| CTRI Number |
CTRI/2021/01/030752 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| 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 Online Yoga for 12-weeks in comparison to no-treatment on change in Burnout and Professional Quality of Life among COVID-19 Frontline Warriors. |
|
Scientific Title of Study
|
Efficacy of mHealth aided 12-week Rhythmic-Yoga-
Breathing Intervention on change in Burnout and Professional Quality of Life among Health Care Providers at a Tertiary Care Hospital during COVID-19 pandemic: A Randomized Waitlist-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 Monika Pathania |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Associate Professor, Dept. of General Medicine, Level-6, Medical College Block-A, All India Institute of Medical Sciences, Near Barrage, Pashulok, Rishikesh - 249203.
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 |
Associate Professor, Dept. of General Medicine, Level-6, Medical College Block-A, All India Institute of Medical Sciences, Near Barrage, Pashulok, Rishikesh - 249203.
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 |
Associate Professor, Dept. of General Medicine, Level-6, Medical College Block-A, All India Institute of Medical Sciences, Near Barrage, Pashulok, Rishikesh - 249203.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director, All India Institute of Medical Sciences, Rishikesh |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology DST SATYAM Science And Technology of Yoga And Meditationy |
| Address |
Technology Bhavan,
New Mehrauli Road,
New Delhi - 110016.
KIRAN Division,
Department of Science & Technology, Ministry of Science & Technology, Government of India. |
| Type of Sponsor |
Government funding agency |
|
|
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 Monika Pathania |
All India Institute of Medical Sciences Rishikesh |
Dept. of General Medicine, Level-6, Medical College Block-A, All India Institute of Medical Sciences, Near Barrage, Pashulok, Rishikesh - 249203.
Dehradun
UTTARANCHAL |
8126021556
anshupathania27@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mHealth aided rhythmic-yoga-breathing intervention for 12-weeks |
The 12-weeks long mHealth aided rhythmic-yoga-breathing intervention will have 3 main Components:
1. Online 4-day orientation program: The initial 4-day orientation program will be led online by research staff cum yoga Instructor using a Smartphone based video conferencing app, with 2 hours spent per day, consisting of interactive sessions, knowledge sharing, and initiation to the rhythmic-yoga-breathing with practical demonstration along with home going instructions for daily home practice on the last day.
2. Daily short rhythmic-yogic-breathing practice at home: Daily home practice session will last 30-40 minutes each and will be assisted by a mobile app installed on the participant’s Smartphone device. Compliance to daily practice will also be checked using the daily practice log provided in the same app.
3. Weekly online follow-up sessions: In the weekly follow up sessions, participants will undergo group sessions of rhythmic-yoga-breathing with longer duration than daily practice and will get an opportunity to express their views and provide feedback about the course and experiences felt during the practice. During each weekly follow up session, the yoga Instructor will reinforce regular practice of rhythmic-yoga-breathing and also check participant’s compliance to daily practice along with clarifying any doubts regarding the practice or using the mobile application.
A minimum of 75% adherence to the Rhythmic-Yoga-Breathing intervention will be required from the participants to qualify for final assessment. |
| Comparator Agent |
Wait-List Control |
No specific Intervention will be given to control arm. Participants in this arm will be asked to continue with their daily routine as such, and to wait for 12 weeks. All control arm participants will be initiated to the Rhythmic-Yoga-Breathing Intervention immediately after completion of 12 weeks of waiting period; however, no outcome assessments will be made from this point onward. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Health care providers at AIIMS Rishikesh (working for at least 6 months)
2. Within age group of 18 to 65 years
3. Willing to commit to at least 75% of total intervention period
4. Having a Smartphone device to avail mHealth aided intervention and home practice sessions
5. Willing to be wait-listed if allocated to the control arm. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Already practicing some form of yoga/meditation for more than 1 month in the previous 6 months
2. Unable to practice yoga due to: musculoskeletal disorders, severe cervical pain, severe back pain or arthritis
3. Having medical conditions like epilepsy, migraine, or any psychiatric disorder
4. Pregnant women
5. Not willing to provide a written informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Variables:
1. Maslach Burnout Inventory scores- evaluated on three dimensions:
a.Emotional Exhaustion
b.Depersonalisation
c.Personal Accomplishment
2. Professional Quality of Life (Pro QOL) scores- evaluated on two dimensions:
a.Compassion Satisfaction
b.Compassion Fatigue: Burnout & Secondary Traumatic Stress |
Baseline (after participant enrollment)
Endpoint (after 12 weeks of intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Blood Pressure
b. Resting Heart Rate
c. Anthropometric Measurements:
Weight
Height
Basal Metabolic Index
Waist Circumference
Hip Circumference
waist to Hip Ratio |
Baseline (after participant enrollment)
Endpoint (after 12 weeks of intervention) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/01/2021 |
| 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="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
|
Summary: Burnout is a common occupational phenomenon among health care providers. Chances of physician burnout increase during epidemic viral outbreaks due to continuous patient inflow and due to stress created by the fear of infection. There is a paucity of research work conducted on burnout among doctors and physicians in India, and almost none in regard to use of yogic interventions for relieving/alleviating it. Yogic Pranayama and rhythmic breathing techniques like Sudarshan Kriya have 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 to assess its effect on professional burnout, to the best of our knowledge. In this randomized waitlist-controlled trial, we propose to assess the efficacy of a 12-week long mHealth aided rhythmic-yoga-breathing intervention among health care providers of a tertiary care hospital. This study may prove beneficial for the participants, i.e. doctors, medical professionals and health care providers undergoing tremendous levels of stress, handling patients during the time of a global pandemic. It may also help assess the use of mHealth as a delivery system for yoga interventions, which is still an evolving concept with a lot of untapped potential but with very little research work done in India. This study may provide with sufficient evidence for efficacy of yoga concerning its use for professional burnout among physicians and health care providers and add to the armamentarium of tools for fighting stress, especially during this time of COVID-19 pandemic.
Aims: We aim to evaluate the efficacy of mHealth aided rhythmic-yoga-breathing intervention for 12 weeks’ on Burnout and Professional Quality of Life, among health care providers working at a tertiary care hospital during COVID-19 pandemic. In addition, we further want to compare the pre-post Intervention assessments of the experimental and waitlist-control arms.
Primary Objectives: - To determine efficacy of rhythmic-yoga-breathing intervention on Burnout.
- To determine efficacy of rhythmic-yogic-breathing intervention on Professional Quality of Life.
- To compare changes in Burnout and Professional Quality of Life among participants in experimental and waitlist-control arms.
Secondary Objectives: a. To assess changes occurring before and after 12 weeks of rhythmic-yoga-breathing intervention in: - Blood Pressure
- Resting Heart Rate
- Anthropometric measurements (Weight, Height, BMI, Waist Circumference, Hip Circumference, Waist to Hip Ratio)
b. To compare change in above parameters among participants in experimental and waitlist-control arms before and after rhythmic-yoga-breathing intervention. |