RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCESKARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECT FORDISSERTATION

1 NAME AND ADDRESS OF THE CANDIDATE

Ms. KALAICHELVI. AACHARYA COLLEGE OF NURSING,CHOLANAGAR, R. T. NAGAR POST, BANGALORE

2 NAME OF THE INSTITUTION ACHARYA COLLEGE OF NURSING, CHOLANAGAR,R.T.NAGAR POST,BANGALORE 32.

3 COURSE OF THE STUDY AND SUBJECT

M.Sc NURSING 1st YEARMEDICAL SURGICAL NURSING

4 DATE OF ADMISSION TO COURSE

26/10/2009

5 STATEMENT OF THE PROBLEMA STUDY TO EVALUATE THE EFFECTIVENESS OF STRUCTURED TEACHING PROGRAMME ON KNOWLEDGE REGARDING CARE OF PATIENT WITH AN IMPLANTED CRDIAC DEVICE AMONG STAFF NURSES WORKING IN SELECTED HOSPITALS, BANGALORE.

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6. A BRIEF RESUME OF THE INTENDED WORK

“The intuitive mind is a sacred gift and the rational mind is a faithful servant”

-Albert Einstein.

INTRODUCTION

Globally, cardiovascular disease is the number one cause of death and in 2005 cardiovascular disease was responsible for approximately thirty percent of deaths worldwide. Cardiovascular disease is a broad term that encompasses such varied illnesses as coronary artery disease, peripheral arterial disease, cerebrovascular disease, rhythmic disorders, rheumatic heart disease, congenital heart disease, and congestive heart failure1.

Cardiac disease in India has quadrupled in the last 40 years and WHO estimated that by 2020 close to 60 percent of cardiac patients worldwide will be Indian. The established risk factors of cardiovascular disease include lack of exercise, poor diet, and smoking. The cardiovascular crisis is glaringly evident in developing countries, and especially in India. While India is still trying to shake off diseases rooted in poverty, both their urban and rural areas are experiencing a mounting epidemic of cardiovascular disease2.

Cardiologists blame drop in age of heart disease affecting Indians to faulty food intake (including excessive consumption of milk products and junk food), sedentary lifestyle and stress. Genetic disposition of Indians has also been identified as a prime cause for early onset of cardiac problems. “Heart disease manifested almost a decade earlier in Indians than in other ethnic groups, thus contributing to the excessive long-term morbidity and higher cost of treatment3.

More than 80 million people worldwide have some form of cardiovascular diseases, as estimated by the American Heart Association. Sudden cardiac death accounts for 300,000 deaths in the US each year. Atrial fibrillation affects 10 million people worldwide4.

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Prevalence of Congestive Heart Failure in India was 18.8 million Indians (1.76% of population), the Incidence rate was 1.57 million per year (0.15%). More than 1 million patients with heart failure are now eligible to receive device therapy. Prevalence of Congestive Heart Failure in the US was 4.8 million Americans (1.76% of population). In which 2% of age 40-59, 5% of age 60-69, 10% of age over 70. The Incidence rate was 432 thousand per year (0.15%) 5.

As health professionals, our practice is constantly becoming more complex and diverse. We are also engulfed in technology in the pursuit of improving quality of life for our patients. Why? The answer is sudden cardiac arrests (SCA), also referred as sudden cardiac death. About 325,000 SCA occur annually in the United States, of which 163,221 SCA take place out-of-hospitals. An unusual rapid heart rate of unknown cause comes and goes, even when at rest. The result is a malfunction in the heart’s electrical system that leads to ventricular tachycardia and ventricular fibrillation, the immediate cause of SCA6.

It was estimated that 75% of SCA had a previous heart attack. Roughly 330,000 CHD deaths take place out-of-hospital annually. CHD is also the leading cause of death in women. Bradyarrhythmias account for approximately 20-30% of all SCA6.

Cardiovascular disease, now the leading cause of death, strikes Indians early and kills many in their productive mid-life years. Deaths due to CVD, in the age group of 35 to 64 years, resulted in 9.2 million potentially productive years of life being lost in 2000 and are expected to rise to a loss of 17.9 million years in 20307.

