FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.

 
Close