| CTRI Number |
CTRI/2024/07/070442 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga modules for burnout among healthcare workers |
|
Scientific Title of Study
|
Efficacy of yoga modules for reducing burnout amongst people working in stressful situations in the tertiary care hospital of Uttarakhand A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vartika Saxena |
| Designation |
Professor & HOD, Department of CFM, AIIMS Rishikesh |
| Affiliation |
Department of community and family medicine, AIIMS Rishikesh |
| Address |
Level 5, Department of Community and Family Medicine, Medical College building, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
vartika.cfm@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikas Upadhyay |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
Level 5, Department of Community and Family Medicine, Medical College Building, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9716277264 |
| Fax |
|
| Email |
vkupadh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikas Upadhyay |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
Level 5, Department of Community and Family Medicine, Medical College Building, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9716277264 |
| Fax |
|
| Email |
vkupadh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Science Research Board, DRDO, Delhi-110054, India |
|
|
Primary Sponsor
|
| Name |
Life Science Research Board, DRDO |
| Address |
Ministry of Defence, Defence Research and Development Organisation Headquarters, LSRB, Room no. 409, 4th floor, DRDO Hqrs, Delhi-110054 |
| 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 Vartika Saxena |
AIIMS Rishikesh |
Room no. 015106, Department of Community and Family Medicine, AIIMS Rishikesh, Veerbhadra Road, Pincode-249203
Dehradun
UTTARANCHAL |
9997454915
vartika.cfm@aiimsrishikesh.edu.in |
|
|
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 |
Burnout |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
20-min yoga module / 30-minute Dipas yoga module |
20-min yoga module for duration of 4-weeks and atleast 4 days in a week
30-minute yoga module for a duration of 4-weeks and atleast 4 days in a week |
| Comparator Agent |
20-minute medium pace walking and 30-minute medium pace walking |
For study 1: 20-minute medium pace walking with 2.5 miles per hour to 3.5 miles per hour (1300-1800 meter in 20 minute) in a day for a duration of 4-weeks, will be provided as an intervention for reducing burnout among participants of this group.
For study 2: 30-minute medium pace walking with 2.5 miles per hour to 3.5 miles per hour (1800-2300 meter in 30 minute) in a day for a duration of 4-weeks, will be provided as an intervention for reducing burnout among participants of this group. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Study participants will be healthcare workers of AIIMS, Rishikesh |
|
| ExclusionCriteria |
| Details |
Participants having any of the following condition will be excluded:
1. drug addiction/substance abuse
2. any psychiatric disorder
3. other medical illness refraining practice of yoga modules
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of yoga modules for reduction in burnout and chronic stress among healthcare workers |
Burnout and chronic stress will be assessed at baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of yoga modules among healthcare workers for:
1. Improvement in HRV
2. Immediate reduction in state anxiety
3. Improvement in selective attention
4. Increase in happiness
|
HRV & Happiness will be assessed at baseline & after 4 weeks of intervention. State anxiety & selective attention will be assessed immediately before & after intervention on day 1, 14 & 28 |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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)
|
22/07/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 chronic workplace distress. In the recent COVID-19 pandemic era, high burnout can be found among people involved directly or indirectly in the management of the pandemic situation, such as healthcare workers. Yoga is a technique that improves mental and physical levels through posture, breathing control methods, and silencing the mind through meditation. Scientific breathing techniques and meditative practices administered together seem to effectively reduce burnout and anxiety in healthcare workers, providing them with consciousness and the ability to work in stressful conditions. Hence, the aim of this study will assess the efficacy of the yoga modules in reducing burnout among healthcare workers. |