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Evaluation of the effect of Benson’s relaxation technique on pain and quality of life of haemodialysis patients: A randomized controlled trial Masoume Rambod a, *, Farkhondeh Sharif b , Nasrin Pourali-Mohammadi c , Nilofar Pasyar d , Forough Rafii e a Community Based Psychiatric Care Research Center, Student Research Committee, Department of Medical Surgical, School of Nursing and Midwifery, Shiraz University of Medical Science, Shiraz, Iran b Community Based Psychiatric Care Research Center, Department of Mental Health and Psychiatric Nursing, Faculty of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran c School of Nursing and Midwifery, Shiraz University of Medical Science, Shiraz, Iran d Department of Medical Surgical, Faculty of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran e Center for Nursing Care Research, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran International Journal of Nursing Studies xxx (2013) xxx–xxx A R T I C L E I N F O Article history: Received 11 July 2013 Received in revised form 11 November 2013 Accepted 14 November 2013 Keywords: Haemodialysis Quality of life Relaxation therapy Pain A B S T R A C T Background: Haemodialysis patients may suffer from pain and impairment of quality of life. Some complementary interventions, such as relaxation therapy, might affect the pain and quality of life. The present study aimed to identify the effectiveness of Benson’s relaxation technique in relieving pain and improving the quality of life in haemodialysis patients. Study design: The study was a randomized controlled trial. Setting and participants: The data were collected in two haemodialysis units affiliated to Shiraz University of Medical Sciences. A total of 86 haemodialysis patients were randomly assigned to either the intervention (receiving Benson’s relaxation technique) or the control group (routine care) from 2011 to 2012. Intervention: The patients in the intervention groups listened to the audiotape of relaxation technique twice a day each time for 20 min for eight weeks. Measurements and outcomes: The pain numeric rating scale and Ferrans and Powers Quality of Life Index-dialysis version questionnaire were completed at baseline and 8 weeks after the intervention. The data were analyzed using independent t-test and ANCOVA. Results: The results of ANCOVA showed a significant difference between the intervention and the control group concerning the mean score of the intensity of pain (F = 6.03, p = 0.01). Moreover, a significant difference was found between the intervention and the control group regarding the total quality of life (F = 10.20, p = 0.002) and health-functioning (F = 8.64, p = 0.004), socioeconomic (F = 12.45, p = 0.001), and family (F = 8.52, p = 0.005) subscales of quality of life. Conclusion: These findings indicated that Benson’s relaxation technique might relieve the intensity of pain and improve the quality of life in haemodialysis patients. Thus, Benson’s relaxation technique could be used as part of the care practice for relieving the pain intensity and improvement of the quality of life in haemodialysis patients. ß 2013 Elsevier Ltd. All rights reserved. * Corresponding author at: School of Nursing and Midwifery, Shiraz University of Medical Sciences, Zand St., Namazee Sq., 7193613119 Shiraz, Iran. Tel.: +98 711 6474258; fax: +98 711 6474252. E-mail addresses: [email protected] (M. Rambod), [email protected] (F. Sharif), [email protected] (N. Pourali-Mohammadi), [email protected] (N. Pasyar), foroughrafi[email protected] (F. Rafii). G Model NS-2319; No. of Pages 10 Please cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on pain and quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/ 10.1016/j.ijnurstu.2013.11.004 Contents lists available at ScienceDirect International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns 0020-7489/$ see front matter ß 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijnurstu.2013.11.004

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aluation of the effect of Benson’s relaxation technique onin and quality of life of haemodialysis patients:randomized controlled trial

soume Rambod a,*, Farkhondeh Sharif b, Nasrin Pourali-Mohammadi c,lofar Pasyar d, Forough Rafii e

munity Based Psychiatric Care Research Center, Student Research Committee, Department of Medical Surgical, School of Nursing and

wifery, Shiraz University of Medical Science, Shiraz, Iran

mmunity Based Psychiatric Care Research Center, Department of Mental Health and Psychiatric Nursing, Faculty of Nursing and

wifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran

ool of Nursing and Midwifery, Shiraz University of Medical Science, Shiraz, Iran

partment of Medical Surgical, Faculty of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran

ter for Nursing Care Research, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran

T I C L E I N F O

le history:

ived 11 July 2013

ived in revised form 11 November 2013

pted 14 November 2013

ords:

modialysis

lity of life

xation therapy

A B S T R A C T

Background: Haemodialysis patients may suffer from pain and impairment of quality of life.

Some complementary interventions, such as relaxation therapy, might affect the pain and

quality of life. The present study aimed to identify the effectiveness of Benson’s relaxation

technique in relieving pain and improving the quality of life in haemodialysis patients.

Study design: The study was a randomized controlled trial.

Setting and participants: The data were collected in two haemodialysis units affiliated to

Shiraz University of Medical Sciences. A total of 86 haemodialysis patients were randomly

assigned to either the intervention (receiving Benson’s relaxation technique) or the control

group (routine care) from 2011 to 2012.

Intervention: The patients in the intervention groups listened to the audiotape of

relaxation technique twice a day each time for 20 min for eight weeks.