As per reports, the overall sales in the global market for cardiovascular devices in 2008 amounted to US Dollar 76.7 billion, while the projected sales for 2010 are an estimated US Dollar 86.4 billion. At a compound annual growth rate of 2.8 percent, year 2015 will witness sales of cardiovascular devices to be valued at a phenomenal US Dollar 97.3 billion. Cardiac rhythm management and cardiovascular monitoring and diagnostic devices represent high growth opportunities for the overall cardiovascular devices market. The treatment and diagnosis of cardiovascular diseases have and will provide the requisite impetus for undisputed growth of the overall cardiovascular devices segment4.

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Treatment of the cardiac diseases depends on the severity of the symptoms which the patient have. Drug therapy such as beta blockers, diuretics, digoxin will be prescribed for commencing stage of heart disease. Devices are often used in patients with heart failure to prolong life. Sudden cardiac death is caused by an abrupt arrhythmia that results in lack of blood flow to the brain and can result in death. This condition can be treated with an implantable cardiac defibrillator that will deliver a shock to the heart when it recognizes such a rhythm and shock the heart back into normal rhythm. Another device that has been recently used to treat heart failure is called a biventricular pacemaker. This is a device that is used in patients that have a bundle branch block. These devices have been shown to improve quality of life, exercise tolerance and mortality. Cardiac transplantation is done in patients with severe end stage heart failure8.

Patients with implanted cardiac devices constitute a growing segment of the contemporary healthcare practice. According to the American Heart Association, more than 170,000 pacemakers and 30,000 implantable cardioverter-defibrillators (ICDs) are implanted in the United States each year9.

Since there were released the results of the Multicenter Automatic Defibrillator Implementation Trials (MADIT I and II), which found ICD treatment is superior to drug therapy for the treatment of ventricular arrhythmias, the number of implantations of ICDs has quadrupled 10,11.

In fact, pacemakers with biventricular pacing capability, some of them combined with ICD function, are now being implanted for New York Heart Association Class III and IV heart failure patients aiming to improve their quality of life and increase their life expectancy 12.

A recent study which pooled data from three trials of 1,080 patients found that cardiac resynchronization (biventricular pacemaker-based therapy) decreased the risk of death from progressive heart failure (often sudden death from lethal arrhythmias) or cardiac transplantation compared to the control group by 59%. 13

Similarly, recent data from the registry of the European Heart Rhythm Association have shown that, despite the fact that ICDs are underused in Europe; device implantation rate exhibits an increased trend in most European countries over the last few years 14.

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A recent report in the premier medical journal, 60 percent of the world’s heart patients will be in India. The majority of these patients will suffer from cardiac arrhythmias, heart failure and coronary artery diseases. Implantable cardiac devices such as pacemakers, de-fibrillators, cardiac therapy devices and coronary stents play a major role in the treatment of these life-threatening conditions 15.

The process of implanting these cardiac devices is complex and requires highly specialized and technically skilled practitioners., Medtronic has a mobile unit launched in 2004, which travels all over the United States, training health professionals. It has, so far, trained over 8,500 physicians, nurses and other health professionals via its mobile training unit.15

Division of Cardiology, Italy shows the statistical data of implantable cardiac devices. In which Implantable cardioverter-defibrillator implantation had done for 4692 patients in 2005 (44.2%), 5938 patients in 2006 (52.2%), 7324 patients in 2007 (55.7%). Single-chamber ICDs were implanted in 30.9, 31.0, and 28.5% of patients, dual chamber ICDs in 31.9, 31.5, and 31.7%, and biventricular ICDs in 37.2, 37.5, and 39.8%, respectively. The ICD implantation rate in Italy increased significantly in the period 2005-07. The registry showed a significant increase in prophylactic and biventricular ICD use, reflecting a favorable adherence to trials and guidelines in the clinical practice 16.

