluster hospital and includes CTS cases. According to
the Hospital Authority (2006-2010) surgical statistics, there were 150 CTS patients in
this hospital from 2008 to 2009, in which 138 patients received ultra-major to major
surgeries. The number increased to 209 patients from 2009-2010, in which 181
patients received ultra-major to major surgeries. Chest tubes are usually inserted after
CTS ((Mitra et al., 2014; Sauls, 2002) and the increase in CTS patients each year also
indicates that more of them can benefit from this new programme when undergoing
CTR.
32
3.1.2: Similarities and differences between local and literature settings
Basically, the characteristics of the patients were similar for both local and those
mentioned in the literatures, including the age ranges, the type of surgery performed,
the locations of the chest tubes and the settings in performing CTR. Nevertheless,
some of patients underwent major surgeries or required critical care might create
minor difference in pain perception, for examples, cardiac surgeries (Demir &
Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012; Mitra et al., 2014; Sauls,
2002), pericardial and mediastinal chest tubes (Gorji et al., 2014; Mazloum et al.,
2012; Mitra et al., 2014; Otaibi et al., 2013), critical cases in ICU or CCU (Demir and
Khorshid, 2010; Gorji et al., 2014; Mazloum et al., 2012; Mitra et al., 2014; Sauls,
2002).
Besides, there were no Chinese patients being recruited in the literatures.
Although patients of different nationalities might affect their pain perceptions due to
cultural and religious differences, patients in both settings reported great discomfort
during CTR. Therefore, new pain management should be considered to relieve their
pain. Detailed comparisons of patient’s characteristics have been shown in Appendix
4.
3.1.3: Philosophy of care
The prevailing philosophy of CTS care in the local setting is to reduce the event
33
of postoperative complications such as pneumonia, atelectasis and cardiovascular
associated problems, which will increase the fatal probability after the surgery. In
view of this, the new programme introduced is compatible to the philosophy of CTS
unit in the local setting, which focuses on pain relief of patients during CTR
procedure to reduce the event of associated cardiothoracic complications.
Nevertheless, this new programme introduces cold application as a non-invasive
approach to relieve patient’s pain during CTR procedure, which is different from the
prevailing local setting by using invasive pharmacological methods. The non-invasive
approach in this new programme can help reduce the vulnerability caused by
traditional invasive pharmacological methods to the CTS patients.
3.1.4: Periods for implementation and evaluation
In this new programme, panadol in oral form will be given 1 hour before CTR
and regularly every 6 hours after CTR for 1 day. The cold application takes around 20
minutes before CTR and the effect can be observed immediately and sustains around
15 minutes after CTR for each patient. The effect of this new intervention can be
evaluated 6 months and annually after the implementation.
3.2: Feasibility of findings
3.2.1: Manpower and attitudes of the nurses
There are 25 nurses in the target ward. Less than half of them have the
34
experience of 6 years or above working experiences in surgical unit while the
remaining nurses have 3 years or below experiences. Although lack of senior nurses
may affect service quality, most of the junior nurses are graduated from universities
and studied evidence based practices before. They are more willing to commit
changes and easy for them to accept and digest the new findings (Alanen, Valimaki &
Kaila, 2009).
Attitudes of the nurses are crucial for implementing an innovative programme
(Alanen et al., 2009). Firstly, the departmental manager (DOM) and ward manager
advocate nurses to use eKG database in intranet to update their nursing knowledge.
They also encourage nurses to bring up Kaizen projects in order to improve the
nursing care in ward. On the other hand, the majority of the nurses in the target ward
recognize that the pain control for CTS patients during CTR is not good and higher
chance for them to suffer from respiratory and cardiovascular complications. These
complications delay the recovery process and increase the time and workload for the
nurses to close monitor their patients. Therefore, they are willing to explore changes
to improve this situation.
3.2.2: Training sessions and environment
This new programme consists of two parts, which are drug administration and
cold application. Administration of medication is the daily work for all the nurses and
35
they are already familiar with the procedures (3 checks 5 rights). Therefore, cold
application training should be provided since all the nurses in the local setting are not
familiar with it. There will be total 3 training sessions in 3 consecutive weeks, i.e. 1
week with 1 training session. Each training session is 1 hour in duration. Each nurse
only needs to attend 1 session since the contents of all sessions are the same. The
training sessions will be hold at treatment room in the ward from 14:30 to 15:30. This
time arrangement can facilitate A shift nurses to attend after duty handover and the
treatment room is usually available during that period. The treatment room is a place
for performing minor operations and dressing materials such as dressing pads are
located there. It is spacious enough to accommodate a group of nurses to attend the
training and also a preferred place for performing CTR.
Total 8 nurses are recruited in each training session. The training sessions
consists of 2 parts, which are demonstration and re-demonstration parts. A senior
physiotherapist in the same hospital will be invited by ward manager as a speaker
since physiotherapist has more experience in applying cold application to reduce
muscle and inflammatory related pains (Gorji et al., 2014). A nurse will be invited as a
real model for the physiotherapist to demonstrate the cold application procedure. After
demonstration, 2 nurses will form a group and re-demonstrate the techniques.
3.2.3: Multi-discipline co-operations
36
A good co-operation between nurses and other disciplines is a crucial factor for
implementing a new programme successfully (Alanen et al., 2009). There are good
experiences in co-operation between doctors, nurses and other allied health disciplines,
such as colorectal fast tract patient care project in the target ward. This programme
enhances the recovery of colorectal patients after the surgery. With this previous
experience, multi-discipline co-operations should be easily established for this new
programme.
In usual practice, doctors perform CTR in their convenient time without noticing
the responsible nurses. Lack of preparation time will affect the implementation of this
new programme. The DOM and the ward manager can hold a meeting with the
consultants of CTS to discuss the issues including the benefits of implementing this
new programme and improve the communications between doctors and nurses.
The support from physiotherapists is also important. According to Kol, Erdogan,
Karsh & Erbil (2013), the pain caused by the CTR may increase postoperative
atelectasis and delay the recovery process. Therefore, they should be welcome to be
invited as a speaker in cold application training and share their experiences.
3.2.4: Tools for evaluation
As mentioned in the literatures, visual analogue scale (VAS) was used for
patients to rate pain level. Nurses in the target ward were needed to record pain level
37
of their patients per shift by using numerical rating scale (NRS) instead of VAS. The
advantage of using VAS over NRS is that it facilitates the measurement in continuum
and in normal distribution, which can provide higher sensitivity (Collins, Moore &
McQuay, 1997, Flaherty, 1996; as cited in Kahl & Cleland, 2005). The original pain
chart can still be used, but using the VAS to replace NRS. The time for requesting
additional analgesics after CTR is also recorded. The record chart is shown in
Appendix 5. Briefing for using the record chart can be done after the cold application
re-demonstrations in the training session.
The effect of the new programme can be evaluated preliminary by a working
group 1 month after the implementation. A formal evaluation can be done by holding
multi-discipline meeting 6 months and annually after the implementation. Based on
the clinical data, nurses have the rights to suggest rooms for improvement to the
programme.
3.3: Costs and benefits
3.3.1: Individual benefits and risks
For the CTS patients, the main benefit for implementing the new programme is
the decrease in pain level during CTR, and thus reduces the probability of having
respiratory and cardiovascular complications (Gorji et al., 2014; Kol et al., 2013).
Moreover, panadol as a less potent analgesic together with the cold application can
38
replace the use of more potent analgesics such as morphine and cause less
vulnerability to CTS patients (Gorji et al., 2014).
The risks for patients to receive this new programme are relatively low. The
panadol administered is 1 gram per time every 6 hours, which will not exceed the
maximum dosage for an adult per day and causes liver damage. Nevertheless, the cold
application may cause discomfort for those who are oversensitive to cold (Gorji et al.,
2014). Otherwise, this new programme is overall safe for CTS patients.
For the nurses, the preparations for cold application are mainly the source of
increased workload. Nevertheless, nurses can gain job satisfaction form this new
programme since patients are more willing to establish a rapport relationship with
them. Patients think that their nurses concern their pain and enhance them to work
together in recovery phases.
The bed statistics is around 45 or above per day in the target ward, in which CTS
patients occupy 6 beds in maximum. There are around 7-8 nurses per shift. The most
senior nurse is the in-charge nurse (IC). There are 4 cubicle IC nurses being assigned
to care patients. The 2 cubicle IC nurses, each care 10 patients in maximum while the
other 2 cubicle IC nurses care the remaining patients evenly. Other nurses are runners
to assist the cubicle IC nurses. To share the increased workload evenly among them,
CTS patients can be evenly distributed to those 2 cubicle IC nurses who are
39
responsible for lesser patients and change the cubicle IC nurses regularly after a PA
shift.
For the doctors, the new programme implemented can relieve the pain level
suffered by the CTS patients. Patients are more willing to have early ambulation after
CTR and thus reduce the chance of having respiratory complications like atelectasis
(Kol et al., 2013).
Nevertheless, doctors need to spend time to wait for the preparations before CTR,
which only take few minutes for them to perform the procedure in the past. Their
daily work maybe interfered. This problem can be solved with the following
management. For example, if 2 patients are planned to have CTR after morning round,
doctors can prescribe panadol in the medication chart and phone contact the nurses 1
hour prior they come so that the nurses have enough time to administer medication
and perform cold application to the patients. The preparations for the second patients
can be applied 5 minutes later than the first one so that doctors can perform CTR
consecutively one by one. Therefore, doctors do not need to spend time for waiting
but perform their daily works as usual.
3.3.2: Material costs of the institution
Firstly, the set-up cost for this new programme will be the time for training. A
senior physiotherapist will be invited to spend total 3 hours for demonstration while
40
24 nurses use total 24 hours to attend the training sessions. One solution to
compensate for the nurses is to mark the additional working hours in the overtime
record and allow them to leave early from work in later time.
Besides, the equipments required for this new programme are silica gel cold
packs, a refrigerator with a digital sensor keeping temperature at +4°C to store the
cold packs, dressing pads, mefix and hourmeters. These materials are originally
present in the ward for febrile patients and for daily wound dressings. Therefore, no
set-up costs will be needed for these materials but only small amount of budgets are
needed for operational costs.
Finally, there are potential reductions in using analgesics and antibiotics due to
decrease in pain and respiratory distress complications after implementation of this
new programme. Patients are more willing to perform deep breathing and ambulatory
exercises after CTR and may decrease the use of these drugs (Kol, et al., 2013). The
length of stay in hospital can also be reduced.