Measurements and outcomes: The pain numeric rating scale and Ferrans and Powers Quality

of Life Index-dialysis version questionnaire were completed at baseline and 8 weeks after the

intervention. The data were analyzed using independent t-test and ANCOVA.

Results: The results of ANCOVA showed a significant difference between the intervention

and the control group concerning the mean score of the intensity of pain (F = 6.03, p = 0.01).

Moreover, a significant difference was found between the intervention and the control

group regarding the total quality of life (F = 10.20, p = 0.002) and health-functioning

(F = 8.64, p = 0.004), socioeconomic (F = 12.45, p = 0.001), and family (F = 8.52, p = 0.005)

subscales of quality of life.

Conclusion: These findings indicated that Benson’s relaxation technique might relieve the

intensity of pain and improve the quality of life in haemodialysis patients. Thus, Benson’s

relaxation technique could be used as part of the care practice for relieving the pain

intensity and improvement of the quality of life in haemodialysis patients.

� 2013 Elsevier Ltd. All rights reserved.

Corresponding author at: School of Nursing and Midwifery, Shiraz University of Medical Sciences, Zand St., Namazee Sq., 7193613119 Shiraz, Iran.

+98 711 6474258; fax: +98 711 6474252.

E-mail addresses: [email protected] (M. Rambod), [email protected] (F. Sharif), [email protected] (N. Pourali-Mohammadi), [email protected]

Pasyar), [email protected] (F. Rafii).

Contents lists available at ScienceDirect

International Journal of Nursing Studies

journal homepage: www.elsevier.com/ijns

ease cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on paind quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/

0.1016/j.ijnurstu.2013.11.004

0-7489/$ – see front matter � 2013 Elsevier Ltd. All rights reserved.

://dx.doi.org/10.1016/j.ijnurstu.2013.11.004

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What is already known about the topic?

� End-stage renal disease has negative impacts on thequality of life and emotional, physical, cognitive, andsocial dimensions of one’s life.� Chronic pain is the most common and disabling

symptom in haemodialysis patients.� Benson’s relaxation technique may enhance the quality

of life and relieve the pain intensity of haemodialysispatients.

What this paper adds

� Haemodialysis patients who received Benson’s relaxa-tion technique showed better health-functioning, socio-economic, and family subscales of quality of life and totalquality of life.� Benson’s relaxation technique positively relieved the

intensity of pain in the haemodialysis patients.

1. Introduction

End stage renal disease (ESRD) is an irreversible andprogressive renal dysfunction (Baraz et al., 2010). Theprevalence of ESRD has significantly increased around theworld as well as in Iran (Roudbari et al., 2010).

One of the most common problems in ESRD andhaemodialysis (HD) patients is chronic pain (Masajtis-Zagajewska et al., 2011) and more than 50% of all ESRDpatients suffer from pain (Innis, 2006). In fact, most HDpatients suffer from moderate to severe pain and 54% of HDpatients show more than one location of pain (Masajtis-Zagajewska et al., 2011).

ESRD patients may suffer from pain in a number of waysthat are unique not only to the disease but also to thetreatment. Bone pain from renal osteodystrophy, periph-eral neuropathy, dialysis-related arthropathy, dialysisdisequilibrium syndrome, dialysis headache, and musclecramping during or after haemodialysis are the commoncauses of pain in HD patients (Shayamsunder et al., 2005).

The experience of pain is associated with manyimmediate and long-term negative outcomes (Alhani,2010). Besides, a significant correlation was foundbetween mortality and both frequency and intensity ofpain in the HD patients while they were not on dialysis(Harris et al., 2012). Furthermore, disabling symptoms(Nayak-Rao, 2011), depression, insomnia, severe irritability,anxiousness, and inability to cope with stress were morecommon among the HD patients with pain compared tothose without pain (Davison and Jhangri, 2005). Moreover,the patients with chronic pain may experience high levels ofdisability, distress, and societal burden (Breivik et al., 2006).Overall, chronic pain affects the quality of life (QOL) of theHD patients (Gomez Alonso, 2010).

Although treatments, such as HD, are able to prolonglife expectancy (Chow and Wong, 2010), the patients withESRD potentially experience an alternation in the level ofphysical activity, loss of job, and disturbance in the socialfunction (Unruh and Hess, 2007). These will have anegative impact on their life plans, employment status,

financial situation, self-esteem, and level of independence(Niu and Li, 2005), affecting the patients’ physical,psychological, and social well-being (Rambod and Rafii,2010). Besides, HD patients indicated lower physicalfunctioning QOL compared to the general population(Cleary and Drennan, 2005). They also experienced a lowerlevel of total QOL and health/functioning and familialsubscales of QOL compared to the transplanted patients(Rambod et al., 2011).

Recently, there has been an increasing interest in theuse of complementary interventions, such as relaxationtherapy, for the individuals with chronic illnesses (Tsai,2004) and pain management in the patients with ESRD(Innis, 2006). Relaxation techniques improve self-efficacy(Diezemann, 2011) and relieve psychological distress inthe patients with chronic illnesses (Yu et al., 2007).

