| CTRI Number |
CTRI/2026/01/101110 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Yoga Nidra for Improving Mental Health and Well-Being of Students |
|
Scientific Title of Study
|
Comparative Effectiveness of Yoga Nidra Variants for Student
Flourishing: A Three-Arm Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Garg |
| Designation |
Professor |
| Affiliation |
Department of Computer Science and Engineering, Indian Institute of Technology |
| Address |
Block-V Room No. 401, Indian Institute of Technology Room number 104, Department of Computer Science and Engineering, Block IIA,Bharti Building, Indian Institute of Technology New Delhi DELHI 110016 India |
| Phone |
1126596595 |
| Fax |
|
| Email |
rahulgarg@cse.iitd.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Vicky Kachera |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Resource Centre for Value Education in Engineering, Indian Institute of Technology |
| Address |
Block-V Room No. 401, Indian Institute of Technology
New Delhi DELHI 110016 India |
| Phone |
8824447596 |
| Fax |
|
| Email |
nrz238177@nrcvee.iitd.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Rahul Garg |
| Designation |
Professor |
| Affiliation |
Department of Computer Science and Engineering, Indian Institute of Technology |
| Address |
Block-V Room No. 401, Indian Institute of Technology Room number 104, Department of Computer Science and Engineering, Block IIA,Bharti Building, Indian Institute of Technology New Delhi DELHI 110016 India |
| Phone |
1126596595 |
| Fax |
|
| Email |
rahulgarg@cse.iitd.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Technology, Delhi Hauz Khas, New Delhi-110016
|
|
|
Primary Sponsor
|
| Name |
Indian Institute of Technology |
| Address |
Block-V Room No. 401, Indian Institute of Technology, Delhi Hauz Khas, New Delhi-110016
|
| Type of Sponsor |
Other [Indian Institute of Technology ] |
|
|
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 |
| Vicky kachera |
NRCVEE - National Resource Centre for Value Education in Engineering |
Block-V Room No. 401,NRCVEE - National Resource Centre for Value Education in Engineering, Indian Institute of Technology, Delhi Hauz Khas, New Delhi-110016
New Delhi DELHI |
8824447596
nrz238177@nrcvee.iitd.ac.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 |
Healthy students (self reported) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator |
No Intervention Control |
| Intervention |
Integrated Yogic Relaxation Module Variant A |
Integrated Yogic Relaxation Module consisting of Sukshma Vyayama, Pranayama, brief high intensity yogic practices, and a concluding Yoga Nidra session. Sessions will be conducted two times per week for approximately fourteen weeks. Each session will last sixty minutes and will be supplemented with Yoga based wellness education. |
| Intervention |
Integrated Yogic Relaxation Module Variant B |
Integrated Yogic Relaxation Module consisting of Sukshma Vyayama, Pranayama, brief high intensity yogic practices, and a concluding Yoga Nidra session, with variations in specific practices and structure compared to Variant A. Sessions will be conducted two times per week for approximately fourteen weeks. Each session will last sixty minutes and will be supplemented with Yoga based wellness education. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 and 35 years.
2. Willingness to provide informed consent.
3. Basic knowledge of the English language.
4. No history of severe psychiatric or medical conditions (self-reported). |
|
| ExclusionCriteria |
| Details |
1. Suffering from clinical mental health disorder or taking medication for the same
(self-reported). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety (GAD-7 score) |
Baseline and at 14 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Perceived stress
Sleep quality
Depressive symptoms
Flourishing
Peace of mind
Satisfaction with life
Positive affect
Negative affect
Cognitive performance
Prakriti
Vikriti
Manas Prakriti |
Baseline and at 14 weeks |
|
|
Target Sample Size
|
Total Sample Size="630" Sample Size from India="630"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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="3" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vickyk.iitdelhi@gmail.com].
- For how long will this data be available start date provided 01-12-2026 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of Integrated Yogic Relaxation Modules, including Yoga Nidra, in reducing anxiety and improving overall mental well-being among university students. Yoga Nidra is a guided mind–body relaxation technique that has shown potential benefits for stress reduction, emotional regulation, and psychological well-being; however, existing research is limited by small sample sizes and a lack of systematic, controlled designs. The study will be conducted among students of IIT Delhi using a three-arm, longitudinal design implemented over three consecutive academic semesters. In each semester, 210 participants will be enrolled and allocated into three groups. Two intervention groups will receive different versions of an Integrated Yogic Relaxation Module comprising Sukshma Vyayama, Pranayama, brief high-intensity yogic practices, and a concluding Yoga Nidra session, along with Yoga-based wellness education. Sessions will be conducted twice weekly for approximately 14 weeks. A third group will serve as a no-intervention control and will continue their usual daily routines. Across the three semesters, a total of 630 participants will be enrolled. Psychological outcomes including anxiety, stress, sleep quality, depressive symptoms, well-being, life satisfaction, peace of mind, affect, and cognitive performance will be assessed at baseline and post-intervention using validated psychometric scales and smartphone-based cognitive tasks. Ayurvedic constitutional factors (Prakriti, Vikriti, and Manas Prakriti) will also be explored as potential moderators of intervention effects. The findings of this programmatic research are expected to inform the systematic refinement of Integrated Yogic Relaxation Modules and to identify effective, scalable Yoga-based interventions to support student mental health and well-being in a university setting. |