| CTRI Number |
CTRI/2021/09/036611 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Yoga on healthcare professionals burnout during COVID-19 pandemic |
|
Scientific Title of Study
|
Effect of Yoga on burnout in Health-Care Professionals working during COVID-19 pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor, Dept. of Cardiology & Professor In-charge, Center for Integrative Medicine and Research |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Center for Integrative Medicine and Research (CIMR), Room No: 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, South West DELHI 110029 India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor, Dept. of Cardiology & Professor In-charge, Center for Integrative Medicine and Research |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Center for Integrative Medicine and Research (CIMR), Room No: 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, South West DELHI 110029 India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor, Dept. of Cardiology & Professor In-charge, Center for Integrative Medicine and Research |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Center for Integrative Medicine and Research (CIMR), Room No: 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, South West DELHI 110029 India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gautam Sharma |
All India Institute of Medical Sciences, New Delhi |
Center for Integrative Medicine and Research (CIMR), Room No 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 South West DELHI |
01126549326
drgautamsharma12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
None |
| Intervention |
YOGA |
Specifically designed yoga protocol will be used. Total 6 online yoga sessions (3 training session in week-1, and 3 followup sessions once in 10 days between week-2 to week-6) will be conducted. Participants will also be encouraged to practice yoga regularly till the end of follow-up period (6 weeks). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthcare professionals (including consultants, residents, nurses, nursing assistants, therapists & technicians) working during the COVID-19 pandemic who are directly exposed to patients (regular physical contact with patients) for at least the past one month.
2. Willingness and ability to practice specifically designed yoga protocol, comply with trial and follow-up procedures. |
|
| ExclusionCriteria |
| Details |
1. Denied informed consent.
2. Pregnant women.
3. Currently enrolled in any other trial.
4. Healthcare professionals with current/recent COVID-19 infection within the past one month, and/or with severe COVID-19 sequelae.
5. Already practicing yoga for more than the last one month or taking any other behavioral/psychological interventions.
6. Any significant condition or co-morbidity that clinicians deem unfit for participation in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in average score of Copenhagen Burnout Inventory (CBI) |
Baseline, and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in total score of Depression, Anxiety, Stress Scale (DASS-21) |
Baseline, and 6 weeks |
| Change in total score of Insomnia Severity Index (ISI) |
Baseline, and 6 weeks |
| Change in total score of PTSD Checklist for DSM-5 (PCL-5) |
Baseline, and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Burnout is one main factor that tends to reduce the performance quality among hospital staff, particularly among doctors had been shown to cause increased medical errors which can lead to decreased patient satisfaction and thus increases the chances of litigation. In personal life, there are increased chances of depression possibly leading to substance abuse and/or deterioration in interpersonal relationship. The first wave of the COVID-19 pandemic was associated with high incidence of anxiety, stress, sleep problems, depression, and post-traumatic stress disorder in health-care workers. With successive waves of contagion that are continually challenging health care systems, more insidious mental health problems such as burnout have also emerged. Our proposed study is a single-arm pre-post clinical trial to estimate the effect of yoga on burnout in healthcare professionals during COVID-19 pandemic. Eligible healthcare professionals working at All India Institute of Medical Sciences (AIIMS, New Delhi), during the COVID-19 pandemic, will be recruited for the study. Total sample size n=82. Specifically designed yoga protocol will be used for the current study. Total 6 online yoga sessions (3 training session in week-1, and 3 follow-up sessions once in 10 days between week-2 to week-6) will be conducted. Participants will also be encouraged to practice yoga regularly till the end of follow-up period (6 weeks). We will also estimate the effect of yoga on stress, anxiety, depression, insomnia, post-traumatic stress disorder symptoms in healthcare professionals. Primary Outcome: Change in the average score of the Copenhagen Burnout Inventory (CBI) at 6 weeks Secondary Outcome: (i) Change in the total score of Depression, Anxiety, Stress Scale (DASS-21) at 6 weeks, (ii) Change in the total score of Insomnia Severity Index (ISI) at 6 weeks, and (iii) Change in the total score of PTSD Checklist for DSM-5 (PCL-5) at 6 weeks. |