Taking care of such a rapidly growing patient population constitutes a challenge for all health care providers working in a cardiology ward, operating room or primary care practice. Nurses among them have a unique role by being the most appropriate persons to provide in-hospital and long term health care, education and psychological support to these patients 17.

6.1. NEED FOR THE STUDY

Cardiac diseases such as Ischemic heart disease, mainly heart attacks and coronary artery disease are the leading cause of mortality in the world, accounting for 7.1 million deaths in 2001. More than 80 per cent of these were in developing countries18.

India will carry 60 per cent of the world’s heart disease burden, nearly four times more than its share of the global population, according to a study. Adding to the burden is

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a higher incidence of the types of heart disease resulting in serious illness and mortality, and the fact that these conditions strike at an earlier age, says the study. Death rates are especially high among the country’s poorest residents, unable to get to hospital quickly in an emergency, or to afford routine treatments and surgery18.

Epidemiologists in India and international agencies have been sounding an alarm on the rapidly rising burdens of CVD for the past 15 years. They reported prevalence of coronary heart disease in adult surveys has risen 4-fold over the last 40 years (to a present level of around 10%), and even in rural areas the prevalence has doubled over the past 30 years (to a present level of around 4%). Cardiovascular disease is now the leading cause of death, accounting for 29% of all deaths in 2005. A verbal autopsy study conducted in 45 villages of a southern state, the findings revealed that 32% of all deaths were due to CVD, outranking infectious diseases, which were responsible for 13%7.

Heart rhythm disorder comprises of fast heart rhythm known as tachycardia and slow heart rhythm known as bradycardia. In USA, more than 300,000 sudden cardiac deaths occur every year. In India with 1 billion populations, the incidence of cardiac disease especially coronary artery disease is very high. The sudden cardiac death in India is estimated to be much higher due to increased prevalence of coronary artery disease19.

Therefore there is an urgent need for specialty clinics to identify and treat these patients. Asian heart institute is fully equipped to treat the cardiac rhythm disorder, which is the predominant cause for sudden cardiac deaths. 19

The WHO estimates that, over the next 10 years, India will lose 237 billion US Dollars due to heart disease, stroke, and diabetes. The union budget presented by the Finance Minister of India, allocated 4 million U.S. dollars to a National Program for the Prevention and Control of Diabetes, Cardiovascular Diseases, and Stroke. If these looming threats of escalating epidemics of diabetes and CVD are neglected, the adverse effects on development are likely to be unaffordable for a country that is now on the fast track for economic development and aspires to be a major economic power in the 21st century7.

Implanted cardiovascular devices represents a growing market within the medical technology and equipment segment because of continual increase in the number if people suffering from cardiovascular diseases and conditions. In addition, leading vendors worldwide are focusing more on research and development activities in this domain

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leading to development of exciting technologically advanced devices and techniques for treatment of cardiovascular diseases and conditions. This will not only guarantee strong revenue growth for the vendors developing these technologies, but also provide enhanced value to the patients as well as the cardiologists 4. 

The use of medical devices, such as cardiac pacemakers, prosthetic heart valves and vascular prostheses, has become a routine treatment procedure in cardiovascular medicine. Unfortunately, bacterial infections of these devices are a serious and sometimes life-threatening for the patient, necessitating explanation. Despite implementing different prophylactic strategies to avoid contamination of the device, infections do occur 20.

A study was conducted on hazards of Patients with active implantable cardiac devices and systems, the result showed due to mismanagement of the device about 41% are at risk of injury, and it could cause tissue damage resulting in severe injury or death. They concluded that health professionals especially nurse should be educated under in-service education program about management of patient with implanted cardiac devices 21.

A recent study report of serious injury resulting from implanted cardiac defibrillators, Canada issued a Notice to Hospitals entitled "Important safety information regarding patients with implanted devices and implanted systems with leads". It warned about the risks of tissue overheating, serious injury and death in this group of patients. It suggested that all health professionals should be educated about care of patient with implanted cardiac devices 21.

