Abstract
Introduction: Heart rhythm management devices save patients’ lives. However, they may cause problems with the patient’s perspective of their body image. Therefore, given the significance of the heart function and cardiac rehabilitation, this study was conducted to investigate and compare the effect of the cardiac rehabilitation program on adjustment and body image among patients who use heart rhythm management devices.
Methods: This two-group clinical trial was conducted with 100 patients who used various heart rhythm management devices. The patients were randomly assigned into either the control group or intervention group (50 patients in each group) via four triad blocks. The intervention was 16 sessions of the cardiac rehabilitation program and 4 telephone follow-ups over twelve weeks. Data was gathered before the intervention and both eight and twelve weeks after the intervention using the psychosocial adjustment to illness scale and the body image and relationships scale.
Findings: The majority of the patients were male and in the age range of 40-60 years. Before the intervention, no statistically significant differences were reported between the groups in terms of adjustment control = 68.13 ± 9.1, intervention = 67.13 ± 4.6) and body image (control = 93.14 ± 8.5, intervention = 91.16 ± 8.4) (P>0.5). However, in the intervention group, with each of three devices (pacemaker, ICD, CRT), significant improvements were observed in all aspects of adjustment (16.7 ± 9.3, 25.3 ± 9.5, 20.6 ± 10.3) and body image (45.50 ± 9.80, 55.10 ± 8.80, 42.90 ± 6.10) over time respectively (P<0.001).
Conclusion: The effectiveness of the cardiac rehabilitation program in improving the body image was reported in this study. Therefore, the cardiac rehabilitation program can have a vital role in improving body image and adjustment among patients who use various cardiac rhythm management devices.
Cardiovascular diseases (CVD) consist of a wide range of diseases. They are often chronological and affect individual’s quality of life in physical, mental, social and professional aspects.1 About 50% of deaths are related to stroke and caused by dysrhythmia. A major part of the treatment for CVDs are performed through medications and diet. Many patients prefer to use heart rhythm management devices to control and cure heart dysrhythmia. Heart rhythm management devices produce the impulse, diagnose deadly tachycardia and fibrillation attacks and suppress them.2–3 They include permanent pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronized therapy (CRT).4 While these devices work as patients’ life savers, they may cause psychological tensions,5 social limitations,6 and restrictions to their lifestyle. The main psychological problems experienced by these patients are stress disorders, depression,7 and physical and mental disorders. In addition, some studies indicated that implanting and operating these devices can lead to changes in body image8–10 and adjustment7,11 which can further influence the patients’ quality of life.12,13 Therefore, given the importance of heart function in the body, the expenses of the device, tolerating a foreign object in body,14 and increasing the chance of death,15,16 some specific advice is necessary. The interferences must be aligned with teaching, caring for, and supporting patients.2
The cardiac rehabilitation program is one of the best methods of secondary prevention in patients with cardiac diseases. Such a program results in remarkable improvements in psychological and social symptoms, sexual functions, and quality of life.17 Given that patients must use heart rhythm management devices, creating adjustment and improving their body image therefore is necessary.18–19 Therefore, this study aimed to compare the effect of the cardiac rehabilitation program on the adjustment and body image among patients who used heart rhythm administrating devices.
Methods
Design and Setting
This clinical trial was conducted with two control and intervention groups. The intervention was performed in twelve weeks: eight weeks cardiac rehabilitation (twice a week) and four weeks telephone follow ups (once a week). Samples were 100 patients who used the heart rhythm management device referred to two cardiac referral centers for checking their devices’ function and condition. Data were collected before the study, eight weeks and twelve weeks after the intervention.
Sample
The samples were taken from September 2018 to February 2019. The age of the patients ranged from 18 to 70 years. Inclusion criteria were cardiac rhythm management, the use of cardiac device for less than two years, willingness to participate in the study, ability to receive teachings and adhere to the cardiac rehabilitation program, and suffering from no serious physical or mental disorders. Those patients who lost their willingness to continue their collaboration and were absent from more than two sessions of the cardiac rehabilitation program were excluded.
Procedure
After receiving the required permissions from the University’s research council and the cardiac centers to enter the research zone, qualified patients referred to the hospital for inserting heart rhythm management devices were recruited. At the end of a briefing session that explained the goals and procedures of the study, participants signed written consent forms. Then they filled out the demographic information questionnaire, the adjustment to illness scale, and the body image and relationships scale. Four triad blocks were used to randomly assign the patients to the groups.