After calculating the above costs and benefits, the potential budgets saving for
implementing this new programme is $1901848 per year. Detailed information can
refer to Appendix 6.
3.3.3: Non-material costs of the institution
The cold application may collide with other medical activities in using the
41
treatment room. Therefore, it can be applied at patient’s bedside for 20 minutes and
perform the CTR procedure in the treatment room. This arrangement can minimize
the inconvenience.
This new programme enhances the multi-discipline co-operations. Morale among
the health care staffs will be increased since their efforts are being affirmed by their
patients. Health care projects involved multi-disciplines can be promoted to provide
good quality of care to the patients in the future.
3.4: Evidence-based practice guideline
After assessing the transferability, feasibility and costs over benefits ratio of cold
application programme as mentioned in the literatures, basically it is applicable in
local setting. An evidence based guideline that meets the local needs should be
developed to guide the implementation.
3.4.1: Guideline title
Cold application programme in reducing procedural pain due to CTR
3.4.2: Objectives
The aim of this guideline is to relieve the procedural pain suffered by the CTS
patients during CTR. The guideline can help:
1: pick up appropriate CTS patients who are going to undergo CTR,
2: standardize the pain relief preparations before CTR,
42
3: serve as a revision material for those new comers who are not familiar CTR pain
control.
3.4.3: Target populations
This guideline is intended to all the nurses who are going to provide pain relief
preparations for the CTS patients before CTR procedure in a local postoperative
surgical unit. The inclusion and exclusion criteria of the patients are shown below.
Inclusion criteria:
1: Patients with ages 20 or above.
2: Patients oriented to time, place and person.
3: CTS patients with at least one chest tube or above undergoing CTR.
4: Able to understand and rate pain level by using VAS.
Exclusion criteria:
1: Patients who are having psychiatric diseases or dementia.
2: Patients who are having poor visual acuity or blinded.
3: Patients who are oversensitive to cold and allergic to panadol.
3.4.4: Evidence based recommendations
After summarizing and synthesizing the literatures included in Chapter 2 and
other related articles, some of the statements are extracted. The levels of evidence and
grades of recommendations for these statements are determined according to Scottish
43
Intercollegiate Guidelines Network (SIGN) (2012), which is shown in Appendix 7.
The statements are shown below:
(1): VAS is an appropriate tool for assessing patient’s pain level during CTR. (Grade
of recommendation: B)
(2): Cold application together with less potent analgesics can effectively reduce CTR
procedural pain suffered by the patients. (Grade of recommendation: A)
(3): Silica gel cold packs are more effective in providing cooling effect than ice packs.
(Grade of recommendation: A)
(4): The duration for cold application and temperature should be 20 minutes and
around 0-5°C in order to provide adequate analgesic effects to the patients. (Grade of
recommendation: A)
(5): The analgesic effects of cold application can be evaluated by VAS and mean
length of time before patients request for additional analgesics after CTR. (Grade of
recommendation: A)
The detailed evidence of the statements and operational checklist are provided in
Appendix 8 and 9 respectively.
44
Chapter 4: Implementation plan
The transferability, feasibility and costs and benefits of cold application
programme have been analysed and being shown to have potential in local setting.
Nevertheless, it is still questionable whether the programme can be easily adopted and
complied by the nurses. Therefore, in this chapter, strategies to strengthen the
compliance and sustainability of the programme will be discussed.
4.1: Communication plan--- An overview
The communication and evaluation processes for implementing the programme
consist of 4 phases. The first phase is to introduce the involved parties about the cold
application programme. The second phase focuses on forming a work group to refine
and promote the programme. The third phase is to perform a pilot study to examine
feasibility. The fourth phase is to evaluate data from the pilot study to revise the
programme. Detailed timeline is shown in Appendix 10.
4.1.1: Stakeholders identification
To implement a new programme, it is crucial to identify those stakeholders who
are affected by the new practice or the results caused by that innovation. The
Programme Coordinator (PC) can have a better understanding about the influences of
the new programme to different parties and help convince them to adopt it (Grol &
Grimshaw, 2003). The stakeholders are:
45
1: Programme Coordinator (PC), i.e. the author, who is responsible to review the
clinical evidences from literatures and analysed them systematically, disseminate the
clinical findings to different parties and coordinate them to implement changes.
2: Departmental operational administers or budget holders including the Consultant
(Cons) of CTS, the Departmental Operation Manager (DOM) and the Ward Manager
(WM).
3: Senior leaders who have rich experience in their working fields and act as opinion
providers in daily practice. For example, the CTS Assisted Consultant (AC), the CTS
Medical Officers (MO) and the 4 Advanced Practitioner Nurses (APN).
4: Frontline staffs. The 21 registered nurses (RN) are responsible to implement the
programme.
5: Cold application trainer, i.e. the senior physiotherapist.
6: CTS patients who are undergoing CTR.
4.1.2: Forming a working group
To implement a new programme, the PC should first gain support from the
colleagues. It is not easy to implement a change even it is developed according to
evidence. Marketing theories suggested that the targeted stakeholders should receive
clear and attractive messages in order to perform a change (Grol & Grimshaw, 2003).
Therefore, after reviewing the literatures, the PC can grab the chance to present the
46
basic idea of cold application programme among the nurses during ward meeting. The
presentation contents include the inadequacy of pain control for CTS patients during
CTR, the benefits of applying cold application programme for pain control and the
transferability and feasibility of applying it in local setting. Lastly, a brief introduction
of the clinical protocol can be delivered to them. After the meeting, the issue of pain
control among CTS patients during CTR can be raised among the nurses, which can
initiate them to ask questions regarding to the implementation and more likely for
them to support the new practice.
Secondly, WM can help report this proposal to DOM and Cons of CTS
department to seek approval and resources allocation. After gaining approval, a
working group can be formed. The working group includes WM, 1 AC and 1 MO of
CTS department, 4 APN, 1 senior physiotherapist, PC, and 3 Registered Nurses (RN)
who have shown interests to the new programme during ward meeting.
4.1.3: Roles of working group
There is a division of labor within the working group. The WM can help arrange
duties to facilitate nurses to attend the training sessions. Besides, the WM can invite a
senior physiotherapist as a cold application trainer and allocate resources for the
programme.
According to social influence theory, the presence of senior leader can act as a
47
role model to a new practice so that other staffs will obey and follow it (Grol &
Grimshaw, 2003). Therefore, the senior leaders in the working group can help
influence and motivate other staffs to implement the programme. Besides, the senior
leaders can offer some opinions based on their experiences to modify the clinical
protocol to make it more feasible to be implemented.
The senior physiotherapist acts as a cold application trainer to train nurses for
cold application techniques.
The PC and the 3 RN are responsible to create a folder related to cold application
programme. The clinical protocol will be attached in this folder and being placed near
the nursing station so that other nurses can easily access and have a quick reference
for the procedures. In addition, posters will be designed and the programme details
will be sent via intranet email in order to let nurses keep update about the programme.
The PC and the 3 RN will apply their learnt cold application techniques in the pilot
study to examine the feasibility of the programme.
Lastly, the sustainability of the programme is a major concern. According to Grol
& Grimshaw (2003), staff compliance to a new programme determined by several
factors, which are the compatibility of the proposed changes to the prevailing
philosophy in local setting, procedures’ complexity, new skills required and the
clinical outcomes.
48
In view of these factors, a meeting can be held between the working group and
nurses 1 month after the pilot study. The working group members can share the results
of the pilot study, including the difficulties and feasibility when implementing the
programme, with other nurses to seek for their opinions. They can also reassure other
nurses that the resources needed for the programme were already exist and the new
skills required are only the cold application techniques. Adequate training sessions
will be provided to the nurses to clarify questions before implementation. Besides, the
working group can announce that the programme will be fully implemented after the
training sessions and welcome other nurses to seek help from them when encounter
any difficulties. These arrangements can enhance nurses’ acceptance to the
programme.
Patient’s pain level in terms of VAS can be collected by the working group and
discussed with other nurses during ward meeting 1 month and 6 months after full
implementation and the annual departmental Kaizen meeting. With these successful
stories, nurses are inspired and more likely to participate actively to the programme
(Grol & Grimshaw, 2003).
4.2: Pilot study
The purpose of conducting pilot study is to apply the new practice into smaller
sample to examine the feasibility before full implementation (Leon, Davis & Kraemer,
49
2011). The contents include patient’s recruitment, communication processes between
various members and barriers noticed during implementation. Through evaluations,
revisions can be done to the progamme before it is largely applied to a clinical unit
(Leon et al., 2011).
4.2.1: Patient’s recruitment
According to past records, around 4 CTS patients underwent CTR per week.
Therefore, 8 CTS patients who are eligible as mentioned in the clinical protocol will
be selected over 2 weeks. The selected patients will be arranged to two groups evenly,
which are cold application (intervention) and control groups. Once they are selected,
the working group will approach them and explain clearly about the benefits and risks
of joining the study and obtain a written consent at that time.
4.2.2: Rundown testing
Several items can be tested during the pilot study. Firstly, the PC and 1 RN in the
working group will be the responsible nurses for the intervention group. They will be
assigned as the cubicle IC in a cubicle (maximum patients = 10). The cubicle IC is
responsible to check the CTR order from the kardex after morning round and
administer 1 gram panadol to the patient 1 hour before CTR and round the clock
every 6 hours. Besides, a silica gel cold pack of +4°C will be applied by the cubicle IC
around the chest tube at bedside for 20 minutes before CTR. Then the patient will be
50
transported to the treatment room and the cubicle IC will assist the CTS MO to
perform CTR. For the control group, the other 2 RN in the working group will be
arranged as the cubicle IC and repeat the same procedures except cold application.
These arrangements can examine whether a trained nurse can bear the increased
workload due to the new programme.
Besides, the CTS MO should inform the coming time to the responsible nurses
for CTR. This is crucial if there are 2 or more selected patients need to undergo CTR,
so that the nurses can gain enough time for preparations. The adequacy of
communications between the medical professionals can then be examined.
Lastly, the responsible nurses will assess patient’s pain level in terms of VAS by using
the pain chart before and after CTR. The data recorded will be documented in the
progress notes as shown in Appendix 11 or 12. Through the assessments, comments of
the programme by patients can be received. Besides, the difficulties in pain level
assessments and nurses’ documentations can also be identified.
The senior leaders in the working group are responsible to supervise and monitor
the whole implementation processes and provide opinions during evaluations.
