Yoga interventions for the management of COVID 19 in asymptomatic patients

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2021/04/032845
• Lead Sponsor: R ARCHANA

Brief Summary

The global impact of Covid19 has been profound and the health threat that it presents to the individual, the national economy and the healthcare delivery systems are estimated to be more serious than most of the other pandemics in the modern times (1). Being a new viral infection, as on date there are no proven preventive or therapeutic regime available. The vaccines or drug regimens are in various stages of evaluation (2). One fundamental principle of Yoga is that the body heals itself and duty of the physician is to aid the self-healing process i.e. salutogenesis. Yoga interventions in a variety of conditions has documented to improve quality of life, reduce mental health related problems such as stress, anxiety & depression in a wide spectrum of illness (3).

The aim of our study is to assess the effect of Yoga intervention on management of depression, anxiety, stress, sleep quality and overall quality of life in asymptomatic COVID19 patients. It is a Quasi Experimental study (Pre post design) with a sample size of 60 COVID19 asymptomatic patients who are part of the Saveetha Home care program of Saveetha Medical College and Hospital. They will be recruited for the study and will be informed about the significance of yoga intervention. Prior to the intervention, the training for yoga practice will be given via Zoom meeting and it will be made sure that the subject has correctly learnt all the steps involved in the intervention. The three-month yoga practice will be given as a video recording and shared in whatsapp group and the patients practice will be monitored in Whatsapp daily, morning and evening for 14days. The pre and post values of depression, anxiety, stress, perceived stress, sleep quality and quality of life will be assessed using google form questionnaires, Quality of life as assessed by WHO-QoL BREF (4), DASS-21 for assessing depression & anxiety (5), PerceivedStress Scale for stress (6), Pittsburgh Sleep Quality Index (PSQI) for sleep (7). The statistical analysis will be done using SPSS 17.0. The pre and post data will be analyzed using paired t test. P values less than 0.05 will be accepted as indicator for significant differences between the data.

The expected outcome of the project is that the Practice of yoga will be effective in reducing stress, anxiety, depression and improving the quality of life and quality of sleep in asymptomatic COVID 19 patients in the saveetha home care system.

Reference:

1.Ferguson, N. M., Laydon, D., Nedjati-Gilani, G., Imai, N., Ainslie, K., Baguelin, M., & Dighe, A. (2020). Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand. Imperial College COVID-19 Response Team.

2.Cramer H, Lauche R, Anheyer D, Pilkington K, de Manincor M, Dobos G, Ward L. Yoga for anxiety: A systematic review and metaâ€analysis of randomized controlled trials. Depression and anxiety. 2018 Sep;35(9):830-43.

3.Thanalakshmi J, Maheshkumar K, Kannan R, Sundareswaran L, Venugopal V, Poonguzhali S. Effect of Sheetali pranayama on cardiac autonomic function among patients with primary hypertension-A randomized controlled trial. Complementary Therapies in Clinical Practice. 2020 Mar 5:101138.

4.World Health Organization. Division of Mental Health. (‎1996)‎. WHOQOL-BREF : introduction, administration, scoring and generic version of the assessment : field trial version, December 1996. World Health Organization

5.Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety & Stress Scales. (2nd Ed.)Sydney: Psychology Foundation.

6.Cohen, S., Kamarck, T., and Mermelstein, R.(1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396.

7.Buysse DJ, Reynolds III CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry research. 1989;28(2):193–213.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-13
• Study Start: 2021-08-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All willing Male and Female adult patients ≥18 years and ≤60 years of age at the time of recruitment.

Exclusion Criteria

Explicit non-willingness to be a part of the research study Patients with Severe Acute respiratory Distress syndrome and who were already practicing yoga or meditation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Information on whether Yoga intervention have any impact of COVID 19 patients in terms of reduction of symptoms, and reduction in mental stress, anxiety or depression	3 months

Secondary Outcome Measures

Name	Time	Method
Preliminary results from this exploratory study may provide evidence for future confirmatory research studies.

Trial Locations

Locations (1)

SAVEETHA MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Chennai, TAMIL NADU, India

SAVEETHA MEDICAL COLLEGE AND HOSPITAL

🇮🇳Chennai, TAMIL NADU, India

R Archana

Principal investigator

9840608149

dr.rarchana@gmail.com