| CTRI Number |
CTRI/2020/09/028086 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of 12-weeks of Online Sudarshan Kriya Yoga practice on Burnout and Health Parameters among COVID-19 Frontline Warriors. |
|
Scientific Title of Study
|
Efficacy of Sudarshan Kriya Yoga (SKY) based 12 weeks’ Online Breath and Meditation Workshop on change in Burnout and Ballistocardiography (BCG) assessments among Medical Professionals at a Tertiary Care Hospital during COVID-19 Pandemic: A Single Arm 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 Monika Pathania |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Dept. of General Medicine, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Pathania |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Dept. of General Medicine, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Pathania |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Dept. of General Medicine, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA MARG, PASHULOK, RISHIKESH, UTTARAKHAND - 249203. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika Pathania |
All India Institute of Medical Sciences Rishikesh |
Office-1, Dept. of General Medicine, Level-5, Medical College Block-A, AIIMS Rishikesh
Dehradun
UTTARANCHAL |
8126021556
anshupathania27@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable (single Arm Trial) |
Not Applicable |
| Intervention |
Sudarshan Kriya Yoga (SKY) based 12 weeks’ Online Breath and Meditation Workshop |
The 12-week long intervention will be having 3 main components:
1. Online 4-day Sudarshan Kriya Yoga (SKY) based Breath and Meditation Workshop for initiation to SKY practice
2. Daily SKY practice at home using mobile application for 12 weeks
3. Weekly follow-up sessions for 12 weeks
The initial online Sudarshan Kriya Yoga (SKY) based Breath and Meditation Workshop will be led by an Art of Living Teacher/Instructor. It will last for 4 days with 2 hours spent per day and will consist of interactive sessions, knowledge sharing, and initiation to SKY with practical demonstration along with home going instructions for daily practice at home. Daily home SKY practice session will be of 30 minutes each and will be led by PI/Co-PI/research-staff using a smartphone app installed on the participant’s device. In the weekly long SKY follow up sessions, participants will undergo group SKY sessions of longer duration than daily practice and will get an opportunity to express their views regarding the practice and provide feedback about the course and experiences felt during the practice. During each weekly follow up session, regular practice of SKY will be reinforced and participant’s compliance to daily practice will be checked. Any doubts regarding the practice of SKY and/or using the mobile app will also be clarified during weekly sessions. Intervention will be provided in groups of 5 participants at a time. A minimum of 75% adherence to the intervention will be required from the participants to qualify for final assessment. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Medical Professionals working at AIIMS Rishikesh for at least 6 months
Within age group of 18 to 65 years
Willing to commit to at least 75% of total intervention period
Having a smartphone device to avail online intervention along with at home practice sessions
|
|
| ExclusionCriteria |
| Details |
Already practicing yoga/meditation/stress reduction technique for more than 1 month in the previous 6 months
Unable to practice yoga due to: musculoskeletal disorders, severe cervical pain, severe back pain or arthritis
Having medical conditions like epilepsy, migraine, or any psychiatric disorder
Pregnant women
Not willing to provide a written informed consent
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Burnout Scores (using 22-item Maslach Burnout Inventory Human Services Survey for Medical Personnel) [MBI-HSS (MP)] |
Baseline (after participant enrollment)
Endpoint (after 12 weeks of intervention) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Blood Pressure (mm of hg)
Resting Heart rate/Pulse Rate (Beats per Minute/BPM)
Heart Rate Variability (SDNN, RMSSD, LF/HF)
Respiration Rate (Breaths per Minute)
Sleep Duration and Stages (Light, Deep, Wake, Rapid Eye Movement/REM) |
Baseline (after participant enrollment)
Endpoint (after 12 weeks of intervention) |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
08/10/2020 |
| 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="6"
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)?
Response - NO
|
|
Brief Summary
|
Project Title: Efficacy of Sudarshan Kriya Yoga (SKY) based 12 Weeks’ online Breath and Meditation Workshop on Change in Burnout and Ballistocardiography (BCG) assessments among Medical Professionals at a Tertiary Care Hospital during COVID-19 Pandemic: A single arm trial. Introduction: Burnout is a common occupational phenomenon among medical care providers, worldwide. People experiencing burnout show outcomes similar to those reporting substantial job strain or vital exhaustion. Studies suggest that elongated periods of stress lead to dysregulation of sympathetic-adrenal-medullary (SAM) system and adaptational failure of hypothalamic pituitary adrenal (HPA) axis to reactivity and recovery during and after stress inducing tasks. It is this stress related deregulation of the sympathetic and parasympathetic system along with the HPA axis that causes elevated heart rate, hypertension, dysregulated Heart Rate Variability Irregular and disturbed sleep, making Burnout as an important risk factor for cardiovascular disease. Chances of physician burnout during epidemic viral outbreaks may increase drastically due to continuous patient inflow and due to stress created by the fear of getting infected from the highly contagious disease. Ballistocardiography (BCG) is an Artificial Intelligence (AI) powered technology which has been recently innovated and validated (with 98.4% medical grade accuracy) for assessing an individual’s Resting Heart rate/Pulse Rate, Heart Rate Variability, Respiration Rate, Sleep Duration and Stages. Very little research work has been conducted on burnout among medical professionals in India, and almost none in regard to use of yogic interventions for relieving/alleviating it. Sudarshan Kriya Yoga (SKY) has been shown to improve health, vitality, well-being, and peace of mind while reducing stress and anxiety, yet no intervention studies have been conducted in India assessing SKY’s effect on professional burnout in medical professionals, to the best of our knowledge. Aim: This study may help assess the efficacy of Sudarshan Kriya Yoga for 12-weeks using an online breath and meditation workshop on change in levels of Burnout and Ballistocardiography (BCG) assessments among medical professionals at a tertiary care hospital during the Corona Virus Crisis. Objectives: 1.To determine efficacy of 12-week long Sudarshan Kriya Yoga (SKY) based online breath and meditation workshop on change in Levels of Burnout on three dimensions: Emotional Exhaustion, Depersonalization & Personal Accomplishment 2.To determine efficacy of 12-week long Sudarshan Kriya Yoga (SKY) based online breath and meditation workshop on change in Ballistocardiography (BCG) assessments of the following health parameters: Cardiopulmonary parameters: Blood Pressure, Resting Heart Rate and Respiration Rate; Sleep parameters: Duration and Stages (Light, Deep, Wake, REM); Heart Rate Variability (SDNN, RMSSD, LF/HF) as a parameter of Stress. |