4.2.3: Pilot study evaluations:
The results of the pilot study can be evaluated by the working group by holding a
meeting 1 week later. Several issues, such as patient’s comments to the programme,
51
concerns about the increased workload for the nurses and resources arrangement can
be discussed. These evaluations can help refine the programme before it is fully
implemented.
4.3: Evaluation plan
Although the cold application programme will be fully implemented after the
pilot study, regular evaluations are needed to monitor the progress and measure
clinical outcomes. These evaluations can help the programme become more effective
and safe for practice in the future (Grol & Grimshaw, 2003). Therefore, the
programme is designed to evaluate 1 month, 6 months and annually after full
implementation.
4.3.1: Patient outcomes
Patient outcomes are defined as clinical benefits received by the patients after
receiving the treatment. The primary patient outcomes for the cold application
programme are the mean pain level reduction of the intervention group immediately
and 15 minutes after CTR when compared with the control group. The formulas are
shown below:
Mean VAS(inter imm) – Mean VAS(cont imm) = Mean VAS(pain reduce imm)
Mean VAS(inter 15mins) – Mean VAS(cont 15mins) = Mean VAS(pain reduce 15mins)
(inter imm = intervention group immediately after CTR; cont imm = control group immediately after
52
CTR; inter 15mins = intervention group 15 minutes after CTR; cont 15 minutes = control group 15
minutes after CTR; pain reduce immed = pain reduction immediately after CTR; pain reduce 15mins =
pain reduction 15 minutes after CTR)
The pain level is measured using VAS. It provides a continuum for patients to
rate their pain and easily understood by them. Therefore, it is a tool with high
reliability and validity (Bijur, Latimer & Gallagher, 2003; Tamiya et al., 2002;
Williams, Davies & Chadury, 2000).
The secondary outcome for this programme is to determine the mean length of
time for requesting additional analgesics by both groups after CTR. In Demir &
Khorshid (2010) study, the difference in mean length of time between two groups
were significant (p<0.05), which can act as an indicator for patient outcome.
4.3.2: Healthcare provider outcomes
Healthcare provider support is a major element to sustain the programme. This
support includes the acceptance and competence of implementing cold application
programme by the nurses. These components can be assessed by delivering self
reporting questionnaires to the nurses during regular meetings and reviewing the
completeness and integrity of the documentations by the nurses.
4.3.3: System outcomes
Measuring system outcomes is important since it reflects the overall worthiness
53
of the programme. Several issues such as programme utilization, manpower
requirement and programme running cost will be addressed. The programme
utilization can be assessed by evaluating total number of CTS patients received the
programme before CTR annually. The manpower requirement depends on the
programme utilization annually. The programme running costs include the costs for
training sessions and paper printings are calculated annually in order to determine the
budgets.
4.3.4: Data measurements and analysis
4.3.4.1: Patient outcomes
Convenient sampling is used to select eligible CTS patients which based on the
inclusion criteria as mentioned in clinical protocol. The pain level of these patients are
recorded in pain chart and documented in progress notes as shown in Appendix 11 or
12.
When considering the primary outcomes, the mean pain level reduction before
and after CTR between two groups are analyzed using two-tailed independent
samples t-test. The sample size is determined using a sample size calculator created
by Lenth (Lenth, 2011).
Two null hypotheses are presented. The first one is the mean VAS immediately
after CTR are equal for both groups. The second one is the mean VAS 15 minutes
54
after CTR are equal for both groups.
When considering the first null hypothesis, according to the literatures, the mean
reduction in VAS in intervention group when compared with control group ranged
from 10% to 50%, with standard deviations (SD) around 59% for intervention group
and 54% for control group (Demir & Khorshid, 2010; Gorji & Nesami, 2014;
Mazloum et al., 2012). Take type 1 error = 5%, power = 80% and a modest pain level
reduction = 30%, total 114 patients are needed. If 10% drop out rate is estimated, 127
patients should be recruited.
When considering the second null hypothesis, according to the literatures, the
mean reduction in VAS in intervention group when compared with the control group
ranged from 25% to 65%, with SD around 52% for intervention group and 70% for
control group (Demir & Khorshid, 2010; Gorji & Nesami, 2014; Mazloum et al.,
2012). Take type 1 error = 5%, power = 80% and a modest pain level reduction = 40%,
total 76 patients are needed. If 10% drop out rate is estimated, 85 patients should be
recruited.
To demonstrate two effects, 127 patients should be recruited. According to the
past records, around 204 CTS patients underwent CTR annually. Therefore, recruiting
127 patients is reasonable.
When considering the secondary outcome, the time for requesting additional
55
analgesics are recorded in pain chart and progress notes. Kaplan Meier analysis can be
applied to estimate a 95% confidence interval for the mean length of time after CTR
for both groups.
4.3.4.2: Healthcare provider outcomes
The qualitative indicators for health care provider outcomes are self acceptance
and competence of implementing the programme. Questionnaires will be delivered
during evaluation meetings to collect nurses’ opinions about the programme and
assess their morale. The senior leaders in the working group will review nurses’
documentations to determine its completeness and integrity each month. If problems
are detected, they will clarify with nurses during regular ward meetings every 3
months.
4.3.4.3: System outcomes
The results of system outcomes reflect the programme utilization rate and thus
affect the manpower arrangement and budgets being spent to the programme. Once
patients have joined the programme, the PC records them in nursing summary of the
Clinical Management System monthly. The PC is responsible to write a report by
listing the number of patients received the treatment and expenses spent annually.
This report will be handed in and evaluated by the working group members annually.
4.4: Basis for implementation
56
The cold application programme is defined as success if the two-tailed
independent samples t-test show the mean pain level immediately and 15 minutes
after CTR in intervention group are significantly lower than the control group, i.e.,
with p < 0.05.
Conclusion
Cold application together with less potent analgesics (Panadol) has been shown
to be effective in reducing CTR procedural pain for CTS patients. Cold application
reduces the use of potent traditional analgesics that may bring out worse
complications to the patients. Besides, when compared between the literature and
local settings, cold application is feasible to be implemented in local CTS units. The
development of evidence based nurse-led CTR clinical protocol allows nurses to
select appropriate CTS patients and prepare the CTR procedure in a standardized way.
Last but not least, a well established evaluation plan is proposed to help identify the
clinical outcomes, which can help refine the programme and sustain it in the future.
By implementing this programme, it is hope that a rapport relationship can be built
between the nurses and patients and enhance them to work together in recovery
process.
Reference
1: Barber, F.A., McGuire, D.A., & Click, S. (1998). Continuous-flow cold therapy for
57
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Related Surgery, 14(2), 130-135.
2: Williams, A.C.de C., Davies, H.T.O., & Chadury, Y. (2000). Simple pain rating
scales hide complex idiosyncratic meanings. Pain, 85, 457-463.
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6: Grol, R., & Grimshaw, J. (2003). From best evidence to best practice: effective
implementation of change in patients’ care. The Lancet, 362, 1225-1230.
7: Sarifakioglu, N., & Sarifakioglu, E. (2004). Evaluating the effects of ice application
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single-blind controlled trial. Annals of Plastic Surgery, 53, 543-546.
8: Kahl, C., & Cleland, J.A. (2005). Visual analogue scale, numeric pain rating scale
and the McGill pain questionnaire: an overview of psychometric properties. Physical
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acute ankle sprains: a randomized controlled study of two different icing protocols. Br
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reduction of postoperative pain: prospective randomized study. Hernia, 10, 184-186.
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Hospital Authority.
12: Zahra, A., Rigi Sh.d., N., Salmeh, D., & H.A. E. (2008). Comparing the effect of
cooling gel pads and ice pack, after episiotomy on the intensity of perineal pain.
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14: Moher, D., Liberati, A., Altman, DG., & The PRISMA Group (2009). Preferred
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PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097.
15: Demir, Y., & Khorshid, L. (2010). The effect of cold application in combination
with standard analgesic administration on pain and anxiety during chest tube removal:
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11(3), 186-196.
16: New Territories West Cluster. (2010). Department of Surgery statistics in Tuen
Mun Hospital. Hong Kong: Author. Retrieved November, 16, 2014, from
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17: Ertug, N., & Ulker, S. (2011). The effect of cold application on pain due to chest
tube removal. Journal of Clinical Nursing, 21, 784-790.
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pilot studies in clinical research. J Psychiatr Res., 45(5), 626-629.
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May 5, 2015 from http://www.cs.uiowa.edu/~rlenth/Power/.
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http://www.info.gov.hk/gia/general/201205/09/P201205090336.htm
21: Mazloum, S.R., Abbasi, T.M., Kianinejad, A., & Gandomkar, F. (2012). Effect of
applying icie bag on pain intensity associated with chest tube removal after cardiac
surgery. Quarterly of Ofoghe Danesh, 18(3), 109-114.
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developer’s handbook. Scotland: Author. Retrieved December 1, 2014, from
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http://www.sign.ac.uk/guidelines/fulltext/50/annexoldb.html
23: Kol, E., Erdogan, A., Karsh, B., & Erbil, N. (2013). Evaluation of the outcomes of
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& Rana, M. (2013). Three-dimensional evaluation of postoperative swelling in
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randomized, observer-blind, prospective study. Trials, 14(238), 1-10.
25: Otaibi, R.A.A., Mokabel, F.M., & Ghuneimy, Y.A. (2013). The effect of cold
application on pain and anxiety during chest tube removal. Journal of American
Science, 9(7), 13-23.
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checklist. Scotland: Author. Retrieved April 14, 2014, from
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27: Gorji, M.H., Nesami, M, B., Ayyasi, M., Ghafari, R., & Yazdani, J. (2014).
Comparison of ice packs application and relaxation therapy in pain reduction during
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Sciences, 6(1), 19-24.
