Efficacy of spiritual care therapy in patients undergoing percutaneous transluminal coronary angioplasty: A randomized controlled clinical study

Komal Dalal; Abhijit Aklujkar; Harminder Singh; Parag Sarve

doi:10.4103/JCPC.JCPC_37_17

ORIGINAL ARTICLE

Year : 2018 | Volume : 7 | Issue : 3 | Page : 100-105

Efficacy of spiritual care therapy in patients undergoing percutaneous transluminal coronary angioplasty: A randomized controlled clinical study

Komal Dalal PGDPC, PGDCRM, MBBS , Abhijit Aklujkar MD, DNB (Cardiology) , Harminder Singh MD, DM , Parag Sarve MS (Clinical Research), BDS
Department of Medical Research, Bhakti Vedanta Hospital and Research Institute, Mumbai, Maharashtra, India

Date of Web Publication

10-Jul-2018

Correspondence Address:
Dr. Komal Dalal
Prof. Spiritual Care, Advisor-Clinical Research, Bhakti Vedanta Hospital and Research Institute, Mira Road, Thane, Mumbai, Maharashtra
India

Source of Support: None, Conflict of Interest: None

Check

DOI: 10.4103/JCPC.JCPC_37_17

Abstract

Background: Spiritual care therapy has been shown to improve the well-being in chronic diseases such as cancer or psychiatric illness. The present study was conducted to evaluate the efficacy of spiritual care in patients with coronary artery disease (CAD) undergoing percutaneous transluminal coronary angioplasty (PTCA). Methods: An open-label, clinical study randomizing patients undergoing PTCA to receive either standard of care alone or spiritual therapy with standard of care was carried out. Spiritual care therapy includes spiritual counseling and holy name chanting before angioplasty and holy name chanting over a period of 14-day postangioplasty. Clinical examination, functional assessment of cancer therapy-general well-being (FACT-G) and functional assessment of chronic illness therapy-spiritual well-being (FACIT-Sp), Hospital Anxiety and Depression Scale (HADS) were performed before the procedure, 24 h and 14 days after PTCA. Inferential statistics was used to assess the statistical significance of the outcome measures. Results: Significant reductions in the systolic blood pressures, FACT-G and FACIT-Sp were observed at both 24 h and 14 days following angioplasty in the spiritual care group but not in the control group that received standard of care. Significant reduction in the anxiety and depression scores of HADS in the spiritual care group was also observed as compared to control group at both the follow-up periods. Furthermore, a significant shorter length of hospital stay and lower levels of high-sensitivity C-reactive protein was observed in the spiritual group.
Conclusion: Spiritual care therapy can be part of treatments regime among CAD patients undergoing PTCA as it improves general as well as spiritual well-being and reduces hospital anxiety.

Keywords: Angioplasty, cardiac patients, spiritual care

How to cite this article:
Dalal K, Aklujkar A, Singh H, Sarve P. Efficacy of spiritual care therapy in patients undergoing percutaneous transluminal coronary angioplasty: A randomized controlled clinical study. J Clin Prev Cardiol 2018;7:100-5

How to cite this URL:
Dalal K, Aklujkar A, Singh H, Sarve P. Efficacy of spiritual care therapy in patients undergoing percutaneous transluminal coronary angioplasty: A randomized controlled clinical study. J Clin Prev Cardiol [serial online] 2018 [cited 2023 Jun 8];7:100-5. Available from: https://www.jcpconline.org/text.asp?2018/7/3/100/236329

Introduction

The World Health Organization defines health as “a state of complete physical, mental, and social and spiritual well-being and not merely absence of disease or infirmity.”^[1] However, spiritual well-being has been least focused in general. Spiritual care has been expanded, more varied and well differentiated from the contemporary practice of religious care in a modern system of medicine.^[2] A paradigm shift has been observed in the Western culture moving from materialistic view to positivism.^[3] Even in ancient medicine, healing practices through spirituality have been proven to maintain a healthy lifestyle in individuals with disease states.^[4] Spiritual care therapy has been shown to enhance the neuroplasticity and facilitates neurotransmission, thus reducing the symptoms and signs of psychiatric morbidities such as depression and anxiety.^[5],[6],[7]