Not surprisingly, non-pharmacologic treatments, suchas relaxation therapy, have resulted in improvement ofpain (Kwekkeboom et al., 2010). Relaxation techniqueslead to muscular stabilization and serve as distraction frompain (Diezemann, 2011). It has been indicated that 6-weekcombined progressive relaxation technique and guidedimagery intervention improved pain in the subjects withchronic and non-malignant pain (Chen and Francis, 2010).Yoga-based exercise program as a relaxation training alsodecreased the intensity of pain in HD patients (Yurtkuranet al., 2007). Although some studies have indicated thatrelaxation therapy is a potentially non-pharmacologicalintervention on pain relief and a variety of medicalconditions (Mohammadi Fakhar et al., 2013; Topcu andFindik, 2012), most of these studies have focused on otherrelaxation techniques, such as applied relaxation (Gus-tavsson and von Koch, 2006), relaxation and imagery (Chenand Francis, 2010), and a combination of relaxationtechniques and back massage (Buyukyılmaz and Astı,2013). In addition, these studies have examined otherdiseases, such as non-malignant pain (Chen and Francis,2010), long-lasting neck pain (Gustavsson and von Koch,2006), and total hip or knee arthroplasty (Buyukyılmaz andAstı, 2013).

In addition to the effect of relaxation therapy on pain,this technique has been shown to improve QOL in a varietyof conditions, including asthma (Nickel et al., 2006) andosteoarthritis in elderly women (Baird and Sands, 2006). Ithas also been recommended as an adjunctive therapy foranxiety by providing the patients with self-maintenancecoping skills to decrease the anxiety symptoms (Pan et al.,2012). Cheung et al. (2003) have indicated that the use ofmuscle relaxation significantly improved generic QOL inthe intervention group, especially in the domains ofphysical health, psychological health, social concerns,and environment. Moreover, it has been indicated thatolder women with osteoarthritis who received guidedimagery with relaxation experienced a better healthrelated QOL (HRQOL) compared to the control group(Baird and Sands, 2006). Furthermore, the patients withmultiple sclerosis using relaxation training reported moreenergy and vigor (Sutherland et al., 2005) as well as betterQOL (Ghafari et al., 2009) in comparison to the controlgroup. Also, they were less limited in their roles due tophysical and emotional problems (Sutherland et al., 2005).

Please cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on painand quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.11.004

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One of the plausible and attractive relaxation techniquesich is easy to learn is Benson’s relaxation technique. Sincest of the HD patients need vascular access, such asriovenous fistula and arteriovenous graft for HD

cedure, performing some exercises and relaxationhniques might be difficult for them. However, Benson’sxation technique can be better tolerated by these

ients. Nonetheless, a limited number of studies havecifically evaluated Benson’s relaxation technique in HDients (Elali et al., 2012). Benson (1975) presented thexation technique and denoted that it could bring aboutxation response by reducing the autonomic nervous

tem’s activity (Benson, 1975). This technique has beenorted to decrease anxiety level (Galvin et al., 2006),nitive and somatic anxiety (Kolt et al., 2002), moodurbance (Rabin et al., 2009), and body discomfort (Leon-

arro et al., 2007). It also improves attention, declarativemory performance (Galvin et al., 2006), and self-fidence (Kolt et al., 2002). It was indicated that Benson’sxation technique improved the patients’ well-being in aonic condition, such as rheumatoid arthritis (Bagheri-ami et al., 2006). This implies that this technique mightct the individuals’ life and QOL. However, no studiese been conducted on the effect of Benson’s relaxation

hnique on the intensity of pain and QOL of the ESRDients on HD. Thus, the present study aims to examine thectiveness of Benson’s relaxation technique in relieving

intensity of pain and improving the QOL in HD patients. following hypotheses were posed in this study: (1) after

ht weeks, the HD patients receiving Benson’s relaxationhnique show greater relief of pain compared to thoseeiving routine care. (2) The QOL and subscales of QOL in

HD patients receiving Benson’s relaxation technique inition to the routine care will be better compared to those

eiving the routine care alone after 8 weeks.

ethods

Design

The present study was a randomized, controlled trialmining the effects of Benson’s relaxation technique on

intensity of pain and QOL in HD patients.

Study settings

The study was performed at two HD units in Namazi Shahid Faghihi hospitals affiliated to Shiraz Univer-

of Medical Sciences, Shiraz (one of the big cities of).

Samples

The target population consisted of 260 HD patientsed in the two above-mentioned HD units. The patientsrring to these HD units of Shiraz University of Medicalnces were recruited into an intervention or a control

up. The inclusion criteria of the study were being 18rs old or above, having been on HD twice a week orre for at least the previous 3 months, and being alerted

and oriented. On the other hand, the patients havingunstable hypertension and angina, arrhythmia, congestiveheart failure, acute cerebrovascular accident, hepaticfailure, physical limitation for learning and performingthe relaxation technique, and prior training or current useof relaxation therapy were excluded from the study. Thepatients with emotional upheaval, such as death of arelative or a family member and divorce in their family,and those with any problems which had a negative impacton their mood during the previous month were excluded,as well. The reason for these exclusions was that thesecomplications might affect the concentration which isimportant in the relaxation technique and these patientsmight have difficulty in performing this procedure.