28: Mitra, P.B., Nahid, D., Nouraddin, M., & Eskandar, N. (2014). Effect of cold
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62
Appendix 1: Search history (PRISMA Flow Diagram)
Identification
Literatures identified through database searching
(n = 13)
Additional literatures identified through other sources
(n = 1)
Literatures after duplicates removed (n = 7)
Screening
Literatures screened (n = 7)
Literatures excluded (n = 0)
Eligibility
Full-text articles assessed for eligibility
(n = 7)
Full-text articles excluded, with reasons
(n = 0) Included
Studies included in qualitative synthesis
(n = 0)
Studies included in quantitative synthesis
(meta-analysis) (n = 7)
63
Appendix 2: Table of evidence Bibliographic citation
Study type
Patient characteristics
Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Sauls, 2002
RCT
study
-Cardiac patients in 2 ICU
and 3 postoperative units
with chest tubes inserted
-Ages: 21-85 years old
(Mean ages: 59.7 years
old)
Ice pack was applied to the
skin at either side of the chest
tubes, covering 38.7 cm² for
10 minutes
(n=25)
Tap water pack (30.6°C to
31.7°C) was applied to the
skin at either side of the chest
tubes, covering 38.7 cm² for
10 minutes
(n=25)
Not
mentioned
Primary:
(1) Pain & Distress in NRS:
(A) immediately after CTR
(B)10 minutes after CTR
(2) No. of quality descriptors
for pain
Secondary:
(3) Pain & Distress in NRS
10mins after packs application
(1) (A):
Pain: -0.48 (p>0.05)
Distress: +0.42 (p>0.05)
(1) (B):
Pain: -0.26 (p>0.05)
Distress: -0.1 (p>0.05)
(2) Both groups: 15
(3)Pain: +0.14 (p>0.05)
Distress: -0.1 (p>0.05)
Demir, 2010 RCT
study
-Cardiac patients in ICU
with 2-3 chest tubes
inserted
-Ages: 18-74 years old
(Mean ages: 53.4 years
old), BMI<30kg/m²
-10mg/kg paracetamol IV
was injected 60 minutes
before CTR (for all groups)
- A gel pack (+4°C) was
placed to the skin occupying
5cm³ surrounding chest tubes
for 20 minutes
(n=30)
Two comparison groups
(a) & (b):
(a) A gel pack (room
temperature) was placed to
the skin occupy 5cm³
surrounding chest tubes for
20 minutes (n=30)
(b) Nil packs being applied
(n=30)
Not
mentioned
Primary:
(1) Pain in VAS:
(A) immediately after CTR
(B) 15 minutes after CTR
(2) Anxiety score difference
(STAI-I) 15 minutes after CTR
Secondary:
(3) length of time (hours)
before requesting analgesics
after CTR
(1)(A)(a): -0.36 (in sig.)
(1)(A)(b): -0.46 (in sig.)
(1)(B)(a): -0.7 (in sig.)
(1)(B)(b): -0.7 (in sig.)
(2)(a): -3.21 (p>0.05)
(2)(b): -4.4 (p>0.05)
(3)(a): +0.3 (p<0.05)
(3)(b): +0.43 (p<0.05)
64
Bibliographic citation
Study type
Patient characteristics
Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Ertug, 2011
CT
study
-Thoracic surgery patients
in postoperative surgical
clinic with 1 chest tube
inserted
-Did not have CTR
experience
-Ages:18-65 years old
(Mean ages: 48.7 years
old)
-Ice pack covered 6.125 cm²
skin around the chest tube
before CTR
-Pack removed when reached
13°C (average time: 9 mins)
(n=70)
No ice pack application
before CTR
(n=70)
Not
mentioned
Primary:
(1) Pain in VAS:
(A) immediately after CTR
(B) 5 minutes after CTR
Secondary:
(2) 4 time points temperature
around the skin of the chest
tube in intervention group
(1)(A) -1.75 (p<0.05)
(1)(B) -0.38 (p<0.05)
(2)
1st data: 33.13°C
2nd data: 12.93°C
3rd data: 23.58°C
4th data: 29.59°C
(p<0.05)
Mazloum, 2012 RCT
study
-Cardiac patients in ICU
with 1 pericardial and 1
thoracic chest tube.
-Distance between the
tubes: 8-10cm.
-Mean ages: 56 years old.
Mean BMI: 25kg/m²
-Midazolam IV was given (for
all groups)
-Ice packs (0 -5°C) were bent
in half circle shape and being
applied around the skin of the
chest tube for 20 minutes
(n=34)
Comparison groups (a)&(b):
(a) Placebo packs
(18-22°C) were bent in half
circle shape and being
applied around the skin of the
chest tube for 20 minutes
(n=34)
(b) Nil packs being applied
(n=34)
Not
mentioned
Primary:
Pain in VAS:
(A) immediately after CTR
(B) 15 minutes after CTR
(A)(a) -1.7 (p<0.05)
(A)(b) -1.5 (p<0.05)
(B)(a) -1.4 (p<0.05)
(B)(b) -1.3 (p<0.05)
65
Bibliographic citation
Study type
Patient characteristics Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Otaibi, 2013 RCT
study
-CTS patients in surgical ward
and ICU with 1 or 2
mediastinal or pleural chest
tubes.
-Mean ages: 40.7 years old
-1gram perfalgan received 60
minutes before CTR (for all
groups)
-A soft ice gel pack was placed
around the skin of the chest
tube
-Gel pack removed when
reached 13°C
(n=20)
Placebo pack (room
temperature) being
applied (n=20)
Not
mentioned
Primary:
(A) Pain in VAS:
(B) Immediately after CTR
(C) 15 minutes after CTR
(2) HAM-A changes after CTR
Secondary:
(3) Correlation: Pre-CTR
anxiety VS pain level
15minutes after CTR
(4) Demographic
characteristics VS pain level
(1)(A) -5.95 (p<0.05)
(1)(B) -1.8 (p<0.05)
(2) -5.55 (in sig.)
(3) +0.0364 (p<0.05)
(4) Pain level:
-before CTR: p<0.05
–during CTR: p>0.05
-15 minutes after CTR:
p>0.05
Gorji, 2014 RCT
study
-Open heart CABG patients in
CCU with 1 left pleural and 1
mediastinal chest tubes
-Did not have CTR experience
-Mean BMI: 25.8kg/m². Mean
ages: 58.1 years old
-Acetaminophen pills received
every 6 hours (for all groups)
-3 cold gel packs (0°C) twisted
by gauze were placed to skin
surrounding chest tubes
-Packs removed when reached
13°C (mean time: 10 minutes)
(n=40)
Nil gel packs being
applied
(n=40)
Not
mentioned
Primary:
Pain in VAS:
(A) immediately after CTR
(B) 15 minutes after CTR
(A) -2.2 (p<0.05)
(B) -0.22 (p<0.05)
66
Bibliographic citation
Study type
Patient characteristics Intervention(s) Comparison Length of FU
Outcome measures Effect size Mean(IG – CG)
Mitra, 2014 RCT
study
-CABG or CABG with
valvular surgery patients in
ICU with pleural and
mediastinal chest tubes.
-Mean ages: 58.7 years old
-Indomethacin suppository of
dosage: 100mg received 1
hour before CTR (for all
groups)
-A cold gel pack (4 °C) was
applied to the skin
surrounding chest tube for 20
minutes before CTR
(n=32)
A gel pack (room
temperature) was applied
to the skin surrounding
chest tube for 20 minutes
before CTR
(n=34)
Not
mentioned
Primary:
Pain in VAS:
(A) Immediately after CTR
(B) 15 minutes after CTR
(A) -1.23 (p<0.05)
(B) -0.14 (p>0.05)
Abbreviations: 1: CTR= chest tube removal 6: in sig.= in significant 2: Length of FU= length of follow up, in months 7: RCT= randomised controlled trial 3: IG – CG= intervention group – comparison group 8: CCT= clinical controlled trial 4: NRS & VAS= numerical rating scale & visual analogue scale 9: HAM-A= Hamilton anxiety rating Both scales ranged from 0 to 10 scores, with 0 = the least severe, 10 =the most severe scale 5: STAI-I= Spielberger situational anxiety level inventory 10: CTS= cardiothoracic surgery (Larger negative value= more reduction in anxiety level)
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Appendix 3: Methodology checklist (Based on SIGN checklist related to controlled trials)
Sauls, 2002 article: 1: Internal Validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. As mentioned in the article, the participants were those aged from 21-85 years old with chest tubes inserted after cardiac surgery. In the intervention group, ice pack was placed at either side of the chest tube’s skin for 10 minutes before CTR. The comparison group was the application of tap water pack for 10 minutes before CTR. The primary outcomes of the study were the pain level and pain distress immediately and 10 minutes after CTR. The number of quality descriptors used for pain after CTR was another primary outcome. The secondary outcomes of this study were the pain and distress level 10 minutes after the application of packs before CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The Author only stated that the participants were randomly assigned into intervention and control groups, but did not mention the randomization method in details. 1.3: An adequate concealment method is used. Answer: No. There was no mention for the concealment methods for the researchers when assigning participants into groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Can’t say. As the presence of blinding for patients and investigators were not clearly mentioned.
68
1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The author stated that the demographic data of the participants such as the age, gender, ethnicity, primary diagnosis, type and number of chest tubes, previous cardiac surgery and previous chest tubes experience and type of postoperative pain medication were collected and mentioned that there were no significant differences between the intervention and comparison groups. However, the actual data for these demographic variables had not been listed in the article. 1.6: The only difference between groups is the treatment under investigation. Answer: No. As mentioned by the author, the investigator, which was the only nurse present during the intervention, might provided a chance for some of the participants to ask questions related to the treatment received. It was difficult for the investigator not to respond to their questions and extra information and explanations were provided by the investigator to some of the participants. Also, seven health care professionals with different level of expertise performed the CTR, the environmental nature of different sites might create extraneous variables for the participants. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The conclusion of this article based on primary outcomes. The primary outcomes of the study were to see whether the application of ice pack around the chest tubes for 10 minutes can significantly decreased the pain level and pain distress of the patients immediately and 10 minutes after CTR. Another primary outcome was to see whether fewer quality descriptors for pain would be used in the intervention group than the comparison group after CTR. The measurement tool for pain level and pain distress was numeric rating scale (NRS), which was supported by Puntillo (1994, 1996) & Puntillo & Weiss (1994), to effectively rate the procedural pain and distress of critically ill patients. The presence of reliability and construct validity for this NRS had also been supported by Downie et al. (1978), Jensen, Karoly & Braver (1986), Jensen, Karoly, O’Riordan, Bland & Burns (1989). The quality descriptors for pain listed in the McGill Pain Questionnaire-Short Form (MPQ-SF) were used. The presence of reliability and validity for MPQ-SF had been supported by Chapman et al. (1985), Wilke, Savedra, Holzemer, Tesler & Paul (1990).
