| CTRI Number |
CTRI/2025/03/081779 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ten minutes Yoga at workplace among employees of a tertiary care hospital for stress management. |
|
Scientific Title of Study
|
Effect of Ten Minutes Yoga at the Workplace on Perceived Stress and Work Engagement among Employees of a Tertiary Care Hospital: A Pilot and Feasibility Study. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh Kumar Sahu |
| Designation |
Yoga Instructor |
| Affiliation |
Department of AYUSH |
| Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9777113932 |
| Fax |
|
| Email |
yoga_santosh@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Kumar Sahu |
| Designation |
Yoga Instructor |
| Affiliation |
Department of AYUSH |
| Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9777113932 |
| Fax |
|
| Email |
yoga_santosh@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Kumar Sahu |
| Designation |
Yoga Instructor |
| Affiliation |
Department of AYUSH |
| Address |
All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9777113932 |
| Fax |
|
| Email |
yoga_santosh@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bhubaneswar, |
| Address |
Sijua, Patrapada, Bhubaneswar, Khordha, Odisha - 751019 |
| 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 Ajit Kumar Pradhan |
All India Institute Of Medical Sciences |
Room No-03, Department of AYUSH, Sijua, Patrapada, Bhubaneswar - 751019
Khordha
ORISSA |
9337832305
ayush_ajit@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
He/she must be an employee of All India Institute of Medical Sciences, Bhubaneswar |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
This is a single group study, hence no requirement of comparator. |
| Intervention |
Yogasana and Pranayama |
Ten minutes yoga practices at work place |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
An individual must be an employee of All India Institute of Medical Sciences, Bhubaneswar, and willing to participate in this study. |
|
| ExclusionCriteria |
| Details |
A person who has undergone recent surgical intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A - Feasibility will be assessed through recruitment, eligibility, willingness to participate, questionnaire response, and intervention adherence.
B - Change in Perceived stress score from baseline.
C - Change in work engagement score from baseline. |
After 12 weeks of yoga practice |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality-of-life score and sleep quality from baseline and after 12 weeks of yoga practice. |
After 12 weeks of yoga practice |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The current study will be a pilot and
feasibility study to evaluate the feasibility and effectiveness of ten minutes
of yoga at the workplace on perceived stress and work engagement of employees
of All India Institute of Medical Sciences, Bhubaneswar. We will evaluate
perceived stress by Perceived stress scale questionnaire, work engagement by Utrecht’s
work engagement scale questionnaire as primary outcome and measure the quality
of life by WHO Quality of Life (WHOQOL-BREF) scale, sleep quality by Pittsburgh
Sleep Quality Index (PSQI) as the secondary outcome after 12 week of yoga
intervention. The study will be conducted by Dept. of AYUSH, AIIMS Bhubaneswar.
The sample size will be 70 and it is a single group pre-post design, pilot, and
feasibility study which is expected to be completed within one year. |