A recent study report of rising rate of cardiac device infection, US reveals the infection rates vary between 2% and 8%. Treatment typically involves the removal of all implanted hardware, in addition to long-term antibiotic therapy. They concluded that beyond the highly specialized role of a pacemaker nurse, any nurse working in a primary health care setting should be familiar with at least some general aspects of the implanted cardiac device patients follow up care and provide counseling to this patient population 17.

Staff nurses’ play a major role in hospital and long-term care will ensure an uneventful procedure and a safe discharge as well as early detection of device malfunction and late complications. Education of the patient will prevent any self or environmental interactions which can adversely affect proper device function and will increase his or her

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adherence to the follow-up treatment. Finally, by providing psychosocial and emotional support the nursing staff can address the immediate concerns of the patient and help him or her cope successfully with the new life situation. Continuing education is extremely important for nurses counseling patients with implanted devices in order to play their role successfully as the continuous link to the multidisciplinary team of professionals that guide the oftentimes forgotten humanistic care of these patients 17.

All these above mentioned factors have urged the researcher to assess and educate the staff nurses knowledge about care of patient with implanted cardiac devices for patient wellbeing by using intervention based measures.

6.2 REVIEW OF LITERATURE

This chapter deals with the review of literature. Related literatures were reviewed to gain insight into the problem selected. The literature found useful has been presented in this chapter.

The results of studies conducted in various aspects on implanted cardiac device are presented below:

6.2.1. Review of literature related to prevalence of cardiac diseases

6.2.2. Review of literature related to implanted cardiac device and its management

6.2.3 Review of literature related to knowledge of staff nurses on care of patient with an implanted cardiac device

6.2.4. Review of literature related to effectiveness of structured teaching programme regarding care of patient with implanted cardiac device among the staff nurses.

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6.2.1. Review of literature related to prevalence of cardiac diseases

A random survey was performed on prevalence of cardiac diseases in India. The

result showed that by 2010 there will be close to 100 million heart patients in India. Now

it is 30 million. They concluded that Cardiac diseases have nearly doubled in India, an

alarming fact, considering that it has almost halved in Europe and the USA 22.

A study was conducted on prevalence rates of cardio vascular disease in India.

The result showed that the Challenge of Cardiovascular Disease 13.5% in India about 50

percent of related deaths occur among people younger than 70. They concluded that, the

prevalence rates among younger adults (age group of 40 years and above) are also likely

to increase 23.

A study was conducted on prevalence of heart attack in India. A survey performed

in hospitals. The result showed that there are about 12% of people pertaining for heart

attack, about 2000 implantable cardiac device procedures performed every year. They

concluded that every year there are so many people complaining with cardiac diseases in

which 80% of them are poor people 24.

6.2.2. Review of literature related to implanted cardiac device and its management

A study was conducted on a follow-up of patients with implantable cardioverter

defibrillators in United States. Population of this study involves 381 patients who

received an implantable cardioverter defibrillator were followed for up to 9 years. The

result showed that the device was effective in preventing sudden cardiac death with

survival rates of 97% at 3 years and 94% at 5 years. Complication rates were low. They

concluded that implantable cardioverter defibrillators are effective for management of

serious ventricular dysrhythmias and also minimizing the mortality rates 25.

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A study was conducted on Quality of life in patients with an implantable

cardioverter-defibrillator in Delhi. The sample of the study was 80 patients by

convenience sampling method. Questionnaire was given to assess the quality of life to all

selected patients. The result showed that there is significant increase in quality of life of

patient with implantable defibrillators up to 5 years. They concluded that implantable

cardiac devices plays major role of increasing patient well being 26.

A comparative study was conducted on malfunctions of patient with implantable

cardiac devices and patient with drug therapy for the treatment of congestive heart

failure, rhythmic disorders in New York. Totally 738 patients were selected by simple

random sampling method to assess the malfunctions over the period of 5 years by

assessment tool and questionnaire. The result showed that Compared with medications

(21%) for similar medical problems, these devices (38%) had efficacy and malfunction

(complication) rates that are much better. They concluded that implanted cardiac devices

are very effective in management of cardiac diseases 27.