69
1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: No participants dropped out from both intervention and control groups after being recruited. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants in both intervention and control groups completed the treatments assigned to them. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Can’t say. As the study carried out at different units (a surgical intensive care unit, a coronary intensive care unit, a medical intensive care unit and 2 acute postoperative units) in a teaching hospital, there were no reports given for the specific data of these sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of the study was rated unacceptable (reject 0). The main problem for this study was that the difference between the intervention and control groups was not only the treatments, but also the extra explanations and information provided by the investigator which might create some extraneous variables to the results. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It is not certain that the overall effect was due to the intervention. According to the results, there were no significant difference between the intervention and the control groups in pain level, distress level and the number of quality descriptors used for pain. From the methodological
70
aspect, the randomization method, the concealment method, the blinding method and the results for the specific site should be elaborated and reported in details. The major confounding variables should be the treatments offered to both the intervention and control groups. The inconsistency of the environment for different sites, the different expertise level of health care professionals in performing CTR and the extra information and explanations provided by the investigator for some of the participants might affected the final results. For the statistical power of the sample, there was nil information being mentioned. However, in view of 25 participants for both groups yielded non-significant difference results, sample size should be increased for future study to improve the statistical power. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The study intervention can be directly applied to the patients, as cold application method is cheap, safe to patients and easy to be applied. However, in view of the insignificant difference results between the intervention and control groups, it may not be considered by the health care professionals to implement this intervention. 2.4: Conclusion and comment for this article: According to the Author, pain consisted of distress component (affective) and sensory pain and they are correlated. Similar study should be done in the future, in which the ice pack application could be longer than 10 minutes to produce a desire effect, a larger sample sized is needed, dividing participants into 3 groups which contained intervention group, placebo group and those undergo usual treatment to rule out whether there were any effects for the placebo treatment. In the article, the tap water at the range of 30.6°C to 31.7°C might achieve some kind of cooling effect to the skin temperature in the control group, which might contribute to the non-significant difference results between the intervention and control groups. Furthermore, an effort to control extraneous variables, better randomization, concealment and blinding methods should be elaborated clearly in the future study to improve generalizability.
71
Demir, 2010 article: 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. The targeted patients in this study were those cardiac surgery patients aged 18-74 years old, BMI<30kg/m² and with 2 to 3 chest tubes inserted after operations in ICU. A standard dose of 10mg/kg paracetamol IV would be injected to all participants 60 minutes before CTR. For the intervention group, a cold gel pack (+4°C) wrapped with gauze would be bent and placed to the surrounding skin of chest tubes for 20 minutes before CTR. There were two comparison groups, the placebo and control groups. For the placebo group, a gel pack at room temperature wrapped with gauze would be bent and placed to the surrounding skin of chest tubes for 20 minutes before CTR. For the control group, nil gel pack would be applied. The primary outcomes of the study were pain intensity immediately and 15 minutes after CTR and anxiety level during CTR. The secondary outcome would be the length of time before the request for analgesics after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The authors only stated that a simple randomization method was used for assigning participants into groups. However, there was no mention about the randomization method in details. 1.3: An adequate concealment method is used. Answer: Can’t say. The authors only mentioned that some methods were used to prevent manipulation during assignment. However, no details about the methods were provided.
72
1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. As mentioned by the authors, the study participants were ‘blinded’ by the researcher and did not know which groups they were in. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors only stated that the demographic and clinical features of the participants in the three groups were similar and no significant differences, with P>0.05. A table listing the demographic and clinical features of the participants in each group should be provided for better understanding. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. The participants in each group received their treatments in standard way according to the group being assigned. All the chest tubes were removed by the same doctor. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The first primary outcome of this study was to determine whether the application of cold gel pack could significantly reduce the pain intensity immediately and 15 minutes after CTR. Another outcome was to determine whether the intervention could significantly reduce the anxiety level during CTR. The conclusions of this study based on the primary outcomes. The pain intensity was rated by vertical visual analog scale (VAS). The validity of VAS was supported by Puntillo (1994) for critically ill cardiovascular surgery patients. The anxiety level was measured by a tool called Spielberger Situational Anxiety level Inventory (STAI-I), the concurrent validity was supported by LaCompte & Oner (1976).
73
1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: No participants dropped out after being recruited. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable. The participants in the groups received their treatments according to the groups being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Not applicable as the study only conducted at the cardiovascular and thoracic surgical intensive care unit at Ege University Hospital. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of the study was rated acceptable (+). Most of the internal validity criteria are met for this study. Single blinding method was used and the treatments received by the participants were standard according to the group being assigned. However, the randomization and concealment methods should be elaborated more for better understanding. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It is quite certain that the overall effect is due to the intervention, but improvements should be considered. The intervention group had shown a significant reduction in pain intensity immediately and 15 minutes after CTR. In addition, it showed longer time for requesting analgesics after CTR when compared with the comparison groups. When viewing the methodology used for this study, according to Sauls (2002)
74
study, the use of 30.6°C to 31.7°C placebo bag to the group might actually provide a cooling effect to the skin of the placebo group. The placebo pack used in this study was at room temperature, which might reduce the cooling effect to the placebo group. In addition, single blinded method applied to the participants could reduce the bias arise in the study. Furthermore, the demographic data for both intervention and comparison groups were similar (P>0.05), each participant received treatments according to the group being assigned in a standard way increased the rigor of the study results. The tools for measurement were reliable and valid. Only 1 doctor performed CTR also ensured the reliability of the results. However, the authors should elaborate more about the randomization and concealment methods in order to have a better understanding of the study. For the statistical power, power analysis was performed to calculate the simple size, and the power was 81% (alpha <0.05) for the sample size which was adequate to show the effects of the intervention. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: Yes. The application of cold gel pack is simple, safe to patients and cheap which can be directly applied to the patients. It is worth for health care professionals to apply the intervention as this study had shown a significant reduction of pain intensity after CTR. 2.4: Conclusion and comment for this article: According to the study, the cold gel application could significantly reduce the pain intensity during CTR and prolong the time for requesting analgesics, but did not affect the anxiety level being felt by the participants. Participants’ emotions could be affected by the environment, such as the light, noise and the surrounding health care professionals. Furthermore, participants with different cultural backgrounds might affect their perceptions to pain and anxiety. Therefore, environmental factors should be well controlled by the researchers and the culture factor of the participants on pain and anxiety perception should be studied in the future research. Besides, placebo pack of temperature closed to the skin temperature of the participants should be used in order to reduce the cooling effect on the participants in the placebo group. Finally, although the cold gel application group showed a significant decrease in pain intensity during CTR, the VAS was still 6.77 immediately after CTR, which was moderate level in pain. Future studies should be consider to combine cold application method with other pharmacological methods or
75
non-pharmacological methods in order to help participants have a better pain control during CTR. Ertug, 2011 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. The authors had stated the characteristics of the participants: 18-65 years old with one chest tube and did not have previous CTR experience. Intervention group: ice pack being applied around the chest tube insertion site before CTR until the skin temperature reached 13°C. Comparison group: no ice pack application before CTR. The primary outcomes: the VAS score immediately and 5 minutes after CTR and the secondary outcome: the changes in skin temperature at 4 different time points for the intervention group. 1.2: The assignment of subjects to treatment groups is randomized. Answer: No. The participants were assigned to the intervention and control groups according to the time they were recruited. The participants recruited on the odd-dated days of the month would be arranged to intervention group while those recruited on the even-dated days would be arranged to control group. This study was a clinical controlled trial study instead of randomized controlled trial study. 1.3: An adequate concealment method is used. Answer: Not relevant as it was a clinical controlled trial study. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Not relevant as it was a clinical controlled trial study.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had mentioned the demographic data between the intervention and the control groups. The data included genders (P>0.05), ages (P> 0.05), indications for chest tube insertion (P>0.05) and chest tube insertion days (P< 0.05). Among all the data, only the chest tube insertion days had shown a significant difference but not others. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. The authors had mentioned that all the participants in the intervention group received the ice pack application while all the participants in the control group received nil treatment. Although different physicians were responsible for CTR for the participants, all the physicians followed the same guideline in performing CTR. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The primary outcomes were the pain score immediately and 5 minutes after CTR. The main conclusion was based on the primary outcomes. The primary outcomes (changes in patients’ pain level) were measured using the vertical VAS. According to Guzeldemir (1995) & Eti-Aslan (2002), VAS was a sensitive and reliable tools for reflecting pain score. In addition, Cline et al. (1992) & Guzeldemir (1995) pointed out that a vertical line based VAS was easily understood by the participants. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: The authors had mentioned that there were 5 participants in the intervention group and 4 participants in the control group dropped out from the study before the research began. The drop out rate was 7.14% for the intervention group and 5.71% for the control group and such loss was replaced by recruiting other participants. However, there were no reasons provided for the drop out.
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1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable. It was because all the participants in the intervention group had ice pack application before CTR and the participants in the control group had nil interventions before CTR. The chest tubes in both the intervention and control groups were removed finally. No missing values or dropped out participants noticed after the research began. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply. It was because the study was carried out in a surgery clinic in a thoracic hospital but not conducted in various sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: It was acceptable (+) in general speaking. The study met most of the criteria in the checklist. However, it could not be regarded as a randomized controlled trial study as the assignment of the participants to the groups based on time of recruitment but not randomization. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the primary outcomes of the study were due to cold application, but some improvements should be considered. In view of the methodology, the pain level of the participants was measured by using VAS, which was reliable and valid as discussed before. All participants received the intervention based on their group and had CTR according to standard protocol. There was no missing data found during the study. However, the assignment of the participants should be randomized instead of determined by the time they were recruited to reduce the demographic bias of the participants between the intervention and the control groups. Lucky, the demographic data between two groups were similar except the days for chest tube insertion. In view of the statistical power of the study, the sample size 140 was adequate since the power
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was calculated as 99%, which was greater than 0.8, for alpha=0.05, as this study contained 2 independent groups. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: This method was cheap, safe and easy to be applied. Therefore, cold application should be considered applying directly to the target patients. The cold application could significantly reduce the pain intensity of the participants immediately and 5 minutes after CTR in this study, which worth to be considered by the health care professionals. 2.4 Conclusion and comment for this article: According to the study, cold application as a non-pharmacological method applied prior to CTR could reduce the pain level immediately and 5 minutes after CTR. In this study, it supported the study result of Demir & Khorshid (2010), which shown a significant decreased in pain level for cold application group after CTR, but contradict with the study result found in Sauls (2002), which showed that cold application was not effective in reducing pain related to CTR. Moreover, this study only employed those with only 1 chest tube, which could not concluded the pain intensity experienced by those with 2 or more chest tubes. Therefore, further studies with a good randomization and concealment methods, larger sample size and recruited those with 2 or more chest tubes in order to increase the generalizability of the result. Mazloum, 2012 article: 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. As mentioned in the article, the participants were those underwent cardiac surgery with mean ages 56 years old, mean BMI=25kg/m² and had one pericardial and one thoracic chest tubes. Participants in both groups had been prescribed midazolam IV before CTR.
