| CTRI Number |
CTRI/2020/09/027842 [Registered on: 16/09/2020] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Teleyoga on health care workers involved in Covid 19 duty |
|
Scientific Title of Study
|
Effect of tele yoga on burnout, mental health and immune markers of Health Care Workers involved in COVID-19 duty: a pilot randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveen K H |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept. of Community Medicine and Family Medicine, AIIMS, Basni phase 2
Jodhpur RAJASTHAN 342005 India |
| Phone |
9980030138 |
| Fax |
|
| Email |
naveenkhdoc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Naveen K H |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept. of Community Medicine and Family Medicine, AIIMS, Basni phase 2
RAJASTHAN 342005 India |
| Phone |
9980030138 |
| Fax |
|
| Email |
naveenkhdoc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Naveen K H |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept. of Community Medicine and Family Medicine, AIIMS, Basni phase 2
RAJASTHAN 342005 India |
| Phone |
9980030138 |
| Fax |
|
| Email |
naveenkhdoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Basni phase 2, Jodhpur-342005, Rajasthan |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Basni phase 2
Jodhpur-342005
Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Naveen K H |
All India Institute of Medical Sciences |
Department of Community Medicine and Family Medicine, Dept of General Medicine, Dept of Biochemistry, Dept. of Endocrinology, Dept. of Anesthesiology. Health care workers (Resident doctors and nursing staff) posted on Covid 19 duty in ICU, Covid ward will be included in the study Jodhpur RAJASTHAN |
9980030138
naveenkhdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health care workers involved in Covid-19 duty at AIIMS Jodhpur |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Tele yoga intervention will not be provided to the control group during the trial period. However at the end of the trial the recorded yoga module will be shared with control group participants and any questions related to yoga practice will be addressed |
| Intervention |
Tele yoga |
Validated yoga protocol developed by SVYASA University will be delivered by trained and experienced yoga teachers through the online platform |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Consenting health care workers involved in Covid-19 duty at AIIMS Jodhpur and willing to practice yoga for 2 months |
|
| ExclusionCriteria |
| Details |
a. Health care workers practicing any type of yoga
b. Health care workers suffering from any known illness
c. Health care workers on any long term medications
d. Health care workers with any contraindication to the practice of the yoga module
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Burn out, sleep quality, mindfulness, depression, anxiety, stress and immune markers |
Baseline and after 2 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Covid-19 pandemic has affected a large segment of global population and brought significant overload on the health care systems across the nations. Health care workers (HCW) form the pillars of any health care system are involved in war mode in tackling this global crisis. Being the corona warriors, they are subjected to various mental health issues like stress, anxiety, depression, poor sleep quality, professional burnout, lower mindfulness and increase in the level of immune markers which may hamper their resistance soon. Hence, to address the health issues and provide support and care, this Teleyoga intervention is being planned, as Yoga is proved beneficial in mitigating the mental and physical health issues. Since, social distancing is an important preventive strategy for Covid-19, yoga will be delivered through virtual mode. In this pilot study 60 consenting HCW will be randomized into Teleyoga intervention group (30 HCWs) and control group (30 HCWs). The intervention group will receive Teleyoga intervention 5 days a week for 2 months. The burnout will be assessed using Stanford Professional fulfilment index, sleep quality by Pittsburg Sleep quality Index, mindfulness by Mindfulness attention awareness scale and depression, anxiety and stress by DASS scale. Blood samples will be collected for assessing, IL-6, TNF alpha, CD4+T lymphocytes and Serum cortisol. The measurements will be done at baseline and at the end of 2 months. |