6.2.3 Review of literature related to knowledge of staff nurses on care of patient with an implanted cardiac device

A survey was designed using a purposive sample of 152 nurses from cardiology

areas in four large teaching hospitals and a 28-point postal questionnaire to explore

knowledge of the device and its impact. The result showed that Knowledge of the device

and its effects appeared poorly understood by all nurses, irrespective of additional

qualifications, length of time since qualifying or area of work. They concluded that most

subjects were not confident in their abilities to prepare patients for implant or life at home

after implant and Lack of understanding may impair preparation of patients for

implantation of or for living with an implantable cardioverter defibrillator28.

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A study was conducted to assess the nurses’ knowledge and practice regarding

post operative care, following cardiac device implantation, London. They found that

certain aspects of established practice are based on tradition rather than evidence. Nurses

are lacking in some aspects of knowledge in giving care. They concluded that nurses

should play a key role in identifying and addressing research questions that lead to

improved patient outcome29.

An explorative study was conducted on knowledge regarding importance of

emergency identification scheme on patient with implanted cardiac devices among 190

senior nurses. Standardized questionnaires were sent to senior representatives. The result

showed that majority 59% of the personnel not aware of the identification of symptoms

during emergency. They concluded that it is vital that all staff routinely search patients

for any abnormality with sufficient knowledge30.

A study was conducted on Nurses knowledge and practice on Management and

Outcome of patient with Permanent Pacemaker and Implantable Cardioverter-

Defibrillator Infections, California. Data collection was done through questionnaire and

observation check list. They resul showed that lack of knowledge and timely

management by the nurse practitioner on patient with any implantable cardiac device lead

to certain complications 31.

A cross sectional survey was conducted on knowledge regarding management of

implantable cardiovertor defibrillators among nurse administrators in hospice, United

Sates. They selected 414 hospice, they sent questionnaire to all nurse administrators. The

result revealed that they are poor in knowledge of management of patient with ICD when

patient in end life care32.

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6.2.3. Review of literature related to effectiveness of structured teaching programme

regarding care of patient with implanted cardiac device among the staff nurses.

A study was conducted on effectiveness of nursing education regarding

knowledge and practice of post operative care of patient with a permanent cardiac anti

arrhythmic devices among nursing professionals, Chicago. This study was conducted

over three year period. They observed a high CDI (Cardiac Device infections) rate

associated with substantial morbidity in the beginning in their practice due to lack of

knowledge. The result showed that there is significant difference in their knowledge and

practice level after implementing the nursing education program (P<0005). They

concluded that the nursing education measures had an impact on CDI in prevention they

also suggests that implementation of a comprehensive teaching program is feasible and

efficacious among nurses33.

A study was conducted on effectiveness of teaching programme on knowledge

regarding care of patient with cardiac assist devices among nurses, Columbia. They teach

device care during the annual skills fair. The result showed that nurses knowledge level

was high as compare to pre test. They concluded that patients are the beneficiaries of

professional, competent nursing care by providing teaching programme34.

A study was conducted on effectiveness of nursing education programme on

knowledge regarding care of patient with implanted cardiac pacemaker among nurses,

USA. The goal of the study is to provide knowledge and detailed information to the

nurses regarding implanted cardiac pace maker care. The result of the study revealed that

the knowledge regarding guidelines for the assessment of pacemaker functions, detection

of malfunction and reprogramming techniques that helps the nurses to become

independent in their management of the follow-up care of these patients35.

A study was conducted on effectiveness of structured teaching programme on

knowledge regarding quality care functioning of the implantable cardiac devices among

nurses, USA. The result showed that in pre test the nurses lacked in operation of devices,

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and patient physiological and psychological responses to the technology. After

implementing the Structured teaching programme the nurses made important difference

in management of patient with implantable cardiac devices35.

