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CTRI Number  CTRI/2021/01/030568 [Registered on: 19/01/2021] Trial Registered Prospectively
Last Modified On: 18/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Yoga for reducing burnout among healthcare workers 
Scientific Title of Study   Efficacy of Yoga for reducing burnout among healthcare workers: A 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  Vikas Upadhyay 
Designation  PhD Scholar 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Wing 2, Department of Community and Family Medicine, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9716277264  
Fax    
Email  vkupadh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vartika Saxena 
Designation  PhD Guide 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Wing 2, Department of Community and Family Medicine, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9716277264  
Fax    
Email  vartika.cfm@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Vikas Upadhyay 
Designation  PhD Scholar 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Wing 2, Department of Community and Family Medicine, All India Institute of Medical Sciences, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9716277264  
Fax    
Email  vkupadh@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh 
 
Primary Sponsor  
Name  AIIMS RISHIKESH 
Address  AIIMS RISHIKESH, VEERBHARDRA ROAD, 249203, UTTARAKHAND 
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 
Vikas Upadhyay  AIIMS Rishikesh  Wing 2, Department of Community and Family Medicine, All India Institute of Medical Sciences, Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL 		 9716277264

vkupadh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z578||Occupational exposure to other risk factors,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Defined Yoga Module  4-week yoga module, 20 minutes in a day comprises loosening exercises, scientific breathing technique and meditative practices 
Comparator Agent  Medium pace walking  Control group will be given 20-min medium pace walking as an intervention for reducing burnout. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. healthcare worker age ranges from 20-35 years
2. willing to participate in the study for the next 4 weeks
 
 
ExclusionCriteria 
Details  1. respiratory ailments (Asthma, Severe cough and cold etc.)
2. history of substance abuse
3. psychiatric disorder (psychoses, substance abuse, dementia)
4. pregnant women
5. any other life-threatening medical illness
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Burnout by Maslach Burnout Inventory (MBI)  Baseline and at end of 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in stress by Salivary Cortisol  Baseline and at end of 4 weeks 
Reduction of State Anxiety by State trait anxiety inventory  Before after intervention 
Improvement in Mindfulness by Mindful Attention Awareness Scale  Baseline and at end of 4 weeks 
Improvement in Compassion Satisfaction and Reduction in Compassion Fatigue by Professional Quality of Life (ProQoL)
 		 Baseline and at end of 4 weeks 
Improvement in Selective Attention
and Increase in Happiness by self rated scale of Happiness
 		 Before and after intervention 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   01/03/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Burnout is a state of emotional, physical and mental exhaustion caused by prolonged exposure to stresses at work. Due to burnout workers have lost sight at their own personal health and well-being. Several studies have also found a high prevalence of burnout and depression among healthcare workers, with rates higher than those of age-similar individuals pursuing other professionals. Galen the Greek physician (130-200 AD) states that, “The physician will hardly be thought very careful of the health of his patients if he neglects his own”.

Yoga is a technique that brings an improvement on mental and physical level by means of posture, breathing control methods and silencing the mind through meditation. Scientific breathing techniques and meditative practices administered together seem to be effective to reduce burnout and anxiety in healthcare workers, providing them with consciousness and ability to work in stressful conditions.

After the hectic duty hours of healthcare workers, a short duration yoga module is required that can be easily practiced by every professional. Therefore in this study we aim to check the efficacy of 20 min yoga comprising ANYB and meditative practices for reducing burnout among healthcare workers.

 
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