INTRODUCTION:

Implantation of a cardiac pacemaker is the treatment of choice in severe and/or symptomatic bradycardia. Sinus node dysfunction is the most common indication for permanent pacing, followed by AV node dysfunction^1,2. High-degree atrioventricular block and sick sinus syndrome remain the major indications for implantation of a cardiac pacemaker.

Other indication for cardiac pacing include hypertensive carotid sinus syndrome, neurocardiogenic syncope (vasovagal syncope), long QT syndrome, and sleep apnea. Cardiac pacing today is an accepted and common treatment for patients with bradycardia, with almost 600,000 pacemakers being implanted worldwide annually³. Currently around 15000 pacemakers are being implanted annually in India, in various centers around the country. About 4000 pacemakers are being implanted per year in All India Institute of Medical Sciences (AIIMS), New Delhi. Currently, artificial electrical cardiac pacing is no longer just a way to save patients' lives with atrioventricular blocks, becoming a way to correct heart rhythm disturbances and atrioventricular synchrony⁴. However, the implantation procedures may cause uncommon but potentially life-threatening infective complications, with an incidence rate ranging from 0.5% to 5.2%^5-7. In recent years the importance of health related quality of life (HRQoL) as an outcome measure has increasingly been recognized. This has particular relevance in cardiac pacing because the goal of therapy for most patients with chronic disease is improvement in function, not cure. These measures should be incorporated as one of the primary measures of outcome in the evaluation of new therapies in chronic diseases including cardiac pacing. Doing so, clinicians, patients, policymakers, health care providers, and HRQoL researchers gain experience with these measures⁸.

The term quality of life (QOL) has many definitions. According to the World Health Organization, quality of life is the "individual's perception of their position in life within the cultural context and values that he lives as well as in relation to their goals, expectations, standards and concerns"⁹. Several studies have shown deleterious quality of life after implantation depending on duration of time and other aspects such as gender, age, co morbidities, psychological and sociocultural aspects. Also the pacemaker patients has been seen more prone to depressive disorder and anxiety disorder and there are also physical complications related to implantation procedure¹⁰. Since limited researches has been done regarding knowledge and quality of life of pacemaker patients in India, the present study has been undertaken related to the concerned issues like inappropriate knowledge, misconception and their effects on quality of life (QOL) of patients with pacemaker implantation. The purpose of this study is to assess the knowledge with regard to pacemaker and quality of life among pacemaker patients during early phase (the time period up to three months after pacemaker implantation ) and later phase (the time period more than six months after pacemaker implantation) with a view to develop an information booklet.

METHODS:

A descriptive, Cross sectional survey was applied to assess the knowledge and quality of life of patients after permanent pacemaker implantation who were registered/admitted in Cardiology wards/ Pacemaker Clinic (CN center OPD), during the period from June to December 2014, Department of Cardiology, AIIMS, New Delhi. A total of 100 patients with 50 in each phase of age group > 18 years and those who can understand Hindi or English were enrolled using Purposive sampling whereas patients with NYHA Class IV, COPD, Chronic Liver disease, Chronic Kidney disease and Neurological disorders and Patients in intermediate phase (the time period between three – six months after pacemaker implantation) were excluded from the study. The study has been approved by Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi.

Data Collection Tools and Techniques:

Demographic Profile and Clinical Profile of the patients was collected using a self-developed pretested questionnaire.

Knowledge Questionnaire:

Self-Developed, validated, Structured Knowledge questionnaire comprising of 31 questions was used to assess the knowledge with regard to pacemaker among the patients with permanent pacemaker implantation. The minimum maximum possible KQ (Knowledge questionnaire) score ranges between 0 – 53 where, total knowledge score was classified into 2 categories; Less than adequate (0 – 26) and Adequate (27 – 53). The reliability was tested using test retest method. Cronbach’s alpha: 0.93. This tool was translated in Hindi and translated back to English by Hindi Section, AIIMS.

Quality of Life Assessment:

WHOQOL-BREF was used for Health related QOL assessment. This is an abbreviated 26-item version of the WHOQOL-100 which is Scored in four domains: domain 1: physical health, domain 2: psychological, domain 3: social relations and domain 4: environment; and separate items related to overall perception of quality of life and general health. Higher scores denote higher quality of life. Permission to use the tool was taken from WHO prior data collection.