Based on the power of 80%, a = 0.05, and effectsize = 0.62, a sample size of 80 subjects (40 participantsin each group) was selected for the current study. Ofcourse, the sample size was raised to 86 patients to allowdropping-out.

During the study, two subjects in the interventiongroup were withdrawn due to kidney transplantation andlack of interest to continue. Also, three participants in thecontrol group were dropped from the study because ofkidney transplantation (n = 1), lack of interest to continue(n = 1), and no reason (n = 1). Therefore, a total of 81patients finished the study (41 patients in the interventiongroup and 40 in the control group) (Fig. 1).

2.4. Data collection

Data collection was performed from February 2011 toJanuary 2012. Following the eligibility assessment, thepatients were familiarized with the study and those whoagreed to participate received a consent form to sign.Afterwards, the study subjects were selected from the listof HD patients through simple random sampling using atable of random numbers. The participants were thenallocated into the intervention or the control group byblock randomization with a random sequence of 2 or 4block sizes.

The data were collected at the baseline from 15 minafter the beginning of HD until the first 2 h after it. It hasbeen reported that the patients are stable and any dialysis-related complications, such as change in blood pressure,stroke volume (Hawker et al., 2011), cramp, vomiting, andfeeling sick, are low during this period.

The socio-demographic data were collected throughface-to-face interview by the researcher’s assistant. A QOLquestionnaire and a pain Numeric Rating Scale (NRS) werealso filled out by the subjects while a researcher’s assistantwas at the patients’ bedside. On the other hand, in case thesubjects could not fill out the questionnaires since theirdominant hand was on dialysis or did not have sufficientvisibility and literacy, the researcher’s assistant asked eachitem and exactly inserted their answers into the ques-tionnaires. Data collection was also performed at the end ofthe 8th week of the intervention in the same way.

The data were collected by the researcher’s assistantwho was blind to the groups and the intervention duringtwo visits, one prior to and one after the eighth week of theintervention.

ease cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on paind quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/

0.1016/j.ijnurstu.2013.11.004

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2.5. Intervention

Relaxation training was performed in separate roomswhile the patient was in the bed in supine position. Theinstruction of Benson’s relaxation technique lasted for20 min and the subjects needed to: (1) sit in a comfortablecondition, (2) close their eyes, (3) completely make all theirmuscles less tense beginning from the soles of the feetforward up and relax all parts of the body, (4) breathethrough their nose, listen carefully to the sound of theirbreathing and when the breath was out, silently say theword ‘one’ to themselves, for example, breath in. . .out,‘one’; in. . .out, ‘one’. . ., and (5) continue for 20 min. Thepatients were instructed to check the time while openingtheir eyes; however, alarm did not have to be used(Bagheri-Nesami et al., 2006).

2.5.1. The intervention group

The intervention group underwent their relaxationtechnique two times a day (9 A.M and 17 P.M) each lastingfor 20 min during the study period as follows:

Before the dialysis session, an interventionist who wasblind to the aim and outcomes of this study verballydescribed the Benson’s relaxation technique for eacheligible subject. Then, the participants listened to thetechnique in an audiotape with earphones and performedit in the presence of the interventionist who provided afeedback by evaluating the subjects’ skill in performing thetechnique. After the training sessions, the patients wereasked to practice it for the next two days. Then, the patientsdid the technique again in the presence of the inter-ventionist in order to ensure that they had acquired

sufficient skills. It was repeated if necessary over one ortwo sessions until the interventionist confirmed that thepatients had adequate skills. A CD on the relaxation processwas also given to the patients in order to ensure theireffective learning. They were asked to listen to the CD onlytwice a day (9 A.M and 17 P.M) at home and simulta-neously perform the technique for 20 min for eight weeks.If performing the technique was not possible for a personat these times, it could be done twice a day at two specifictimes with a 7–8 h interval between each episode. Theparticipants were emphasized not to forget to perform thetechnique. However, if it happened, they were asked to doit as soon as possible.

Also, a self-reporting ‘‘performance record form’’ wasdaily filled out by the patients to ensure their compliancewith Benson’s relaxation technique. Every week, theinterventionist referred to the HD center and encouragedthe subjects to perform the technique and, at the sametime, their ‘‘performance record forms’’ were collected.Moreover, to ensure that the participants underwent theintervention appropriately, the subjects did the techniqueagain in the presence of the interventionist. Furthermore,the mobile phone number of one of the researchers (thefirst author) was given to the subjects and they were askedto contact her if they had any complications or questionsduring the technique.

2.5.2. The control group

The control group received the routine care without anyinterventions. The patients received the routine care asfollows: checking their vital signs, monitoring dialysis,reaction to the dialysis treatment and medication from the

179 eligible participants

Excluded (n = 93) � Did not have the inclusion criteria (n = 56) � Had exclusion criteria (n = 16) � Refused to participate (n = 14) � lackofinterest(n = 7)

86 Randomized

Allocated to experimental group (n = 43)Received Benson's relaxation technique

Allocated to control group (n = 43)Received routine care

Lost to follow-up (n = 3) Reason: Discontinue due to� kidney transplant (n = 1)� lack of interest (n = 1) � no reason (n = 1)

Lost to follow-up (n = 2) Reason: Discontinue due to� kidney transplant (n = 1) � lack of interest (n = 1)

Analyzed (n = 41) � Exclude from the analysis (n = 0)

Analyzed (n = 40) � Exclude from the analysis (n = 0)

Fig. 1. The flow diagrams of the participants through each stage of the study.

