| 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
|
|
|
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
|
|
|
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. |