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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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