Please cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on painand quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.11.004

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inning to the end of dialysis, reviewing their medica- and lab data, and following them up through the stepsransplantation if necessary. Moreover, their medica-s and conditions were evaluated and changed based on

physician’s recommendation. To prevent bias, thejects were not offered any information about thexation therapy during the study period. However, aftert the 8th week of the study, a CD on the relaxationcess was given to the control group.

Measures

In this study, a socio-demographic and clinical char-eristics form, a pain NRS, and QOL Index were used toect the data. Benson’s relaxation technique wassidered as the independent variable, while the intensitypain and QOL were considered as the dependentiables. The participants in both groups were examinedthe pain intensity and QOL at baseline and at the end of

8-week intervention period.The socio-demographic and clinical characteristics

which was collected at baseline included the patients’, gender, marital status, educational level, and length ofe on HD (months).

1. Intensity of pain

The pain NRS which is the most widely appliedtrument for pain screening was used to measure thensity of pain. The pain NRS is a single 11-point numeric

le with a horizontal line which is 100 mm long. In thisle, number 0 at the far left indicates one pain extremeo pain’’) and number 10 at the far right represents theer pain extreme (‘‘pain as bad as you can imagine’’ andrst pain imaginable’’) (Jensen and McFarland, 1993;riguez, 2001). The scores range from 0 to 10 and higher

res indicate greater pain intensity. The participantsre asked to show the numeric value on the segmentedle that best explained their pain intensity. It takes lessn 1 min to complete this scale (Hawker et al., 2011).Test–retest reliability of the pain NRS has beenicated to be good in both literate and illiterate patientsh rheumatoid arthritis (r = 0.96 and 0.95, respectively)ore and after medical consultation (Ferraz et al., 1990).

construct validity, the pain NRS was observed to berelated with the Visual Analog Scale in the patients withumatic and other chronic pain conditions (pain >6nths) (correlations ranging from 0.86 to 0.95 (Downie et1978; Ferraz et al., 1990)). In our study also, the pain

S had high test–retest reliability (r = 0.94).

2. Quality of life

Quality of Life Index-dialysis version (QLI) (Ferrans anders, 1985, 1992) was used to measure the patients’

ceived level of QOL. It is a self-administered measure ofL containing two parts each including 35 items. Part 1asures the satisfaction with different aspects of life,ile part 2 measures the importance of the aspects to theject, using a 6-point Likert scale with endpoints of veryatisfied/very unimportant (1) and very satisfied/veryortant (6). The final score of this index ranges from 0 to

with higher scores indicating greater perceived QOL.

This questionnaire consists of four subscales; i.e., health-functioning, socioeconomic, psychological–spiritual, andfamily (Ferrans and Powers, 1985, 1992).

The validity and reliability of the QLI have been wellestablished in other studies (Ferrans and Powers, 1985,1992). The Persian version also had good internalconsistency (a = 90), test–retest reliability (r = 0.91), andcontent validity in Iranian culture (Rambod and Rafii,2010). In addition, internal consistency reliability coeffi-cients (Cronbach’s a) for each of the subscales of the QLIwere reported to range from 0.89 to 0.92 (Rambod andRafii, 2010). In this study, the alpha coefficient forreliability was 0.92 for the total items of QOL and rangedfrom 0.90 to 0.92 for the subscales.

2.7. Ethical considerations

The study was approved by the Ethics Committee ofShiraz University of Medical Sciences, Shiraz, Iran. Besides,informed consents were obtained from the HD patients afterthey were provided with verbal and written informationabout the study objectives and design. The subjects werealso ascertained about the confidentiality and anonymity oftheir information as well as their right to withdraw duringthe study. A numeric code and publication data were usedfor anonymity of each participant. Moreover, permission touse the QLI was received from the developers (Ferrans C).

2.8. Data analysis

The data were analyzed using the SPSS statisticalsoftware (Version 16). Independent t-test and Chi-squaretest were used to assess the differences between the studygroups regarding the socio-demographic characteristics.Independent t-test was also used to compare the twogroups at the baseline. In addition, since the length of timeon HD might affect QOL and intensity of pain (Bayoumiet al., 2013; Bohlke et al., 2008; Sathvik et al., 2008), tocompare the groups at the end of the 8-week interventionperiod, Analysis of Covariance (ANCOVA) model was usedin which the length of time on HD was considered as thecovariate. p-Values <0.05 were considered as statisticallysignificant. It should be noted that the data were analyzedby an individual who was blind to the study groups.