Data collection Procedure

Figure 1: Data Collection Procedure

Statistical Analysis:

Descriptive statistics i.e. mean, median, percentage and standard deviation were used for selected socio- demographic and clinical variables. Inferential statistics i.e. Chi – square test / Fisher’s exact test was used to compare the categorical variables. Two Sample independent t- test, was used to compare the knowledge score and QOL scores between early and later phase. Pearson correlation was used for association between knowledge score and QOL domain scores. Data analysis was done using BREF Syntax and statistical package STATA 11.2 version. A probability of (p<0.05) was accepted as significant.

RESULTS:

The total of 100 patients (50 in each phase) were enrolled in the study where the mean age of patients was 57.0 ± 14.1 years in early phase and 53.9 ±13.6 years in later phase. Most of the patients were diagnosed with complete heart block. The demographic and clinical profile of patients are shown in table 1 and 2 respectively.

Table 1: Demographic characteristics of patients in early and later phase of pacemaker implantation n= 100

Variables		Early phase (n=50) Mean ± SD	Later phase (n=50) Mean ± SD	p-value
Age^$		57.0 ± 14.1	53.9 ± 13.6	0.26
		Frequency (%)	Frequency (%)
Gender χ²	Male	38 (76)	34 (68)	0.37
Gender χ²	Female	12 (24)	16 (32)	0.37
Place of stay χ²	Rural	20(40)	24 (48)	0.42
Place of stay χ²	Urban	30 (60)	26(52)	0.42
Marital status χ²	Single	5 (10)	7 (14)	0.53
Marital status χ²	Currently married	45 (90)	43(86)	0.53
Types of Family χ²	Nuclear	18 (36)	23 (46)	0.30
Types of Family χ²	Joint	32 (64)	27(54)	0.30
Education status χ²	Up to 10^th	16 (32)	13(26)	0.73
	Up to 12^th	13(26)	11(22)
	Graduate	16 (32)	18(36)
	Postgraduate	5(10)	8 (16)
Occupation χ²	Employed	22 (44)	19 (38)	0.68
	Unemployed	14 (28)	18 (36)
	Retired	14 (28)	13 (26)
Profession ¤	Student	0 (00)	1 (2)	0.29
	House wife	9(18)	10(20)
	Government Service	16(32)	17 (34)
	Private Service	4(8)	6(12)
	Business	612)	1 (2)
	Farmer	8 (16)	4(8)
	Others	7(14)	11 (22)
Monthly income (Rs.) ¤	<1000	5 (10)	6(12)	0.15
	1000 – 5000	15 (30)	17(34)
	5000 – 10000	8(16)	15 (30)
	>10000	22 (44)	12(24)

$= Two Sample independent t test χ²= Chi square test; ¤ = Fisher’s exact test *p<0.05

Table 2: Distribution of patients according to clinical characteristics during early and later phase of pacemaker implantation n = 100

Variables		Early phase (n=50)	Later phase (n=50)	p-value
Variables		Frequency (%)	Frequency (%)
Diagnosis ¤	1° heart block	0 (00)	2(4)	0.05
	2° AV block	4(8)	7 (14)
	CHB	30(60)	24 (48)
	LBBB	4 (8)	9 (18)
	RBBB	3 (6)	6 (12)
	SSS	9 (18)	2(4)
NYHA Class ¤	Class I	19(38)	17 (34)	0.64
	Class II	26(52)	30 (60)
	Class III	5 (10)	3 (6)
Modes of Pacing χ²	Single Chamber	11 (22)	18 (36)	0.12
Modes of Pacing χ²	Dual Chamber	39 (78)	32 (64)	0.12

χ²= Chi square test; ¤ = Fisher’s exact test *p<0.05

Table 4: Correlation between Knowledge score and QOL domain score in early and later phase of pacemaker implantation n = 100

QOL Domains	Early phase (n=50)	Later phase (n=50)
QOL Domains	Knowledge	Knowledge
Overall quality of life	r = 0.01 p = 0.89	r = - 0.03 p = 0.79
General Health	r = - 0.04 p = 0.76	r = - 0.01 p = 0.94
Physical Health	r = 0.32 p = 0.0206*	r = 0.17 p = 0.22
Psychological	r = 0.25 p = 0.07	r = - 0.02 p = 0.89
Social relationships	r = 0.38 p = 0.0052*	r = 0.01 p = 0.94
Environment	r = 0.14 p = 0.31	r = 0.22 p = 0.10