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In the intervention group, ice packs of temperature 0-5°C wrapped by cotton clothes would be applied to the skin area surrounding the chest tube for 20 minutes before CTR. There were 2 comparison groups, which were the placebo and the control groups. In the placebo group, packs of temperature 18-22°C wrapped by cotton clothes would be applied to the skin area surrounding the chest tube for 20 minutes before CTR. For the control group, no packs would be applied before CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Yes. The authors stated that the assignment of participants to the groups was randomized. This was a crossover study in which each chest tube in each patient would be assigned for 1 treatment. There were 3 groups in this study, which were the cold application-control group, the cold application-placebo group and the placebo-control group. 3 cards with codes for these 3 groups would be drawn out by the researchers randomly. For example, if a card coded for cold application-control group was drawn, one chest tube would receive ice pack treatment while the other chest tube would not receive any packs for that participant. 1.3: An adequate concealment method is used. Answer: No. The authors did not state any methods for concealment when assigning participants into groups. There was no mention whether the researchers knew the sequence of the cards which were used for assigning participants into different groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. This study was a single blinded study in which the participants were ‘blinded’ and did not notice whether they were assigned into intervention or comparison groups. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had stated some of the baseline characteristics among the 3 groups, which were the mean ages (P>0.05), mean BMI
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(P>0.05), baseline body temperatures (P>0.05) and the fatigue scores before the study (P>0.05). All of these data were statistically insignificant. However, more data among the participants should be reported such as the genders of participants in each group, nationality etc. 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants in each group received the same treatments according to the groups being assigned. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The results of the study based on the primary outcomes, which were the pain level immediately and 15 minutes after CTR. The reliability and validity of the VAS for pain level measurement was confirmed by Gift (1989) & Lee (1991). 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: Not applicable as there was no participants dropped out before the study completed. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants in each group completed all the treatments being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Not applicable as the study only conducted at the ICU in Imanm Reza Hospital of Mashhad but not others.
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2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: This study was rated acceptable (+). It was a randomized, single blinded study in which the study participants did not notice which groups they were in. However, a clear concealment method should be stated related to the assignment of participants into different groups. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was certain that the study results were due to the cold application applied in the intervention group, but improvements should be considered. The pain levels of the participants in the intervention group immediately and 15 minutes after CTR were significantly lower than those of the placebo and the control groups. In view of the methodology of the study, a randomization method was listed out clearly, single blinded method was used so that the participants did not aware which group they were in and there were no significant differences in demographic data among the three groups before the study. However, the details for concealment method in assigning participants to the three groups were not stated clearly. There was no mention on how to prevent the researchers from knowing the sequence or codes of the cards when drawing them. In addition, more demographic data such as genders of the participants in each group, nationality etc. should be reported to minimize bias. When viewing the statistical power of the sample, no power analysis being mentioned. In this study, 34 chest tubes were allocated in each group, which were larger in sample size when compared with Demir (2010) study, in which the power of the sample in Demir (2010) study was 81%. Therefore, the samples size in this study was adequate to reflect the effect of cold application on pain level during CTR. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: Yes. The results of this study showed that the cold application group had significantly reduced the pain level immediately and 15 minutes after CTR when compared with the placebo and the control groups. The application of ice pack around the skin of the chest tubes sites
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was easy, cheap and safe to the patients. It was worth for the health care professionals to consider applying the cold application method to the targeted patients. 2.4: Conclusion and comment for this article: According to the authors, applying ice packs around the skin of the chest tubes sites were easy, cheap and safe method to reduce pain level of the patients during CTR. This study supported the result of Demir (2010) study but contradicted with Sauls (2002) study. The difference of results for this study when compared with Sauls (2002) might due to the longer cold application time being used. This study was a cross-over design, in which each participant act as both intervention and comparison groups at the same time. The advantage for this design is that since the intervention group and the comparison group are conducted in the same person, the baseline difference can be eliminated. However, the disadvantage for this design is the ‘carry over’ effect. The result of the latter group may be due to the carry over effect of the previous group. Although there was a ‘washing period’, in which the time between the CTR of the two chest tubes was 30 minutes, it was difficult to determine whether 30 minutes was enough to eliminate the effect of the previous treatment on the participant. Therefore, if similar cross-over design study will be conducted in the future, the length of the washing period should be investigated so that the effect of the previous treatment can be eliminated before conducting the latter treatment. Otaibi, 2013 article: 1: Internal Validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. According to the study, the participants were those cardiothoracic surgery patients with 1 or 2 mediastinal or pleural chest tubes inserted, mean ages were 40.7 years old. All the participants would receive 1 gram perfalgan 60 minutes before CTR. In the intervention group, a
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soft ice pack gel would be placed on top of a sterile gauze pad surrounding the skin of the chest tube until the skin temperature reached 13°C. For the comparison group, placebo pack at room temperature was applied. The primary outcomes were the pain level during and 15 minutes after CTR and also the anxiety level after CTR. The secondary outcome were the correlation between pre-CTR anxiety and pain level 15 minutes after CTR and also the correlation between the demographic characteristics of the participants and the pain level before, during and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. It was because the authors only stated that this study was a randomized study, but did not mention any randomization methods. 1.3: An adequate concealment method is used. Answer: No. As there was no mention about any concealment methods used to prevent researches from knowing the assigning sequence of participants into different groups. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. As mentioned by the authors, it was a single blinded study in which the participants were not known which groups they were in. 1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The authors had listed the demographic and baseline characteristics of the participants before the study, such as the gender of each group (P>0.05), the mean ages of each group (P>0.05), the insertion duration of the chest tubes of each group (P>0.05) and also the pain intensity of each group before CTR (P<0.05). Only the pain intensity before CTR of the two groups showed a significant difference but not other characteristics.
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1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants received the same treatments corresponding to the groups being assigned. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Can’t say. The conclusion of the study was based on the primary outcomes, which were the pain level during and 15 minutes after CTR and also the anxiety level after CTR. The tool used for rating pain level was VAS and the tool used for rating anxiety level was Hamilton Anxiety Scale. No mention about the reliability and validity of the tools being mentioned in the article. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Answer: Not applicable as there were no participants from each group dropped out before the study was completed. 1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Not applicable as all the participants completed all the treatments corresponding to the group being assigned. 1.10: where the study is carried out at more than one site, results are comparable for all sites. Answer: Can’t say. The study was conducted in the cardiothoracic surgical ward and also the intensive care unit of King Fahd Hospital. However, no specific data was provided for each site.
2: Overall assessment of the study: 2.1: How well was the study done to minimize bias?
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Answer: The quality of this study was rated acceptable (+). Single blinding method was used to the participants which could reduce bias to the treatments being applied. However, a clear randomization and concealment methods in assigning participants to different groups should be stated clearly. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the results were due to the cold application being applied to the participants in the intervention group, but improvements should be considered. The results showed that the pain level was significantly reduced immediately and 15 minutes after CTR in the intervention group when compared with the placebo group. In addition, the anxiety level of the participants in intervention group was significantly lower than those in control group after CTR. In view of the methodology, randomization was mentioned by the authors in assigning patients into two groups. The demographic and baseline characteristics of the participants were similar between the two groups and all the participants received the treatments corresponding to the groups being assigned which could help reduce bias to the study. However, a clear randomization and concealment method should be clearly stated in assigning participants into different groups. Furthermore, the reliability and the validity of the tools used for rating pain and anxiety level, the VAS and the Hamilton Anxiety Scale respectively, should be assessed before using for measurements. Finally, the pain level before CTR for intervention group was significantly higher than those of the control group. The baseline characteristic of the participants should be similar to reduce bias. In view of the statistical power of the sample, there was no mention about the power of the sample size. However, in view of the previous similar studies, 40 participants were not enough to generalize the results to other similar patients. More participants should be recruited in the future studies.
2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The results of this study could be directly applied to the target patients. In this study, the pain level was significantly reduced immediately and 15 minutes after CTR in intervention group when compared with placebo group. In addition, the anxiety level was also
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significantly lower in the intervention group than those in the control group after CTR. Therefore, it was worth for the health care professionals to consider applying the cold application method to the targeted patients. Moreover, the soft icepack gel was cheap and safe for applying to patients. 2.4: Conclusion and comment for this article: According to the authors, cold application was effective in reducing pain level immediately and 15 minutes after CTR. It could also reduce the anxiety level of the patients after CTR. In view of the secondary outcomes, the pre-anxiety level of the participants in both groups significantly correlated with the pain level after CTR, which supported the previous thought that the anxiety level might affect the perception of pain. The demographic characteristics of the participants significantly affected the pain level perceived before CTR, but not pain level during and 15 minutes after CTR as shown in this study. This is an interesting point as the targeted patients may have different demographic characteristics such as different ethnicity or religious belief. Some patients may particularly fear to pain while some are not. However, due to the small sample size for this study, the results cannot be effectively generalized to others. Future studies with a greater sample size should be conducted to investigate these effects on pain level being perceived by the patients. Gorji, 2014 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question.
Answer: Yes. The study clearly stated the participants, intervention, comparison group and outcomes. The characteristics of participants were those with mean ages 58.1 years old, did not have the experience of CTR before and had 2 chest drains. The study contained 3 groups, which were the cold application, relaxation and control groups. Due to the translational research topic interest, only the results of cold application and
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control groups were considered here. Participants in all groups received oral acetaminophen every 6 hours. In intervnetion group, 3 cold gel packs twisted by gauze of 0°C was placed on the skin surrounding the chest tubes until the skin temperature reached 13°C (average time=10 minutes) as measured by infrared temperature before CTR. For control group, there was no gel pack being applied to the participants. The outcomes were the comparison of VAS scores among the groups immediately and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Yes. The author stated that the participants were assigned randomly to the intervention and control groups by using the Excel programme in the computer to generate random number to the participants. For the participants in the intervention group, each of the 2 chest tubes for each participant would have individual assignment. The participants would be divided into 7 bulks with 6 participants in each bulk. 3 cards with codes indicated left pleural cold-mediastinal relaxation treatments while 3 cards with codes indicated left pleural relaxation-mediastinal cold therapy would be randomly selected for the chest tubes. As a result, each of the 2 chest tubes for the patients in the intervention group would receive cold application or relaxation treatment according to the card being drawn. 1.3: An adequate concealment method is used. Answer: Can’t say. The author stated that the assignment of the participants into groups by Excel software in the computer, but did not mention whether the researchers knew the sequence and codes on the cards which were used for allocating chest tubes into different treatments in the intervention group.
