| CTRI Number |
CTRI/2025/05/087291 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of yoga among nursing students |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of Common Yoga Protocol (CYP) on selected physiological and psychological outcome variables among nursing students, NINE, PGIMER, Chandigarh, 2024-26.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anju Antony |
| Designation |
Nursing Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh.. My college |
| Address |
NINE, PGIMER, Chandigarh, India -160012
Chandigarh
CHANDIGARH
140901
India |
| Phone |
8727960780 |
| Fax |
|
| Email |
anjuantony33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anju Antony |
| Designation |
Nursing Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh.. My college |
| Address |
NINE, PGIMER, Chandigarh, India -160012
Chandigarh
CHANDIGARH
140901
India |
| Phone |
8727960780 |
| Fax |
|
| Email |
anjuantony33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSukhpal Kaur |
| Designation |
Principal , NINE,PGIMER,Chandigarh |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh.. My college |
| Address |
Office of The Principal, NINE, PGIMER, Chandigarh, India -160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888536964 |
| Fax |
|
| Email |
sukhpal.trehan@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anju Antony |
| Address |
NINE,PGIMER,Chandigarh |
| Type of Sponsor |
Other [] |
|
|
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 Sukhpal Kaur |
NINE Hostel |
Open Theater, NINE Hostel, NINE, PGIMER, Chandigarh, India -160012
Chandigarh
CHANDIGARH |
9888536964
sukhpal.trehan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER,Chandigarh,Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Those who are meeting the inclusion criteria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMMON YOGA PROTOCOL |
Standard treatment |
| Intervention |
Common Yoga Protocol(CYP) |
The Common Yoga Protocol is a 45-minute standardized yoga routine developed by the Ministry of AYUSH. It includes:
Prayer – Opening chant (1–2 min)
Loosening Exercises – Warm-up movements (5 min)
Asanas – Postures for strength and flexibility (20 min)
Pranayama – Breathing techniques (10 min)
Dhyana – Meditation for mental calm (5 min)
Closing – Sankalpa and Shanti Patha (2–3 min)
For 8 weeks,45 minute session,5 days per week under supervision of a yoga practitioner |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Nursing students residing in the NINE, PGIMER, Chandigarh hostel who are willing to participate in the yoga intervention. |
|
| ExclusionCriteria |
| Details |
1. Students who are regularly practicing yoga
2. Students with musculoskeletal or balance issues that prevent physical activity or participation in the study.
3. Students who are under treatment with psychotropic and steroid drugs.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of yoga on Perceived Stress Levels
|
1. Baseline assessment
2. After 8-week intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall wellbeing gained with yoga practice |
after the intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/07/2025 |
| 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 Yet Recruiting |
| 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
|
This is an interventional study with Yoga as the intervention. Out of the total 100 participants, 50 will be in the intervention group and 50 will be in the control group. For a period of 8 weeks, the intervention group will practice Yoga. An initial assessment will be conducted after the recruitment and the second assessment will be after the 8-week Yoga intervention. The commencement of the planned study will be in the first week of July 2025. |