Pearson correlation test, *p< 0.05

Table 5: Association between General health of quality of life and selected variables of patients during early and later phase of pacemaker implantation n = 100

Variables	Categories	Scores of General health
		Early phase (n=50)		Later phase (n=50)
		Mean ± SD	p value	Mean ± SD	p value
Type of family	Nuclear	58.3 ± 27.1	0.0377*	65.2 ± 18.0	0.92
	Joint	71.8 ± 17.6		65.7 ±20.9

Two Sample independent t test, *p<0.05

Table 6: Association between QOL in Physical Health domain and selected variables of patients during early and later phase of pacemaker implantation n = 100

Variables	Categories	Scores of quality of life in physical health domain
		Early phase (n=50)		Later phase (n=50)
		Mean ± SD	p value	Mean ± SD	p value
Place of stay^$	Rural	58.5 ± 12.3	0.67	58.1 ± 11.3	0.0275*
	Urban	60.3 ± 15.6		65.5 ± 11.4
Type of family^$	Nuclear	52.5 ±10.5	0.0075*	60.0 ± 10.8	0.29
	Joint	63.6 ± 14.7		63.6 ±12.6
		Median (min – max)		Median (min – max)
NYHA class^€	I	64.2(21.4 – 92.8)	0.0396*	60.7(42.8 – 92.8)	0.84
	II	64.7(32.1 – 78.5)		60.7(25 – 78.5)
	III	46.4 (35.7 –60.7)		64.2(46.4 – 71.4)

€ = Kruskal Wallis Test; $= Two Sample independent t test, *p<0.05

Table 7: Association between QOL in Psychological Domain and selected variables of patients during early and later phase of pacemaker implantation n= 100

Variables	Categories	Scores of quality of life psychological domain
		Early phase (n=50)		Later phase (n=50)
		Mean ± SD	p value	Mean ± SD	p value
Gender	Male	61.9 ± 13.9	0.0299*	62.0 ± 10.0	0.44
	Female	51.7±13.3		56.5 ±18.1
Place of stay	Rural	57.7 ± 11. 6	0.47	53.2 ± 15.1	0.0092*
	Urban	60.6 ± 15.9		63.9 ± 12.5

Two Sample independent t test, *p<0.05

Table 8: Association between QOL in Environment domain and selected variables of patients during early and later phase of pacemaker implantation n= 100

Variables	Categories	Scores of quality of life Environment domain
		Early phase (n=50)		Later phase (n=50)
		Mean ± SD	p value	Mean + SD	p value
Place of stay^$	Rural	46.2 ± 12.4	0.72	47.2 ± 11.0	0.0018*
	Urban	47.5 ± 12.3		59.6 ±14.8
Type of family^$	Nuclear	43.4 ± 13.3	0.12	49.3 ±12.2	0.0476*
	Joint	49.0 ± 11.4		57.4 ±15.3
Occupation^¥	Employed	46.0 ± 12.1	0.36	46.0 ± 11.8	0.0318* 0.030^b
	Unemployed	44.6 ±12.2		52.4 ± 14.9
	Retired	50.8 ± 12.5		62.2 ± 14.4
		Median (min – max)		Median (min – max)
Marital status^#	Single	40.6(21.8 – 46.8)	0.0475*	46.8(40.6 – 59.3)	0.30
	Currently married	53.1(18.7 -65.6)		56.2 (28.1 -84.2)
Education status^€	Up to 10^th	40.6(18.7 – 62.5)	0.10	46.8(28.1 – 84.3)	0.0153* 0.0072^∞ 0.0074^£
	Up to 12^th	50.0(31.2 – 59.3)		56.2(40.6 – 75)
	Graduate	53.1(18.7 – 65.6)		46.8(28.1 – 78.1)
	Postgraduate	62.5(34.3 – 62.5)		65.6(56.2 – 84.3

# = Wilcoxon ranksum test; € = Kruskal Wallis Test; $= Two Sample independent t test; ¥ = One way Anova corrected with Bonferroni test, *p<0.05 (b = employed vs retired; ∞= up to 10^th vs Postgraduate; £ = graduate vs postgraduate)

In the early phase, male had higher knowledge than female (p = 0.0343), also knowledge had association with occupation (p = 0.0224) and education status (p = 0.0093) whereas in later phase, knowledge showed association with gender (p = 0.0445), place of stay (p = 0.0176) and occupation (p = 0.0174). The finding reported that higher the age higher the QOL in psychological (p = 0.0018) and environment domain (p = 0.0024) during later phase of pacemaker implantation. In terms of QOL, the overall quality of life was associated with monthly income (p = 0.0134), general health with type of family (p = 0.0377), physical health domain with type of family (p = 0.0075) and NYHA class (p = 0.0396), psychological domain with gender (p = 0.0299) and environment domain with marital status (p = 0.0475) during early phase of pacemaker implantation. During later phase, place of stay had an association with physical health (p = 0.0275), psychological (p = 0.0092) and environment domain (p = 0.0018). Again, type of family (p = 0.0476), occupation (p = 0.0318) and education status (p = 0.0153) had association with environment domain of QOL.

