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CTRI Number  CTRI/2020/07/026301 [Registered on: 01/07/2020] Trial Registered Prospectively
Last Modified On: 01/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Role of Yoga in deStressing HCWs in COVID-19 : A RCT 
Scientific Title of Study   Role of Yoga in de Stressing Health Care Personnel during COVID 19 Pandemic : A Randomised control Trial from a Tertiary Care Centre in North India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhanu Duggal 
Designation  Head of Department, Cardiology 
Affiliation  AIIMS, Rishikesh 
Address  Department of Cardiology,AIIMS Rishikesh, PIN : 249203

Dehradun
UTTARANCHAL
249203
India 
Phone  9084074900  
Fax    
Email  bhanuduggal2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhanu Duggal 
Designation  Head of Department, Cardiology 
Affiliation  AIIMS, Rishikesh 
Address  Department of Cardiology,AIIMS Rishikesh, PIN : 249203


UTTARANCHAL
249203
India 
Phone  9084074900  
Fax    
Email  bhanuduggal2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhanu Duggal 
Designation  HoD, Cardiology 
Affiliation  Professor and HoD Department of Cardiology, AIIMS, Rishikesh 
Address  Department of cardiology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  9869418148  
Fax    
Email  bhanuduggal2@gmail.com  
 
Source of Monetary or Material Support  
AIIMS RISHIKESH 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  AIIMS Rishikesh Dist- Dehradun Uttaranchal PIN- 249203 
Type of Sponsor  Research institution and hospital 
 
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 
Prof ravi Kant  AIIMS Rishikesh  Director, AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 9868218536

dir@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  health care personnel during COVID 19 pandemic  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo 
Intervention  Yoga  Suksham vyayam-05 min Yogasana -30 min Deep Relaxation in Shavasana-10 min Pranayam-10min Total duration of study - 04 months Dhyan -05 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All healthy health care personnels involved in care during COVID 19 pandemic 
 
ExclusionCriteria 
Details  1. Pregnancy
2. Immunocompromised
3. Patients suffering from any chronic illness e.g. Heart, Lung, Liver, Kidney ailments and any chronic systemic disease.
4.Musculoskeletal disease
5. Individuals with acute Illness within past 01 month which is not evaluated. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Psychological measures: anxiety (GAD 7), positive and negative affect (PANAS) and trait of worry (PSWQ).

Self-efficacy

Team efficacy : Confidence about being able to handle the COVID-19 crisis as a team (through questionnaire)

Health: General health, Mental health and Vitality

Job Satisfaction

Physiological measures : Heart rate variability(time and Frequency domain) and Baroreflex sensitivity  		 03 months 
 
Secondary Outcome  
Outcome  TimePoints 
Knowledge and attitude (wilingness to serve) towards COVID-19 (through questionnaire)  03 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   08/07/2020 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   We are planning to study - The role of Yoga in de stressing health care personnel during COVID 19 pandemic-A Randomised control trial from a tertiary care centre in North India. Actually COVID-19 has created an unprecedented situation to mankind and has challenged the limits of health care system; more so health care providers are stretched to their limits physically as well as psychologically. We are putting an effort to assess stress levels in Health care providers during the current COVID-19 pandemic and trying to establish role of Yoga in improving immunity, thus helping health care workers who are already in much stress from risk of contracting infectious disease, COVID 19. This is a randomised controlled study with a passive control arm. The experimental group would be periodically given guided Yoga-based intervention, and support material for daily self-practice. The guided sessions would be conducted in online mode. Pre and post measurements of psychological parameters such as stress, anxiety, depression and physiological parameters such as blood pressure variability and heart rate variability will be taken for both the groups to perform a comparative assessment. 
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