1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. The author had stated that this was a single and observer-blinded study. A nurse was trained to record VAS and was responsible for recording the pain level for different groups. The nurse was ‘blinded’ for different treatments applied before CTR.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The author had presented the baseline characteristics of the participants before conducting the study. The characteristics were the age (P>0.05), the body mass index (P>0.05), the chest tubes remaining time after operation (P>0.05), the sex (same number of males and females for both experimental and control groups), the education level (P>0.05), the occupation (P>0.05) and their living geographical positions (P>0.05). All of these characteristics were not significant in difference between the intervention and control groups. In addition, there were no significant difference in pain level between the cold application and control groups before CTR (P>0.05). 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All the participants received acetaminophen tablets every 6 hours and received the treatments according to the groups being assigned. Also, the chest tubes in different groups were removed by the same nurse and the VAS score in different intervals were also recorded by the same nurse for all groups. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The primary outcomes in this study were the pain level for the participants immediately and 15 minutes after CTR and the conclusion of this study based on the primary outcomes. The pain level of the participants was measured by using VAS. Both the reliability and validity of this tool for rating the pain level of CABG patients were supported by van Valen et al. (2012).
1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before study was completed. Answer: Not applicable as there was no drop out of participants during the study.
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1.9: All subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis). Answer: Does not apply as all the participants had received all the treatments according to the group being assigned. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply as the study was done in Mazandaran Heart Centre only but not multiple sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: The quality of this study was acceptable (+). Most of the criteria listed in the checklist were followed, with a good randomization method and as a single blinded study. However, the concealment methods for assigning patients into different intervention groups were not clearly mentioned. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the results were related to the cold application applied to the surrounding skin of the chest tubes, but improvements should be considered. The pain levels of the cold application group were significantly lesser than the control group immediately and 15 minutes after CTR. In view of the methodology, it was an observer- blinded, randomized controlled study with a good randomization
method by using Excel programme for assigning participants into interventions and control groups. However, the concealment method was not clearly stated, which might create bias to the results. In addition, for the intervention group, each participant needed to undergo two different treatments for the two chest tubes (Relaxation VS Cold application). The pain level result of the relaxation group might not directly related to the
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relaxation treatment since the cold application was applied to one of the chest tube first before proceeding relaxation treatment to another chest tube (carry over effect). Luckily, the cold application group was the main interest in this translational research but not the relaxation group. The baseline characteristics between the intervention and the control groups were similar, which could reduce the bias towards the results. In view of the statistical power, the power for sample size was 0.99. The sample size for this study was adequate to demonstrate the effect of cold application to pain level of the participants after CTR. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The result of this study can be directly applicable to the target patients undergoing CTR. In this study, the cold application had shown a significant reduction in pain level immediately and 15 minutes after CTR when compared with the control group. The cold packs used for the cold application group were cheap and not causing harm to patients. Due to these factors, cold application method was worth for the health care professionals to consider by applying to the target patients to relieve their pain. 2.4: Conclusion and comment for this article: The Author stated that the cold application was worth to be considered during CTR in view of the significant reduction in pain level in the intervention group when compared with the control group. The cold packs used in this study could be easily bent and cover the skin surrounding the chest tube, which could provide a better cooling effect to the skin. This may be the reason to explain why the study results different from that of the results in Sauls (2002). However, this study only focused on pleural and mediastinal chest tubes but not other chest tubes. To increase the generalizability of the study results, CTR to different sites of the chest with a bigger sample size should be studied in the future. Moreover, as the relaxation treatment group also shown a significant reduction in pain level immediately and 15 minutes after CTR when compared with the
control group, future studies can consider to investigate the combine effect of relaxation and cold application on pain level during and after CTR.
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Mitra, 2014 article 1: Internal validity: 1.1: The study addresses an appropriate and clearly focused question. Answer: Yes. This study clearly stated the target participants: postoperative CABG or CABG with vavular surgery patients with mean ages of 58.7 years old with mediastinal and pleural chest tubes. The study divided into intervention and placebo groups. Participants in both groups will receive 100mg Indomethacin suppository one hour before CTR. In intervention group, a cold gel pack of temperature 4 °C was applied on the skin surrounding the chest tube site for 20 minutes before CTR. In Placebo group, a gel pack of room temperature was applied around the skin of the chest tube site for 20 minutes before CTR. The primary outcomes were pain level in terms of VAS immediately and 15 minutes after CTR. 1.2: The assignment of subjects to treatment groups is randomized. Answer: Can’t say. The authors only stated that the participants were randomly assigned to the intervention and placebo groups, but no clear randomized method being mentioned. 1.3: An adequate concealment method is used. Answer: No. There was no mention about whether the researchers knew the allocation sequence or not. No concealment methods being reported. 1.4: Subjects and investigators are kept ‘blind’ about treatment allocation. Answer: Yes. The author had mentioned that this is a single-blinded study in which the participants did not know whether they were in intervention or placebo group throughout the study.
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1.5: The treatment and control groups are similar at the start of the trial. Answer: Yes. The baseline characteristics between the intervention and control groups were listed in a table such as genders (P>0.05), Ages (P>0.05), length of the chest tubes (P>0.05), weight (P>0.05), BMI (P<0.05), type of surgery (P>0.05), type of analgesic used (P>0.05), Graft number (P>0.05), chest tube diameter (P>0.05), vital sign (P>0.05). Among these data, only the BMI showed a statistical difference between the two groups (P<0.05). 1.6: The only difference between groups is the treatment under investigation. Answer: Yes. All participants received 100mg indomethacin suppository 1 hour before the CTR. The chest tube was removed by the same health care professional for all the participants. The only difference was that the intervention group received the 4 °C cold gel pack for 20 minutes before CTR while those in the placebo group received the gel pack for 20 minutes at room temperature before CTR. 1.7: All relevant outcomes are measured in a standard, valid and reliable way. Answer: Yes. The conclusion of this study was based on its primary outcomes, which were the pain levels of the participants in different groups immediately and 15 minutes after CTR. The outcomes were measured by using VAS. Reliability and content validity were confirmed by the Zanjan University of Medical Sciences health related committee. 1.8: What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed. Answer: The author had mentioned that there were 2 participants dropped out in the intervention group. The drop out percentage was 5.88% in the intervention group (Total drop out percentage: 3.03%). These 2 patients withdrew because they had respiratory problems during the study.
1.9: All the subjects are analysed in the groups to which they were randomly allocated (often referred to as an intention to treat analysis).
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Answer: No. There was no mention about using intention to treat analysis in analyzing the 2 dropped out participants in the intervention group. 1.10: Where the study is carried out at more than one site, results are comparable for all sites. Answer: Does not apply. As the participants were recruited and conducted in the ICU of Alinasab hospital but not other sites. 2: Overall assessment of the study: 2.1: How well was the study done to minimize bias? Answer: It was acceptable (+). It was a single blinded study by blinding the participants so that they were not alert whether they were in the intervention or control group. However, the randomization method and concealment method were not clearly stated in this study. 2.2: Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? Answer: It was quite certain that the results of the study were due to the application of cold in the intervention group, but improvement of the study needed to be considered. The pain level of the intervention group was significantly lower than those of the placebo group immediately and 15 minutes after CTR. In view of the methodology of the study, randomization was mentioned in assigning participants into different groups. The baseline characteristics for the participants in two groups were similar except BMI. Single blinding method was used to blind the participants so that they were not aware which group they were in. The cold application time was 20 minutes in the intervention group, which provided enough time to cool down the skin to exert the analgesic effect. The only differences between the two groups were only the cold pack and the placebo pack in the intervention and control groups respectively. These measures help reduce biases to the study. However, a clear randomization and concealment methods should be mentioned clearly in assigning participants into different groups. In addition, an intention-to-treat analysis should be done to investigate the effects to the 2 dropped out participants. In view of the statistical power of the study, power of the samples was not mentioned. However, in view of only 68 participants in total, it was not adequate. To demonstrate a medium effect
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size (p<0.05) and a power of 0.8, 128 participants in total should be needed. 2.3: Are the results of this study directly applicable to the patient group targeted by this guideline? Answer: The results could be directly applicable to the target patient group. It was because this study had produced a significant reduction in pain level immediately and 15 minutes after CTR when cold pack was applied before CTR. Cold application was a safe, cheap and easy to be learnt by the health care professionals. It was worth for them to consider applying the cold application method to the patients before CTR to reduce patients’ pain. 2.4: Conclusion and comment for this article: According to the authors in this study, cold application method was worth to be used to the patients before CTR to relieve pain during this procedure. However, the samples for this study were small which might not be enough to demonstrate the true effects of cold application. Also, cultural differences and anxiety level of the participants were not studied in this study, which might affect the perception of pain by the participants. Therefore, future study should include these factors to conclude their effects on pain perception by the participants.
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Appendix 4
Comparisons between patients in local and literatures settings:
Patient characteristics Local setting Literature settings
Age ranges (years old) 20-70 18-85
Main type of CTS
performed
Lobectomy and
pneumoectomy
Lobectomy and CABG
Location of chest tubes Pleural Pleural, mediastinal and
pericardial
Setting in performing
CTR
Postoperative surgical
ward
Postoperative surgical
ward and clinic, ICU and
CCU
Preparations before
CTR
Prescribe analgesics just
before CTR
Prescribe analgesics 1
hour before CTR together
with cold application or
cold application alone
Nationality China United States, Iran,
Turkey and Saudi Arabia
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Appendix 5
Pain chart and VAS
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Visual Analogue Scale (VAS):
Using a vertical line, please mark your current level of pain on the 10 cm line
below. The pain level of the patient is determined by measuring the length from
no pain (0 cm) to the point in which the patient has marked.
No pain Extreme pain
Sources:
Pain chart: New Territories West Cluster (2008). Acute pain assessment chart. Hong
Kong: Hospital Authority.
VAS: Kahl, C., & Cleland J.A. (2005). Visual analogue scale, numeric pain rating
scale and the McGilll pain questionnaire: An overview of psychometric properties.
Physical Therapy Reviews, 10, 123-128.