3. Results

3.1. Socio-demographic characteristics

Overall, 81 HD patients completed the study. The meanage of the subjects was 49.89 years (SD = 12.47) rangingfrom 20 to 82 years old. In addition, most of the HD patientswere male (61.6%) and married (79.14%). Besides, anelementary level of education was reported by 47.7% ofthe participants. The mean length of dialysis was 42.10months (SD = 38.48). The socio-demographic and clinicalcharacteristics of the subjects in each group are presented inTable 1. The results revealed no significant differencesbetween the patients of the control and the relaxationgroups regarding age, gender, marital status, level ofeducation, and the length of time on HD.

ease cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on paind quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/

0.1016/j.ijnurstu.2013.11.004

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The mean age of the study population was49.07 � 13.31 and 50.72 � 11.68 years in the interventionand the control group, respectively. Besides, the majority ofthe subjects in both intervention and control groups weremale (61.6% and 67.4%, respectively). In addition, 35 HDpatients (81.4%) in the relaxation group and 33 ones (67.7%)in the control group were married. Most of the subjects inboth study groups had elementary level of education (34.9%in the intervention and 60.5% in the control group) (Table 1).The intervention group was homogeneous with the controlgroup concerning all the socio-demographic and clinicalcharacteristics.

On the average, the intervention group performedBenson’s relaxation technique at home 11.34 times a week(SD = 2.55) and the mean of technique duration in each daywas 34.50 min (SD = 5.32). Moreover, the subjects most

frequently performed the technique at 9:35 A.M and 17:50P.M.

3.2. Intensity of pain

Prior to the study, the mean intensity of pain in theintervention and the control group was 5.65 � 3.41 and5.67 � 3.20, respectively. No statistically significant differ-ence was found between the two groups concerning the painintensity at the beginning of the study (t = �0.03, p = 0.97).However, the results of ANCOVA showed a significantdifference between the intervention and the control groupregarding the mean score of pain intensity (F = 6.03, p = 0.01).As shown in Fig. 2, after the relaxation technique, theintervention group’s mean score of pain intensity hadsignificantly decreased compared to the control group(3.90 � 2.70 vs. 5.57 � 2.78). Therefore, the first hypothesiswas confirmed.

3.3. Quality of life

The study findings revealed no significant differencebetween the two groups regarding the total QOL andhealth-functioning, socioeconomic, psychological–spiritu-al, and family subscales of QOL prior to the study (p > 0.05)(Table 2).

As can be seen in Fig. 3 and Table 2, the results ofANCOVA indicated a significant difference between theintervention and the control group concerning the meanscore of the total QOL (F = 10.20, p = 0.002). In addition, asignificant difference was observed between the inter-vention and the control group regarding the health-functioning (F = 8.64, p = 0.004), socioeconomic (F = 12.45,p = 0.001), and family (F = 8.52, p = 0.005) subscales of QOL(Table 2). On the other hand, the results of ANCOVAon the psychological–spiritual subscale of QOL indicatedno significant differences between the two groups(F = 3.27, p = 0.07) (Table 2). These results support thesecond hypothesis regarding QOL and 3 out of its 4subscales.

Table 1

Socio-demographic and clinical characteristics of the participants in the

intervention and control groups.

Socio-demographic and

clinical characteristics

Intervention

group, n (%)

Control group,

n (%)

p-Value

Sex

Female 14 (32.6) 19 (44.2) 0.18b,*

Male 29 (67.4) 24 (55.8)

Marital status

Single 4 (9.3) 4 (9.3)

Married 35 (81.4) 33 (76.7) 0.55b,*

Widowed 3 (7.0) 6 (14.0)

Divorced 1 (2.3) 0 (0.0)

Educational level

Primary school 15 (34.9) 26 (60.5)

Secondary school 11 (25.6) 7 (16.3) 0.12b,*

High school 7 (16.3) 5 (11.6)

College 10 (23.3) 5 (11.6)

Age (years) 49.07 (13.31)a 50.72 (11.68)a 0.54c,*

The length of time on

haemodialysis (month)

36.53 (36.05)a 47.67 (40.42)a 0.18c,*

a Mean (SD).b Chi-square statistics.c Independent t-test.

* No-significant.

3

3.5

4

4.5

5

5.5

6

end of the 8-weekbaseline

The

inte

nsity

of p

ain

interve ntion grou p

control group

Fig. 2. The intensity of pain in the intervention and control groups across the two study periods.

17

18

19

20

21

22

baseline end of the 8-week

Qua

lity

of li

fe

intervention group

control group

Fig. 3. The quality of life in the intervention and control groups across the two study periods.

Please cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on painand quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.11.004

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M. Rambod et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx 7

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Plan1

iscussion

The results of the study showed that Benson’s relaxa- technique relieved the intensity of pain in the HD

ients over time. Moreover, the relaxation group showedater improvement in the total QOL and health-ctioning, socioeconomic, and family subscales of QOLpared to the control group.