Patients with coronary artery disease (CAD) are at increased risk of mental illness.^[8] In addition, a significant risk of anxiety and depression is observed in patients undergoing elective percutaneous transluminal coronary angioplasty (PTCA) for the management of CAD.^[9] Population at high risk of anxiety following PTCA includes women, type D personality, above 70 years of age, and patients with angiographically normal arteries.^[10],[11] Anxiety and depression negatively influence the outcomes following PTCA.^[12] Spiritual care therapy in our earlier studies has been shown to reduce apprehension, anxiety, and depression and improve the sense of well-being in cancer and psychiatric patients.^[13],[14] Hence, we carried out the present study to assess the efficacy of adjuvant spiritual care therapy in patients undergoing PTCA in comparison to standard of care alone.

Methods

Study ethics and design

The study was carried out after obtaining approval from the Institutional Ethics Committee and informed consent from all the study participants. The study was a prospective, parallel, randomized controlled, and open-label clinical study conducted between November 2015 and March 2017.

Study procedure

Patients of either sex, between age 18–75 years diagnosed with CAD and undergoing planned angioplasty were randomized by computer-generated random sequence to receive either spiritual care therapy as an add-on to the standard of care or standard of care alone. The allocation of participants to the interventional arms was concealed using sequentially numbered, opaque, and sealed envelopes. The intervention was validated spiritual care and both groups received medical treatment as advised by the consultant cardiologist. Our institute is a multispecialty tertiary care hospital with a dedicated team providing spiritual care that includes qualified spiritual counselors and a spiritual care assistant. Spiritual care was given under MATCH guidelines (M–MERCY, A–AUSTERITY, T–TRUTHFULNESS, C–CLEANLINESS, and H– HOLY NAME) that were validated previously in the same set-up, especially in patients with psychiatric morbidities and cancer.^[13],[14]

The principles of the Bhaktivedanta Hospital model for spiritual care are based on the following:

No discrimination on the basis of religion, sex, age, or belief in god
Accepting the common broad principles of all major religions
Care is manifested through environment such as vegetarian, wholesome food, spiritual sound vibration, and emotional care.

The spiritual care was given to all study participants of the interventional group in addition to the routine standard care. Participants were counseled on the basis of MATCH guidelines for 30 min by spiritual counselor and requested to hear holy name “Hare Krishna Mahamantra” chanting for 30 min before undergoing angioplasty procedures. The patient was also asked to hear holy name chanting two times every day for 30 min for 14-day postprocedures. Control group participants received only the routine standard care. General well-being of the participants was assessed using functional assessment of cancer therapy (FACT-G) and spiritual well-being with functional assessment of chronic illness therapy-spiritual well-being (FACIT-Sp-12).^[15],[16] Anxiety and depression evaluation included assessment with Hospital Anxiety and Depression Scale (HADS).^[17] All the assessments were carried out before angioplasty, 24 h postangioplasty and 14 days after the intervention for both groups. Systolic and diastolic blood pressures were measured pre- and post-spiritual care therapy in spiritual group at above define a timeline. Inflammatory markers, laboratory investigation, erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (hs-CRP) were carried out before angioplasty procedure and 14 days' postangioplasty for both groups.

Statistical analysis

The categorical variables were analyzed by proportions and the numerical variables were assessed for their distribution using Kolmogorov–Smirnov test. Those with normal distribution were assessed using parametric tests and nonparametric tests were used to analyze data following other distributions. Repeated measures ANOVA were used to analyze the numerical variables at preinterventional, 24 h after the intervention and 14-day postintervention. Considering the absence of prior data on the effect estimates of spiritual care in the population undergoing angioplasty, we did not attempt sample size calculation for this study. P < 0.05 was considered statistically significant. Random sequence was generated by random number table by the trial statistician, and the allocation was concealed using sequentially numbered opaque envelopes.

Results

Demographic details

A total of 50 participants (39 men and 11 women) were enrolled, randomized, and were included for the final analysis in each group. Mean (standard deviation) age (years) in the spiritual care group was 58.7 (10.8) and 59.4 (9.7) in the control group.