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Appendix 6
Costs for implementing cold application versus usual practice in local setting per year (assume 240
patients undergoing CTR per year)
Preparation items Set-up costs for new programme
(in HK dollars)
Operational costs for new
programme (in HK dollars)
Costs for usual practice (in HK
dollars)
Trainer costs 900(i) 0 0
Silica gel cold packs 0(ii) 120 0
Refrigerator with digital
thermometer
0(ii) 0 0
Dressing pads 0(ii) 408(iii) 0
Mefix 0(ii) 1200(iii) 0
Hourmeters 0(ii) 100(iii) 100
Poster for guideline 130 0 0
New pain assessment form (iv) 12.5 137.5 0
Additional Nursing manpower 4800(v) 48000(vi) 0
Analgesics used 310(vii) 3414 5760(viii)
Antibiotics used (ix) 2400 26400 40320
Hospitalization costs (x) 4860000 6804000
Total 4948332 (T1) 6850180 (T2)
Benefits = T2-T1 6850180-4948332 = 1901848
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Footnotes:
(i): Assumed the senior physiotherapist invited has 10 years working experience and
with hourly rate = $300.
(ii): These items are already present before implementation of the new programme.
(iii): Assumed 2 additional dressing pads per patient, 1 additional box of mefix per
month and 2 additional hourmeters are needed per year for patients undergoing
CTR.
(iv): Assumed the minimum number of new pain assessment forms = 25 pages per
month and photocopying cost to be $0.5 per page.
(v): Assumed the nurses recruited have average 5 years working experience and with
hourly rate = $200.
(vi): Assumed 1 nurse is needed to spend 1 hour in preparing 1 patient undergoing
CTR.
(vii): Assumed 1 patient will take 2 tablets of panadol every 6 hours for duration of 1
day, each tablet costs around $1.9.
(viii): Assumed 1 patient will take 2 MST continus per day for duration of 1 day,
each tablet costs around $12.
(ix): Assumed average length of stay of each patient receiving new programme is 5
days while those receiving the usual practice is 7 days. IV Augmentin is used as an
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antibiotic after CTS and being injected 3 doses per day, each ampoule costs $8.
(x): Assumed average length of stay of each patient receiving new programme is 5
days while those receiving the usual practice is 7 days. According to Hospital
Authority press releases about service costs of hospitals (2012), the costs for an
in-patient bed is $4050 per day for 1 patient.
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Appendix 7: Level of the statements and grades of recommendations (SIGN, 2012) Level of evidence
Level of evidence Evidence statements 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low
risk of bias. 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias. 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias.
2++ High quality systematic reviews of case control or cohort or studies. High quality case control or cohort studies with a very low risk of confounding or bias and a
high probability that the relationship is causal. 2+ Well-conducted case control or cohort studies with a low risk of confounding or
bias and a moderate probability that the relationship is causal. 2- Case control or cohort studies with a high risk of confounding or bias and a
significant risk that the relationship is not causal. 3 Non-analytic studies, e.g. case reports, case series. 4 Expert opinion Grades of recommendations
Grade Statements A At least one meta-analysis, systematic review, or RCT
rated as 1++, and directly applicable to the target population; or a body of evidence consisting
principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall
consistency of results. B A body of evidence including studies rated as 2++,
directly applicable to the target population, and demonstrating overall consistency of results; or
extrapolated evidence from studies rated as 1++ or 1+. C A body of evidence including studies rated as 2+,
directly applicable to the target population and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 2++.
D Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+.
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Appendix 8: Evidence based guideline and recommendations
Guideline title:
Cold application programme in reducing procedural pain due to CTR
Objectives:
The aim of this guideline is to relieve the procedural pain suffered by the CTS
patients during CTR. The guideline can help:
1: pick up appropriate CTS patients who are going to undergo CTR,
2: standardize the pain relief preparations before CTR,
3: serve as a revision material for those new comers who are not familiar CTR pain
control.
Target populations:
This guideline is intended to all the nurses who are going to provide pain relief
preparations for the CTS patients before CTR procedure in a local postoperative
surgical unit. The inclusion and exclusion criteria of the patients are shown below.
Inclusion criteria:
1: Patients with ages 20 or above.
2: Patients oriented to time, place and person.
3: CTS patients with at least one chest tube or above undergoing CTR.
4: Able to understand and rate pain level by using VAS.
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Exclusion criteria:
1: Patients who are having psychiatric diseases or dementia.
2: Patients who are having poor visual acuity or blinded.
3: Patients who are oversensitive to cold and allergic to panadol.
Recommendations grading:
(1): VAS is an appropriate tool for assessing patient’s pain level during CTR. (Grade
of recommendation: B)
Evidence: VAS provides a continuum for patients to rate their pain level and easily
being understood by them. It also showed high reliability and validity in assessing
patient’s pain level. [Bijur, Latimer & Gallagher, 2003(2+); Tamiya et al., 2002(2++);
Williams, Davies & Chadury, 2000(4)]
(2): Cold application together with less potent analgesics can effectively reduce CTR
procedural pain suffered by the patients. (Grade of recommendation: A)
Evidence: Cold application has been shown to be effective in providing local
anesthesia around the application area, limiting the inflammatory process, reducing
the request for opioid analgesics and reducing the transmission of the pain impulses
to the brain, which was supported by Gate Control Theory (Melzack & Wall’s, 1965).
The studies of Gorji et al. (2014) and Mitra et al. (2014) with cold application plus
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less potent analgesics administered had been shown significantly reduced in pain
level by -2.2 and 1.23 respectively (p<0.05) when compared with the control group
immediately after CTR. [Barber, McGuire & Click, 1998(1+); Bleakley,
McDonough & MacAuley, 2006(1+); Koc, Yoldas, Dizen & Gocmen, 2006(1+);
Modabber et al., 2013(1+); Sarifakioglu & Sarifakioglu, 2004(1+)]
(3): Silica gel cold packs are more effective in providing cooling effect than ice
packs. (Grade of recommendation: A)
Evidence: Silica gel cold packs are more flexible and easier to be bent than ice
packs in order to provide effective cooling around the chest tube. Similar study by
comparing the cooling effect of cold gel packs and ice packs had been conducted in
applying to postoperative episiotomy wound. Patients with cold gel pads being
applied had significant lower pain level when compared those with ice packs being
applied (p=0.003). [Gorji et al., 2014(3); Zahra et al., 2008(1+)]
(4): The duration for cold application and temperature should be 20 minutes and
around 0-5°C in order to provide adequate analgesic effects to the patients. (Grade
of recommendation: A)
Evidence: Adequate cold application time and low temperature of the cold gel packs
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are important to provide effective cooling to patient’s skin and thus the analgesic
effects. In Sauls (2002) study, the cold application time was 10 minutes, which
showed a non-significant result in pain reduction in the intervention group. Studies
later had prolonged the cold application time to 20 minutes or used patient’s skin
temperature as an indicator for cold application time. Significant results were
yielded after this amendment. [Demir & Khorshid, 2010(1+); Ertug & Ulker,
2011(1+); Gorji et al., 2014(1+); Mazloum et al., 2012(1+); Mitra et al., 2014(1+);
Otaibi et al., 2013(1+); Sauls, 2002(1+)]
(5): The analgesic effects of cold application can be evaluated by VAS and mean
length of time before request for analgesics after CTR. (Grade of recommendation:
A)
Evidence: VAS had been shown to have high stability and reliability to assess
patient’s level as mentioned in statement 1. In Demir & Khorshid (2010) study, the
mean length of time in hours for patients in the cold application intervention group
was 0.3 and 0.43 hours longer than placebo and control groups respectively in
requesting analgesics after CTR (p<0.05), which can act as another indicator to
evaluate the analgesic effects of cold application. [Demir and Khorshid, 2010(1+)]
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Appendix 9: Cold application programme for CTS patients before CTR checklist
Patients are not applicable for this programme if they are: Unit/Dept: 1: having psychiatric diseases or dementia. Date: 2: are having poor visual acuity or blinded. 3: are oversensitive to cold and allergic to panadol.
Procedures Yes No Remarks
1 Administer 1 gram p.o. Panadol according to MAR chart after receiving doctor’s call (1 hour before CTR) and every 6 hours for
one day.
2 Apply silica cold gel packs of +4°C wrapped by dressing pads surrounding the chest tubes and anchored by mefix for 20 minutes
(counted by hourmeter) before CTR at bedside.
3 Transport patient to treatment room and position well for CTR. 4 Record patient’s pain level before CTR by using VAS in pain chart. 5 Remove the cold packs and assist doctor to perform CTR. 6 Perform pressure dressing to old drain site and record patient’s pain
level by using VAS in pain chart immediately after CTR.
7 Record patient’s pain level by using VAS in pain chart 15 minutes after CTR.
8 Record the time and pain level in pain chart each time patient requests for analgesics after CTR.
Remarks: 1: Please put a tick to ‘Yes’ column after completing a procedure before moving on to another procedure. 2: Please put a tick to ‘No’ column if the procedure is not done. Withdraw the programme and record the reasons of fail to complete the procedure in ‘Remarks’ column. 3: Please inform the corresponding CTS doctors if patient withdraw the programme due to serious responses. Doctors may need to assess the patient again to determine whether continue the CTR procedure or suspend it. Nurse for implementing the programme: Name: Signage:
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Appendix 10: Time table for implementation
Workflow Time (Month)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Preparations for presenting programme information to nursing
colleagues in ward meeting
Seek approval from DOM and COS
Forming working group for programme planning and refinement
Prepare posters and send email for promotion
4 RN receive cold application training by senior physiotherapist
before pilot study
Conduct pilot study
Evaluate and amend the protocol based on pilot study results
Training sessions provided by senior physiotherapist and working
group members to all RN
Full implementation of cold application programme
Evaluate patient’s data
Receive feedbacks from involved staffs and evaluate resources
arrangement
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Appendix 11: Integrated Progress Note (For intervention group)
CTS cold application programme progress notes
Patient’s code number: Date & type of surgery: Date of CTR: Drug allergy:
Before CTR Immediately after CTR 15 minutes after CTR Pain score (in VAS)
Number of times for requesting
analgesics Time for additional
analgesics required after CTR
Pain score (in VAS) when requesting for additional
analgesics 1st time 2nd time 3rd time 4th time 5th time
Incidents noticed during the programme (if any): Patient’s comments about the programme:
Please stick patient’s gum label here
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Appendix 12: Integrated Progress Note (For control group)
CTR progress notes
Patient’s code number: Date & type of surgery: Date of CTR: Drug allergy:
Before CTR Immediately after CTR 15 minutes after CTR Pain score (in VAS)
Number of times for requesting
analgesics Time for additional
analgesics required after CTR
Pain score (in VAS) when requesting for additional
analgesics 1st time 2nd time 3rd time 4th time 5th time
Incidents noticed during the procedure (if any): Patient’s comments about the procedure:
Please stick patient’s gum label here
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