A study was conducted on knowledge regarding nursing care for patients with

implantable defibrillators among nurses, Delhi. A teaching protocol given to 400 nurses

by convenience sampling method, study period was one year. The result showed there is

doubtless change among nurses in their knowledge and assisting patients to assume the

role of being their own most important healthcare manager.36

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6.3. STATEMENT OF THE PROBLEM

A STUDY TO EVALUATE THE EFFECTIVENESS OF STRUCTURED

TEACHING PROGRAMME ON KNOWLEDGE REGARDING CARE OF PATIENT

WITH AN IMPLANTED CARDIAC DEVICE AMONG STAFF NURSES WORKING

IN SELECTED HOSPITALS, BANGALORE.

6.4. OBJECTIVES OF THE STUDY

1. To assess the pretest knowledge on care of patient with an implanted cardiac device among experimental and control group.

2. To compare the pretest and posttest knowledge on care of patient with an implanted

cardiac device between experimental and control group.

3. To evaluate the effectiveness of structured teaching programme by comparing pretest and posttest knowledge on care of patient with an implanted cardiac device between experimental and control group.

4. To find the association between posttest knowledge on care of patient with an implanted cardiac device of experimental and control group and their selected demographic variables.

6.5 OPERATIONAL DEFINITIONS

1. Evaluate

It refers to the statistical analysis of pretest and posttest knowledge as elicited by structured knowledge questionnaire on care of patient with an implanted cardiac device among staff nurses.

2. Effectiveness

It refers to significant gain in the knowledge as determined by the statistical difference between posttest scores of experimental and control group on care of patient with an implanted cardiac device among nurses.

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3. Structured teaching programme It is a systematically organized planned teaching material to educate regarding

care of patient with an implanted cardiac device. It includes definition of implanted cardiac devices, its types, to whom it to be implanted, (preparation of the patient) pre operative preparation, immediate post operative care and long term health care. Immediate post operative care includes progressive monitoring, wound care, activity, etc. and long term health care includes follow up activity, patient education, and psychological support.

5. Knowledge It is the information and skills acquired through experience and education. In this

study it refers to correct reaction of nurses to the questionnaires given.

6. Care

In this study care refers to nurses’ unique role by being the most appropriate persons to provide in-hospital and long term health care, education and psychological support to these patients.

7. Patient

A person who is ill or undergoing treatment for disease. In this study patient refers to those who are treated with an implanted cardiac device for any cardiac disease.

8. Implanted cardiac device

Implanted Cardiac Devices operate within the human body in both monitoring and therapy delivery capacities. These devices are categorized as Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy (CRT) devices. Each of these electronic devices delivers a controlled electric shock to the heart, to return the heart back to a normal rhythm

9. Staff nurses

In this study staff nurses refer to professionals who are formally trained and registered and are working in all types of health set ups.

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6.6 HYPOTHESIS

H1: There will be a significant difference between mean pre test and post test knowledge scores among experimental and control group.

H2: There will be a significant difference in mean post-test knowledge score of staff nurses on care of patient with an implanted cardiac device between experimental and control group.

H3: There will be a significant association between mean post-test knowledge scores of experimental and control group and selected demographic variables of staff nurses.

6.7 RESEARCH VARIABLES

-Dependent Variable

Knowledge on care of patient with an implanted cardiac device among nurses those who are working in wards.

-Independent Variable

Structured teaching programme on care of patient with an implanted cardiac device

-Demographic Variables

Age, sex, marital status, Professional Qualification, present Designation, Year of Experience, previous source of information, Types of ward and Income.

6.8 ASSUMPTIONS

-All staff nurses need to be educated regarding care of patient with an implanted cardiac device.

- Structured teaching programme provides information and enables the staff nurses to gain more knowledge on care of patient with an implanted cardiac device

-Structured teaching programme could be an effective teaching tool.

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-By giving structured teaching programme the nurses by gaining adequate knowledge can improve the quality of life of patient with an implanted cardiac device.

-Structured teaching programme will aid the nurses in careful monitoring and preventing expected complications in patient with an implanted cardiac device.

6.9 DELIMITATION

-The period of study will be limited to one month.