Change in scores

Baseline, 24 h and 14 days values of various clinical parameters and scores (including their individual domains) between the groups are depicted in [Table 1]. All parameters were evaluated at two levels: first within spiritual care group and second comparison between spiritual care group and control group.

Table 1: Clinical and laboratory parameters of the study participants

Click here to view

Baseline

No significant difference in any of the clinical or laboratory or scoring parameters was observed between the groups except for lower scores of FACT-G physical well-being component was seen in the control group. As the study was randomized, this difference shall be ignored and might have arisen by chance.

At the time of discharge

In the spiritual care group, comparative systolic (mean 131 vs. mean 124, P = 0.01) and diastolic blood pressures (mean 78 vs. mean 74, P = 0.04) before and after spiritual care therapy were observed to be statistically lower than comparative systolic and diastolic blood pressures in preoperative period. Furthermore, average postinterventional systolic and diastolic blood pressures at the time of discharge were significantly better than preinterventional values. However, no significant difference was observed between the spiritual care and control groups on the same (P > 0.05). With regards to the scoring systems, within spiritual care group, compared to preoperative period, overall FACT-G (mean score 87 vs. mean score 63, P = 0.0001) and FACIT-Sp (mean score 41 vs. mean score 30, P = 0.0001) scores in all the domains were significantly better at the time of discharge. Similarly, spiritual care group had significantly better improvement in FACT-G (P = 0.0001) and FACIT-Sp (P = 0.0001) scores compared to control group. In addition, in the spiritual care group, both HADS depression (mean score 6 vs. mean score 9) and HADS anxiety scores (mean score 6 vs. mean score 11) were considerably lower at discharge than the preoperative period. Furthermore, both HADS depressions score (P = 0.0001) and HADS anxiety score (P = 0.0001) were significantly lower in spiritual group than control group.

The length of hospital stay was observed to be significantly shorter in the spiritual care than the control group (mean days 2 vs. mean days 4, P = 0.01).

Day 14 postintervention

On day 14, in the spiritual care group, systolic and diastolic blood pressures before the spiritual care therapy were significantly lower than a preoperative period, but no such significant differences were observed with the control group. Similarly, both systolic blood pressure (mean 131 vs. mean 124 vs. mean 124, P = 0.02^b) and diastolic blood pressures (mean 78 vs. mean 74 vs. mean 96, P = 0.3^b) postspiritual care therapy on day 14 were significantly better than the pretherapy values as compared to the values at the time of discharge and in the preoperative period. However, no significant changes were observed between the spiritual and control groups (P > 0.05). In the spiritual care group, both the overall and all the domains of FACT-G (mean score 67 vs. mean score 87 vs. mean score 91, P = 0.0001) and FACIT-Sp (mean score 30 vs. mean score 41 vs. mean score 41, P = 0.0001) were significantly better on day 14 than the preoperative values and the scores at the time of discharge. Furthermore, all the above-mentioned scores were significantly better in the spiritual care group compared to control group of participants (P = 0.0001). Significant reduction in HADS anxiety score (mean score 11 vs. 6 vs. 4, P = 0.0001) and HADS depression score (mean score 10 vs. 6 vs. 5, P = 0.0001) were observed in the spiritual group from preoperative, discharge and day 14 follow-up. HADS anxiety (P = 0.0001) and HADS depression (P = 0.002) scores were significantly reduced in the spiritual group as compared to control group. ESR was observed to be significantly raised and hs-CRP was observed to be significantly lowered (P = 0.3) in the spiritual care therapy compared to preoperative values. However, the only hs-CRP level was significantly better in the control group than spiritual care group on day 14.

Discussion

We carried out the present study to assess the efficacy of adjuvant spiritual care therapy in patients undergoing PTCA in comparison to the standard of care alone. Administration of spiritual care significantly improves general well-being, spiritual well-being, anxiety, and depression scores in patients with angioplasty. In addition, significant improvement in blood pressure pre- and post-spiritual therapy, hs-CRP levels, and shorter hospital stay were also observed with spiritual care therapy in comparison to control group.