In our study, HD patients receiving Benson’s relaxationhnique reported greater relief of pain compared to thetrol group. In another study conducted on long-lastingk pain patients also, the relaxation group showed ater perceived control over pain at the 20th week of theow up compared to the control group (Gustavsson and

Koch, 2006). Positive effects of relaxation therapy haven indicated for chronic musculoskeletal back pain, asll (Linton, 1994). However, no published articles areilable reporting the effectiveness of Benson’s relaxationhnique in relieving the intensity of pain in HD patients.axation techniques and massage decreased anxiety byventing pain transmission to the spinal cord (Heye et2002) and relaxing the muscles (Gatlin and Schulme-r, 2007; Heye et al., 2002). Furthermore, relaxation

hniques stimulate endorphin secretion in the brain and to the feeling of relaxation in the muscles andpiness in the patients. It provides a level of analgesia for60 min (Buyukyılmaz and Astı, 2013). Since pain wasorted as one of the predictors of mental and physicallth related quality of life (Davison and Jhangri, 2010), it

seems that the decrease in pain may have contributedmprovement in QOL.In this study, Benson’s relaxation technique improved

total QOL of the HD patients over time. This findingported the results of a study indicating that progressive

muscle relaxation therapy was effective in improving theQOL in the dialysis patients (Yildirim and Fadiloglu, 2006).Our finding is also similar to that of other studies (Bairdand Sands, 2006; Cheung et al., 2001, 2003). It has beenshown that the patients with chronic conditions, such asbreast cancer and gastrointestinal cancer after stomasurgery, and older women with osteoarthritis, whoreceived relaxation training had better QOL in comparisonto the control groups (Baird and Sands, 2006; Cheung et al.,2001, 2003; Yoo et al., 2005). The direct effect of Benson’srelaxation technique on QOL was not clear. However, therelease of neurotransmitter opioids and nitric oxide hasbeen hypothesized and indicated in the studies describingthe health effects of the relaxation response (Dusek et al.,2006).

In our study, relaxation therapy enhanced the health-functioning subscale of QOL in the HD patients. Thisfinding was consistent with a study on the effect ofprogressive muscle relaxation therapy on improving the‘‘physical component score of QOL’’ in multiple sclerosispatients. Also, in a study on chronic diseases such as type 2diabetes, it was revealed that compared to the patients inthe tactile massage group, ‘‘role functioning and physical’’subscale of QOL was more desirable in those receivingrelaxation exercises at least once weekly for 10 weeks(Wandell et al., 2012). The positive effect of relaxation ondecreasing the physical problems in performing regulardaily activities and enhancing functional well-being(Chang et al., 2007) has also been shown in many studiesperformed on the cases other than ESRD.

This study showed that Benson’s relaxation techniqueenhanced the socioeconomic subscale of QOL over time.This finding was in line with the results indicating thatmuscle relaxation significantly improved the social

le 2

parison of the Benson’s relaxation technique (G1) and control (G2) groups regarding the total quality of life and their subscales.

ality of life Baseline,

mean (SD)

End of the 8-week,

mean (SD)

Mean difference,

mean (SD)

Paired t-test,

p-value

tal quality of life

G1 19.12 (3.86) 21.00 (4.14) �1.77 (2.36) 4.73; <0.0001*

G2 17.66 (4.58) 17.73 (4.55) �0.31 (2.40) 0.82; 0.41

Between groups; p 1.59a; 0.11 10.20b; 0.002*

ality of life subscales

alth-functioning

G1 17.37 (4.59) 19.44 (4.86) �1.90 (2.44) �4.91; <0.0001*

G2 15.89 (4.90) 16.07 (4.78) �0.25 (1.98) 0.81; 0.42

Between groups; p 1.44a; 0.15 8.64b; 0.004*

cioeconomic

G1 18.61 (4.23) 20.34 (4.36) �1.60 (2.31) �4.38; <0.0001*

G2 17.07 (4.07) 16.76 (4.39) �0.26 (3.17) �0.53; 0.59

Between groups; p 1.71a; 0.09 12.45; 0.001

ychological–spiritual

G1 19.98 (4.99) 22.12 (5.15) �2.15 (3.02) �4.50; <0.0001*

G2 18.49 (5.43) 19.12 (7.94) �1.18 (6.55) �1.13; 0.26

Between groups;p 1.32a; 0.19 3.27b; 0.07

mily

G1 23.49 (4.67) 24.8 (4.65) �1.12 (3.98) �1.78; 0.08

G2 21.93 (4.90) 21.88 (4.11) 0.70 (2.38) 1.48; 0.07

Between groups; p 1.49a; 0.13 8.52b; 0.005*

son’s relaxation technique group = G1 and control group = G2.

Independent t-test.

ANCOVA and the length of time on haemodialysis as a covariate.

p-Values indicate the level of significance.

ease cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on paind quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/

0.1016/j.ijnurstu.2013.11.004

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concerns and environment domains of QOL in thecolorectal cancer patients (Cheung et al., 2003). Moreover,in a study on chronic heart failure, it was indicated thatrelaxation therapy could prevent the deterioration of thesocial HRQOL (Yu et al., 2010). The protective effect ofrelaxation on social HRQOL may result from the physio-logical and psychological effects of relaxation. Moreover,improving the physiological symptoms, such as fatigue,sleep disturbance, and grip strength and psychologicalconditions, including anxiety and depression (Bagheri-Nesami et al., 2006), by Benson’s relaxation techniquemight result in the patient’s greater social participationand role performance. Another protective effect ofrelaxation may also be related to coping with the effectsof the disease in a way that permits them to functionadequately in their work, society, and general activities(Sutherland et al., 2005). Consequently, social life couldhave positive effects on the economic status.