The intervention was conducted using the cardiac rehabilitation program (sixteen 2-hour sessions during 8 weeks) and telephone follow ups (four times during 4 weeks). The cardiac rehabilitation program was designed and performed specifically for patients with rhythm management devices. Each session consisted of exercise training (training and information covered; the advantages of exercise for patients with rhythm management device, carrying out elbow, shoulder, and respiratory exercises; and designing weekly exercise plan for home exercises), education (consisted of topics on cardiac rhythm management devices and their use, advantages and disadvantages of devices, use factors that must be considered at home and work, patients’ care problems, physical disorders, and device malfunctions and dietary education), and psychological interventions (involved cognitive therapy and education in relaxation techniques). Each session ended by providing a booklet containing the session-specific techniques and content.
Patients were contacted for follow up twice a week through phone interviews. Those in the intervention group were reminded of what they were taught in education sessions, asked to perform elements of the cardiac rehabilitation program, including home exercises, and check off their progress using a checklist. Patients in the control group did not receive cardiac rehabilitation; they completed routine treatment that included device function analysis and programming. They were given an educational handbook at the end of the study.
At the end of the intervention (twelve weeks after the first day of the cardiac rehabilitation program), patients again filled out questionnaires (the adjustment to illness scale and the body image and relationships scale).
Data Collection
Patient’s Demographic Information and Clinical Data Questionnaire
The questionnaire was designed based on information gathered during literature review and experiences of the research team on the application of cardiac devices in patients.20
Psychosocial Adjustment to Illness Scale
The questionnaire included 46 questions in a 4-degree scale from 0 to 3. It had seven domains and questions about healthcare orientation, vocational environment, domestic environment, sexual relationships, extended family relationships, social environment and psychological distress. One study reported the reliability of this questionnaire using the calculation of Cronbach’s alphabet for each domain as 0.84, 0.82, 0.56, 0.85, 0.80, 0.62, 0.83, 0.77, 0.76 and 0.47, respectively. The overall reliability of this scale in this study was reported as 0.63 and for each domain was 0.5, 0.7, 0.7, 0.8, 0.9 and 0.1, respectively. The lowest and highest scores in this scale were 46 and 184, respectively with a lower score indicating more social psychological adjustment.18
Body Image and Relationships Scale
The questionnaire consisted of 32 statements and was composed of three parts as health and strength (12 statements), social hindrances (9 statements), appearance and sexual attraction (11 statements). The responses were in a 5-point scale with a higher score indicating more severe disorder. The total score was reported as 160. Horms et al,21 reported a satisfactory reliability and internal consistency of this scale.
CONSORT Flow Diagram
Data Analysis
Descriptive and inferential statistics were used for data analysis via the SPSS software. Chi-square test and Fisher exact test were used for qualitative variables. The researcher used t test to compare quantitative variables between the groups. The repeated measure test, Mauchly’s test, Greenhouse-Geisser and nonparametric Friedman test were used for between and intra-group comparisons. P<0.05 was considered statistically significant.
Ethical Considerations
This study was approved by the ethics committee affiliated with Shiraz University of Medical Sciences (Code: 93/7128, IRCT: 2014083118982N). The participants signed the informed consent form after receiving explanations about the goals and methods of the study. The patients were explained the anonymity and confidentiality of the study process. They also could withdraw from the study at any time without being penalized.
Results
In this study, 100 patients who used heart rhythm management devices were divided into control and intervention groups. No statistically significant differences were reported between the groups in terms of demographic and medical characteristics (Table 1).
The demographic characteristics of the patients
With respect to the mean of adjustment scores (control=68.13±9.1, intervention=67.13±4.6) and body image (control=93.14±8.5, intervention=91.16±8.4), no statistically significant differences were reported between the groups before the intervention (P>0.05).
Eight and twelve weeks after the intervention, statistically significant improvements were reported in adjustment and body image (P<0.001). In three domains of body image before, eight, and twelve weeks after the intervention the following results were seen, respectively: health and strength (36.8±8.2; 19.3±3.5; 18.7±3.6), social hindrances (22.5±5.1; 13.4±3.7; 13±3.7), appearance and sexual attraction (28.2±5.8; 16.6±4.4; 16.6±4.3).
Regarding adjustment, statistically significant changes were reported in healthcare, vocational, social, and psychological distress environments (P < 0.05). However, in the control group, no statistically significant improvements in adjustment and body image were reported (P> 0.05) (Table 2 & 3).
Adjustment before, eight weeks and twelve weeks after the intervention
Body image, before, eight weeks and twelve weeks after the intervention
Patients in the intervention group experienced a statistically significant improvement with each of the devices (pacemaker, CRT, ICD) in all adjustment fields and body image (P<0.001). This group also had improvements in all aspects of adjustment and body image over time (P<0.001) with all three devices. The patients in the control group did not experience any statistically significant improvements with each of three devices over time (P>0.05) (Table 4).