Hospice spiritual care has been shown to improve the caregiving outcomes while reducing the end-of-life symptoms related distress.^[18] PTCA has been shown to be associated with a significant increase in the stress level to those who are undergoing the procedure due to both the invasive nature of the procedure as well as the change in the lifestyle required for appropriate treatment of underlying CAD.^[19] Due to an increased stress, there is an increased risk of myocardial infarction thus onus rests with the treating physicians.^[20] Lenzen et al.^[21] reported significant anxiety in a patient who underwent angioplasty as well as repeat angioplasty. The authors of the same study also observed a decrease in the well-being of the patients undergoing repeat angioplasty. In addition, Edéll-Gustafsson and Hetta ^[22] also found that PTCA patients had significant anxiety and mood disturbance even after 1 year following the intervention. The anxiety level in PTCA patients was higher, and their perception on social support was lower compared to patients undergoing coronary artery bypass grafting. Székely et al.^[23] found that anxiety in patients undergoing PTCA is directly associated with mortality. Sharif et al.^[24] assessed the impact of discussing self-care plan at discharge in patients undergoing PTCA and observed a positive impact on the stress, anxiety, and depression levels.

We observed that those who received spiritual care had a reduction in the hospital length of stay by nearly half than the control group thus discounting the hospital cost for the patients. Future studies should be directed in evaluating cost-effectiveness of spiritual care therapy in a varied spectrum of disease conditions.

Several discrepancies were observed in the perception of spirituality, spiritual distress, and spiritual care provided to patients in a study from Canada.^[25] The strength of this study is that a well-validated spiritual care therapy was evaluated. The study is limited with short duration of follow-up of the study participants; the assessments were not blinded; we did not include patients who have undergone emergency PTCA due to ethical concerns; cost-effectiveness of the intervention was not assessed although use of FACT-G has been well documented in chronic illness more specific assessment questionnaire such as psychological general well-being index may be preferred. The present literature in cardiology mentioned changes in ESR and hs-CRP are truly reflective of chronic inflammation and are evident only after 6 weeks of therapy but the present study was carried out with only 14 days of follow-up of the study participants, so changes in ESR and hs-CRP are expected to nonsignificant though lower level of hs-CRP was observed in spiritual group.

Conclusion

Limitation of present study are small sample size and shorter spiritual care therapy follow-up duration. Study is limited to establish correlation between spiritual care and chronic inflammatory parameters due to shorter follow up duration. To conclude, our spiritual care model in addition to standard of care significantly improves the physical, emotional, social, functional, and spiritual well-being, most importantly reduces anxiety of the patients undergoing PTCA. Spiritual therapy model has demonstrated shorter hospital stay following PTCA procedure. However, large multicentric controlled trials with longer follow-up of the study participants are required to confirm the findings of this study.