Development of an Information Booklet:

Based on the study findings, an informational booklet was developed which focuses mainly on general information about pacemaker, components of pacemaker, lifestyle modifications and self-care activities. It was developed under the guidance of guide and co guides, validated by experts and translated to Hindi with the help of experts from Hindi section, AIIMS. After development of booklet, it was given to the patients to establish their understanding and usefulness of information and was found to be acceptable and useful.

DISCUSSION:

This study revealed a significant difference in knowledge score of pacemaker patients in early and later phase of implantation where majority (60%) had less than adequate knowledge in early phase and most of the patients (64%) had adequate knowledge in later phase. This finding is supported by other similar studies ^(11-14). In the present study, the early phase patients had low QOL in social relationships domain and in environment domain. Mean QOL score of patients was higher in later phase when compared to early phase in social relationships domain and environment domain. The QOL in the physical domain was improved in both the phases. These findings are supported by another study which states quality of life in people with pacemaker is reported to be higher with longer duration after implantation as reported by Vellone E et al¹⁵. Findings also supported in a study by Van Eck JWM et al ¹⁶, where it is concluded in most patients receiving a pacemaker, HRQoL increased in the first year after pacemaker implantation. In this study, there was improved quality of life in social relationships domain in later phase which is similar with the results reported by Kurucová R et al¹⁷but it is in contrast to the same study which showed that patients reported lowest quality of life in psychological and spiritual domains while there was an improved QOL in psychological domain in the present study. In this study, Knowledge had a weak positive correlation with physical health and social relationships domain of QOL in early phase which is in line with the findings by El-Dein GAG et al¹⁸. The strengths of the present study are that it is concerned with early and later phase of pacemaker implantation with regard to assessment of knowledge and quality of life. Furthermore, standardized tool was used to assess quality of life and an information material was developed based on the findings. Limitations of the study identified were, it was conducted in a single- center which limits the generalizability. Purposive sampling method was used. Also, knowledge was assessed using self-developed questionnaire. Implications of this study are: 1) Routine assessment of quality of life of patients before and after implantation of pacemaker can be done. 2) Development of educational intervention and discharge counselling services for pacemaker patients regarding home care management and follow up teaching session in OPD can be organized by nurses to prevent the complications thus improving the QOL of patients. 3) Institution should emphasize the development of competent nurse practitioner with specific focus on pacemaker care. 4) Video teaching programme based on study findings can be developed and displayed in the OPD. 5) Further, research can be undertaken with large sample size, in a multi – centered setting or on a different demographic and geographic areas.

CONCLUSION:

Quality of life assessment of patients after permanent pacemaker implantation in clinical practice can help nurses to understand better the disease and treatment effect on one’s life, and to understand the preferences, expectations and requirements associated with the disease. Knowledge among the patients affect their quality of life after pacemaker implantation. The study findings support the need to have an educational intervention for patients in order to improve their knowledge with regard to pacemaker resulting into positive self-care attitude and improvement of quality of life. Thus, development of an information booklet for these patients will help them to improve their self-care activities while preventing further complications.

FUNDING:
Nil.

CONFLICT OF INTEREST:

None declared.

ACKNOWLEDGEMENT:

Authors thanks the WHO for providing permission to use WHOQOL-BREF Questionnaire for the purpose of the study.

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Received on 10.10.2016 Modified on 15.11.2016

Asian J. Nur. Edu. and Research.2017; 7(1): 108-114.

DOI: 10.5958/2349-2996.2017.00022.2

Variables	Min – Max possible score	Early phase (n=50)	Later phase (n=50)	p-value
Variables	Min – Max possible score	Mean ± SD	Mean ± SD	p-value
Total Knowledge Score	0 – 53	24.8 ± 9.5	29.8 ± 8.6	0.008*