Mean scores of the adjustment and body image before, 8-weeks, and 12-weeks after the intervention
Discussion
This study aimed to determine the effect of a cardiac rehabilitation program on adjustment and body image among patients who used different heart rhythm management devices. Noteworthy improvements were observed in adjustment and body image of the patients.
The mean of body image (health and strength, social hindrances, appearance and sexual attraction) was different in all three times of measurement. Therefore, time can influence the improving body image. In addition, three dimensions of health and strength, social hindrances, and appearance and sexual attraction had statistically significant differences before and after the intervention. This indicates the positive effects of cardiac rehabilitation on patients’ body image that aligns with the results of other studies.22,13 The majority of patients mentioned a reduction of sexual desire, satisfaction, and activities before the intervention in the domain of appearance and sexual attraction. In the domain of health and strength, most patients complained about feeling abnormal, unhealthy and not having enough ability to do daily activities. These findings are supported by the results of other studies.23–26 After the intervention in the domain of social hindrances comprehensive improvements were observed among patients compared to before the intervention that was not in line with the result of previous studies. However, personality differences may be a reason for such a difference. The other difference between the studies was the different nature of the interventions and number of sessions: some sessions of cardiac rehabilitation and education versus our study’s 20 sessions of cardiac rehabilitation program combined with education and counseling.
The mean scores of different dimensions and the total score of adjustment in the groups were similar before the intervention. After the intervention, the mean of seven adjustment dimensions in the intervention group improved compared to the control group. Significant changes were observed in healthcare, domestic environment, social environment and psychological distress domains were similar to the results of other studies. Lack of significance in other domains may be due to differences in the society of studies and sampling processes. In the present study, seven dimensions of adjustment (healthcare, vocational environment, domestic environment, sexual relationships, extended family relationships, social environment and psychological distress) were compared. Other studies dealt with adjustment in general.12,28,29 Before the intervention, in the domain of vocational environment, most patients imagined that they might not be able to do their desired activities. In domestic dimension, the majority of the patients had problems in relation to their spouses and doing their share of house chore. In sexual relationships domain, most patients experienced the reduction of sexual activity, sexual desire, and relationship with their spouses. In extended family relationships dimension, most patients had problems in communicating with people inside and outside their home. In social environment domain, the majority of the patients reported a decrease in desire for leisure time and recreational activities. In psychological distress domain, most patients felt fear, tension, unrest, stress, sadness and anxiety that were similar to the results of other studies.23–26,29 It is recommended to conduct further studies to explore the mechanisms by which such programs affect and improve all dimensions of adjustment.
In the current study, no statistically significant relationship was observed between demographic information and field diseases and changes in the adjustment and body image. This finding is in line with the results of the study aiming at the investigation of the cardiac rehabilitation program on changes in the body image.12 However, their intervention period was brief compared to our 20 sessions in 8 weeks. Future studies with longitudinal design, which lead to better results, are recommended.
Limitations of the Study
Major limitations of this study were the sample size and the follow-up times. Although the sample size may have been large enough to evaluate psychosocial adjustment and body image, it was too small to compare between groups over time.
Subjects were recruited from hospitals associated with one university; results may not be generalizable to other Iranian patients or more widely to patients with similar characteristics from other regions or countries. Given that body image is a latent variable that requires self-report, further studies are needed about the effects of cardiac rehabilitation on body image in patients with various types of cardiac rhythm management devices, especially those with robust sample sizes and longer durations of cardiac rehabilitation and patient follow up.
Conclusion
According to the findings of this study, the cardiac rehabilitation program improved the adjustment and body image among cardiac patients. Therefore, the cardiac rehabilitation program even in a short term is recommended as one part of the treatment process for improving the adjustment and body image among patients who use various cardiac rhythm management devices.
Implications for Practice
This was the first study in Iran that investigated the effect of the rehabilitation program on the adjustment and body image of patients who used cardiac devices. The cardiac rehabilitation program had a vital role in improving the patients’ psychological and physical adjustment and body image.
Acknowledgments
Researchers are grateful to all patients who participated in this study, as well as the authorities of the Shiraz University of Medical Sciences for financial support.
Footnotes
Disclosure: The authors have declared no conflict of interests related to this study. The authors thank the Shiraz University of Medical Sciences for financial support related to this work.
- Received October 30, 2019.
- Revision received December 27, 2020.
- Revision received July 4, 2021.
- Accepted July 20, 2021.
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