-The study is limited to nurses who are working in selected hospitals of Bangalore.

6.10 PROJECTED OUTCOME

Structured teaching programme provided through the study will be beneficial to the staff nurses by improving their knowledge regarding care of patient with an implanted cardiac device and also the findings of the study will insist the importance of teaching programme given to the staff nurses working in selected hospitals to improve the patient outcome.

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7. MATERIAL AND METHOD

7.1 SOURCE OF DATA

7.1.1 RESEARCH DESIGN

The research design which is most suited for this study is True experimental design (pre test and post test design).

KEY WORDS

G1- Staff nurses in experimental group

G2- Staff nurses in control group

X- Structured teaching programme on care of patient with an implanted cardiac device for Experimental group is conducted on same day after conducting pretest.

O1: pretest for experimental and control group on 1st day.

O2: post test for experimental and control group on 7th day

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Group of staff nurses PRE TEST

Day-1

INTERVENTION

Day-1

POST TEST

Day-7

Experimental group G1

Control group G2

O1

O1

X O2

O2

7.1.2 RESEARCH SETTING

The study will be conducted in selected hospitals, Bangalore.

7.1.3 POPULATION

Study of population consists of all the staff nurses of selected hospitals, Bangalore.

7.1.4 SAMPLE

The sample consists of staff nurses in selected hospitals who will fulfill the inclusive criteria.

7.1.5 SAMPLE SIZE

Sample size is 80 in which experimental group is 40 and control group is 40.

7.1.6 SAMPLING TECHNIQUE

In this study simple random sampling (lottery method) technique was used to select the sample based on inclusive and exclusive criteria and the samples are allotted to the experimental and control group by means of lottery method.

7.1.7 SAMPLING CRITERIA

Inclusion criteria

Staff nurses:

-who are willing to participate in the study.

-who have completed diploma in nursing or B.Sc nursing degree.

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-working in medical surgical wards of selected hospitals.

Exclusion criteria

Staff nurses:

-who are trained in cardiology nursing

-who have been experienced less than 6 months

7.2 METHODS OF DATA COLLECTION

Instruments used for study

The data collection will be done with the help of structured questionnaire.

SECTION A- It contains demographic data like Age, Sex, Marital status, Professional Qualification; present Designation, Year of Experience, previous source of information, types of ward and Income..SECTION B- It consists of questionnaire regarding care of patient with an implanted cardiac device.

7.2.1 DATA COLLECTION METHOD

Content validity will be ascertained in consultation with the guides and experts in the field of medicine and nursing. Reliability of the tool will be established by test and re-test method. A prior permission will be obtained from the concerned authority; an informal consent will be obtained from the subjects. The process of the study will be explained to the subjects. A structured questionnaire will be administered to the subjects to assess the demographic status and knowledge regarding care of patient with an implanted cardiac device. A structured teaching programme on care of patient with an implanted cardiac device will be conducted to the staff nurses and post test questionnaire is administered after 7 days.

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7.2.2 PLAN FOR DATA ANALYSIS

The data obtained were analyzed in term of objective of the study using descriptive and inferential statistics. The plan of data analysis was as follows.

Organization of data in master sheet / computer. Background information in terms of frequency and percentage. The knowledge on care of patient with an implanted cardiac device will be analyzed in terms of frequency, percentage, mean and standard deviation Paired ‘t’ test to test the significant difference in the knowledge between experimental and control groups. Unpaired’t’ test to test the significant difference in the knowledge between experimental and control groups. χ2 test is applied to measure the association between the post test level of knowledge of experimental and control group and selected demographic variables.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMAN OR ANIMALS?

Yes, Structured teaching programme will be given to the staff nurses.

7.4 HAS THE ETHICAL CLEARENCE WILL BE SOUGHT FROM YOUR INSTITUTION IN CASE OF THE ABOVE.

1. The ethical clearance will be sought from the research committee of Acharya College of Nursing.

2. Written permission will be obtained from concerned authority.

3. Permission will be obtained from nurses who are involved in the study before collecting the data.

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