In this study, although the mean score of thepsychological–spiritual domain of QOL improved in theintervention group over time, no significant difference wasdemonstrated between the intervention and controlgroups at the end of the 8-week intervention period. Thismight be due to the high mean score of ‘‘Faith in God’’ itemat the beginning of the study. One study also showed faithin God, spirituality, and religiosity to be very importantamong the HD patients as well as in the Iranian culture(Rambod and Rafii, 2010).

The findings of this study indicated that Benson’srelaxation technique improved the family domain of QOLover time. In the review of literature, there were fewpublished articles reporting this domain. Overall, therelaxation technique improved the positive attitudestoward the illness (Oldenburg et al., 1985), anxiety,depression (Bagheri-Nesami et al., 2006), satisfaction ofone’s spouse and children, and the family’s health andhappiness.

4.1. Clinical implications

The implication of this study for practice is that Benson’srelaxation technique, a cost effective, safe, and low risktechnique which can be easily taught and used (Mahdavi etal., 2013), could help the patients to reduce the painintensity and improve QOL. Consequently, it has severalbenefits if practiced regularly daily (9 A.M. and 17 P.M.) foran 8-week period. Since improvement of QOL is the mostcommon problem experienced by the patients on HD andBenson’s relaxation technique reduced this concern, it issuggested that the advantages of this approach (e.g. it is notcomplex, takes little time to perform, does not need anyspecial device or place, does not need any change in life style,is easily learned, and is not forgotten after it is performed forseveral times) be clarified to healthcare providers and thepatients as well as their families.

4.2. Limitations

This study had some limitations. The first limitation wasthe short follow-up period after the intervention. Thus,future longitudinal studies are suggested to be conducted on

the long-term effects of Benson’s relaxation technique onESRD. The second limitation of this study was that thesubjects were selected from two local hospitals in one of thebig cities of Iran. Consequently, the results cannot begeneralized to the individuals living in other parts of theworld and having characteristics different from those in thecurrent study. The third limitation was the small sample sizewhich limited the power of the study to detect thestatistically significant differences. By increase in samplesize, the possibility of a markedly deviant samplediminishes. In fact, large samples provide the ground forcounterbalancing the atypical values (Polit and Beck, 2012).

In this study, the length of time on HD was consideredas covariate. Since QOL has been reported to be associatedwith other variables, such as psychosocial factors (e.g. traitanxiety, depressive symptoms, and lack of social support)(Vazquez et al., 2005), life satisfaction, and perception ofburden of illness (Patel et al., 2002), these variables aresuggested to be controlled in future studies.

In this study, one of the concerns which might havediminished the relaxation was that the participants in theintervention group needed to check the time while theywere doing the technique.

Some of the HD patients who had physical limitationwere excluded from the study, while these patients mighthave benefited from the intervention. Therefore, futurestudies are recommended to involve these patients, aswell. Further studies are also required in order to confirmand refine the estimates of this intervention on the QOL.Moreover, future studies are recommended to be con-ducted on this technique and its effects on ESRD patientson other renal replacement therapies, such as peritonealdialysis and renal transplantation, as well as those withother chronic diseases. In this study, only the intensity ofpain was measured. Thus, future studies are recommendedto examine the effect of Benson’s relaxation technique ontype, location, and duration of pain as well as themedications used to treat the pain in the HD patients.

This study did not measure the anxiety and stress levelsin order to determine the actual relaxation achieved.Therefore, further studies are required in this regard.

5. Conclusion

The results of this study showed that Benson’srelaxation technique significantly relieved the intensityof pain and improved the QOL and health-functioning,socioeconomic, and family subscales of QOL in the HDpatients. The study provided an evidence-based interven-tion for healthcare providers attempting to relieve the painand promote the QOL in the HD patients.

Conflicts of interest

There were no conflicts of interest.

Ethical approval

The study was approved by the Ethics Committeeof Shiraz University of Medical Sciences, Shiraz, Iran(88-4666).

Please cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on painand quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.11.004

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M. Rambod et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx 9

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Plan1

ding

This study was a research project financially supportedShiraz University of Medical Sciences, Shiraz, Iran-4666).

nowledgments

The clinical trial was registered in IRCT and allocated aque code as IRCT2013061613690N1. Special thanks goShiraz University of Medical Sciences as well as thelthcare providers from haemodialysis units for theiristance. The authors also wish to acknowledge all the 86dy participants for contributing their time and effort to

study. The authors also would like to thank Researchrovement Center of Shiraz University of Medicalnces and Ms. A. Keivanshekouh for improving the

of English in the manuscript. Dr. Mehrdad Vossoughi Sareh Roosta in the Center for Development of Clinicalearch of Namazi Hospital are also appreciated for theiristical assistance.

erences

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Please cite this article in press as: Rambod, M., et al., Evaluation of the effect of Benson’s relaxation technique on painand quality of life of haemodialysis patients: A randomized controlled trial. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.11.004