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CTRI Number  CTRI/2021/11/037970 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On: 03/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Caring for Healthcare Professionals 
Scientific Title of Study
Modification(s)  
Caring for Healthcare Professionals on COVID-19 duty – A Pilot study of an Online Yoga Program in Healthcare Professionals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavita D Chandwani 
Designation  Head of Department 
Affiliation  Department of Research & Development,The Yoga Institute 
Address  Shri Yogendra Marg Prabhat Colony Santacruz East Mumbai

Mumbai (Suburban)
MAHARASHTRA
400055
India 
Phone    
Fax    
Email  research@theyogainstitute.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavita D Chandwani 
Designation  Head of Department 
Affiliation  Department of Research & Development,The Yoga Institute 
Address  Shri Yogendra Marg Prabhat Colony Santacruz East Mumbai

Mumbai (Suburban)
MAHARASHTRA
400055
India 
Phone    
Fax    
Email  research@theyogainstitute.org  
 
Details of Contact Person
Public Query
 
Name  Dr Kavita D Chandwani 
Designation  Head of Department 
Affiliation  Department of Research and Development,The Yoga Institute 
Address  Shri Yogendra Marg Prabhat Colony Santacruz East Mumbai

Mumbai (Suburban)
MAHARASHTRA
400055
India 
Phone    
Fax    
Email  research@theyogainstitute.org  
 
Source of Monetary or Material Support  
Ministry of Science Technology Department of Science Technology KIRAN Division 
 
Primary Sponsor  
Name  Ministry of Science Technology Department of Science Technology KIRAN Division 
Address  Technology Bhawan, New Mehrauli Road New Delhi 110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandrakiran D Hathial  GGMC and JJH  Byculla, Mumbai-400008
Mumbai (Suburban)
MAHARASHTRA 
9820096941

kirangmc85@yahoo.co.in 
Dr Mukta P Bidikar  HBT Medical College and RN Cooper Hospital  HBT Medical College & Dr RN Cooper Hospital, U 15, Bhaktivedanta Swami Rd, JVPD Scheme, Juhu Mumbai, Maharashtra 400056
Mumbai (Suburban)
MAHARASHTRA 
9821734441

bidikarmukta@gmail.com 
Dr Madhumita Bhattacharjee  Lilavati Hospital & Research Centre  A791 Bandra
Mumbai (Suburban)
MAHARASHTRA 
2226568203

research.lilavati@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee for Biomedical & Health Research  Approved 
HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai  Approved 
Institutional Ethics. Committee-GGMC and. JJH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stress, Anxiety, DEpression 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  An Online Yoga program  A one-month long yoga program offered online will be the intervention. It consists of videos and podcasts to be accessed by the participants randomized to the Yoga group. 
Comparator Agent  Wait-list Controls  The Wait-list control participants will not be doing yoga during the one month after consenting to participate in the study. 
 
Inclusion Criteria
Modification(s)  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Physician, Interns and Nurses who were on COVID-19 duty in the last six months
2. Agreeing to follow the study’s intervention and complete assessments
3. Willing to be randomly assigned to either intervention group or wait-list control group
 
 
ExclusionCriteria 
Details  1. Self-reported major psychiatric condition or current history of taking drugs for the same
2. Serious illness of neck, back, pelvis, or lower limbs that will interfere with following the yoga protocol
3. Pregnant or trying to get pregnant in case of female HCPs
4. Participants with severe and uncontrolled chronic disease (Non-communicable disease) such heart disease, hypertension, pulmonary disease, arthritis, diabetes, etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasibility and Acceptance of Yoga program and stress, anxiety and depression  1) Baseline
2) end of Intervention / one-month post
3) three-month post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep duration, Burnout, Mindfulness  1) Baseline
2) end of Intervention / one-month post
3) three-month post intervention 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   22/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   After the data analyses, the results will be sent as manuscript/article to relevant scientific journal/s for publication. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In the current overwhelming situation due to the COVID-19 pandemic, Healthcare Professionals (HCPs) are posed with multiple emergent situations that questions their capability in terms of severity and numbers of severely ill cases in the hospital wards topped by uncertain nature of the virus that has killed millions of persons worldwide. In addition to the above scenario, deaths from COVID-19 infection amongst the HCPs globally, incites a fear of themselves getting infected or transmitting it to their near and dear ones while they impart critical care to COVID-19 patients.

Excessive stress has been reported among the HCPs globally. Such persistent/repeated stressful situations could lead to effects on the individual’s health such as depression, and development of aspects of metabolic syndrome, cardiovascular disease or post-traumatic stress disorder. Practice of yoga, has been shown to reduce stress in various conditions including HCPs exhaustion and burnout.

The purpose of this study is to pilot-test in a randomized controlled design (wait-list controls), the feasibility and acceptance of a tailored flexible online yoga program and its effects on stress, anxiety and depression in HCPs involved in COVID-19 patients’ care. Such an online yoga program could potentially be an effective self-care stress-buster acceptable to HCPs. In this study, the yoga program and the assessments (baseline, one-month and three-month post intervention assessments) will be conducted online without face-to-face interaction, thus removing any risk to the HCPs and the research staff.

 
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