| CTRI Number |
CTRI/2024/07/070612 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Short time Yoga break for Industrial workers |
|
Scientific Title of Study
|
Effect of Yoga-break at workplace on Stress, Sleep Quality and Quality of Life among the industrial workers in Faridabad, Haryana |
| 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 PUNEET MISRA |
| Designation |
PROFESSOR |
| Affiliation |
ALL INIDIA INSTITUTE OF MEDICAL SCIENCES, DELHI |
| Address |
Room No. 30, Centre for Community Medicine, Old OT Block, AIIMS New Delhi, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9868397372 |
| Fax |
|
| Email |
doctormisra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PUNEET MISRA |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 30, Centre for Community Medicine, Old OT BLock, Ansari Nagar, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9868397372 |
| Fax |
|
| Email |
doctormisra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PUNEET MISRA |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 30, Centre for Community Medicine, Old OT BLock, Ansari Nagar, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9868397372 |
| Fax |
|
| Email |
doctormisra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Piyush Bharti |
All India Institute of Medical Sciences, New Delhi |
Centre for Community Medicine, Old OT BLock, Ground floor, Ansari Nagar, AIIMS New Delhi
South
DELHI |
8989123311
pbbetul@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post-graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals which are healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Waitlisted Control Group |
Waitlisted Control in which NO intervention will be given to half of the workers i.e 150 wokrers for 90 days |
| Intervention |
Yoga group |
Yoga intervention to half of the workers i.e. 150 workers for the period of 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
working for past 6 months and about to continue in the same industry
for next 6 months, |
|
| ExclusionCriteria |
| Details |
1. major surgery patients in the recent past,
2. severe cardiac illness currently,
3. arthritis disabling joint movements,
4.. traumatic injury disabling to perform yoga
movements
5. pregnant females
6. Any other illness limiting to perform yoga |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effect of “Yoga break at workplace†on –Stress among industrial
workers in Faridabad, Haryana within 12 weeks. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the effect of “Yoga break at workplace†on -Sleep-quality among
industrial workers within 12 weeks.
2. To determine the effect of “Yoga break at workplace†on -Quality of life among
industrial workers within 12 weeks. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "296"
Final Enrollment numbers achieved (India)="296" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
06/12/2024 |
| Date of First Enrollment (Global) |
30/07/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
I want to see the effect of Yoga break protocol which has been released by Ministry of AYUSH, GOI, on Industrial workers to check whether it helps in mental improvement of workers. The stress on industrial workers is reported to be around 20% . The stress has been a major causative factor for depression and Cardiovascular disease. Along with that industrial workers have been reported to have poor sleep quality which in toto leads to poor Quality of life. This trial will help us to establish whether this short timed yoga intervention will help to decrease stress , improve sleep quailty and indirectly quality of life in industrial workers. |