Acknowledgment

We would like to thank the Hospital Management of Bhaktivedanta Hospital and Research Institute.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1.	Kannan S, Gowri S. Spiritual care: Define and redefine self. J Relig Health 2016. Available from: https://link.springer.com/article/10.1007%2Fs10943-016-0269-9. [Last accessed on 2017 Apr 17].
2.	Spirituality in the Practice of Care. Available from: http://www.spiritualcare.ca/flow/uploads/pdfs/Spirituality_in_Practice_of_Care1.pdf. [Last accessed on 2017 Apr 17].
3.	Culliford L. Spiritual care and psychiatric treatment: An introduction. Adv Psychiatr Treat 2002;8:249-58.
4.	Griffith JL, Norris L. Distinguishing spiritual, psychological and psychiatric issues in palliative care: Their overlap and differences. Prog Palliat Care 2012;20:79-85.
5.	Meraviglia M. Effects of spirituality in breast cancer survivors. Oncol Nurs Forum 2006;33:E1-7.
6.	Davis B. Mediators of the relationship between hope and well-being in older adults. Clin Nurs Res 2005;14:253-72.
7.	Datta NU, Nandan D. Importance of spiritual health in public health systems of India. Health Popul Perspect Issues 2008;31:204-8.
8.	Borkowska A, Pulkowska J, Pulkowski G, Rybakowski F. Association of temperament, character and depressive symptoms with clinical features of the ischaemic heart disease. Wiad Lek 2007;60:209-14.
9.	Astin F, Jones K, Thompson DR. Prevalence and patterns of anxiety and depression in patients undergoing elective percutaneous transluminal coronary angioplasty. Heart Lung 2005;34:393-401.
10.	Qiu YG, Zheng LR, Chen JZ, Zhu JH, Zhang FR, Xu Y,et al. Psychologic status and their influencing factors in patients suspected of coronary disease before and after coronary catheterization. Zhonghua Liu Xing Bing Xue Za Zhi 2003;24:224-8.
11.	Pedersen SS, Denollet J, van Gestel YR, Serruys PW, van Domburg RT. Clustering of psychosocial risk factors enhances the risk of depressive symptoms 12-months post percutaneous coronary intervention. Eur J Cardiovasc Prev Rehabil 2008;15:203-9.
12.	Mayou RA, Gill D, Thompson DR, Day A, Hicks N, Volmink J,et al. Depression and anxiety as predictors of outcome after myocardial infarction. Psychosom Med 2000;62:212-9.
13.	Sankhe A, Dalal K, Save D, Sarve P. Evaluation of the effect of spiritual care on patients with generalized anxiety and depression: A randomized controlled study. Psychol Health Med 2017;22:1186-91.
14.	Sankhe A, Dalal K, Agarwal V, Sarve P. Spiritual care therapy on quality of life in cancer patients and their caregivers: A Prospective non-randomized single-cohort study. J Relig Health 2017;56:725-31.
15.	Yost KJ, Thompson CA, Eton DT, Allmer C, Ehlers SL, Habermann TM,et al. The functional assessment of cancer therapy-general (FACT-G) is valid for monitoring quality of life in patients with non-Hodgkin lymphoma. Leuk Lymphoma 2013;54:290-7.
16.	Webster K, Cella D, Yost K. The functional assessment of chronic illness therapy (FACIT) measurement system: Properties, applications, and interpretation. Health Qual Life Outcomes 2003;1:79.
17.	Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361-70.
18.	Candrian C, Tate C, Broadfoot K, Tsantes A, Matlock D, Kutner J,et al. Designing effective interactions for concordance around end-of-life care decisions: Lessons from hospice admission nurses. Behav Sci (Basel) 2017;7. pii: E22.
19.	Gallagher R, Trotter R, Donoghue J. Preprocedural concerns and anxiety assessment in patients undergoing coronary angiography and percutaneous coronary interventions. Eur J Cardiovasc Nurs 2010;9:38-44.
20.	Dehdari T, Heidarnia A, Ramezankhani A, Sadeghian S, Ghofranipour F, et al. Anxiety, self effi cacy expectation and social support in patients after coronary angioplasty and coronary bypass. Iran J Public Health 2008;37:119-25. Available from: http://ijph.tums.ac.ir/index.php/ijph/article/view/2024. [Last accessed on 2017 Apr 17].
21.	Lenzen MJ, Gamel CJ, Immink AW. Anxiety and well-being in first-time coronary angioplasty patients and repeaters. Eur J Cardiovasc Nurs 2002;1:195-201.
22.	Edéll-Gustafsson UM, Hetta JE. Fragmented sleep and tiredness in males and females one year after percutaneous transluminal coronary angioplasty (PTCA). J Adv Nurs 2001;34:203-11.
23.	Székely A, Balog P, Benkö E, Breuer T, Székely J, Kertai MD,et al. Anxiety predicts mortality and morbidity after coronary artery and valve surgery – A 4-year follow-up study. Psychosom Med 2007;69:625-31.
24.	Sharif F, Moshkelgosha F, Molazem Z, Najafi Kalyani M, Vossughi M. The effects of discharge plan on stress, anxiety and depression in patients undergoing percutaneous transluminal coronary angioplasty: A randomized controlled trial. Int J Community Based Nurs Midwifery 2014;2:60-8.
25.	Selby D, Seccaraccia D, Huth J, Kurppa K, Fitch M. Patient versus health care provider perspectives on spirituality and spiritual care: The potential to miss the moment. Ann Palliat Med 2017;6:143-52.