| CTRI Number |
CTRI/2025/07/090793 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of technology-assisted Yoga for Young Adults with Stress |
|
Scientific Title of Study
|
Impact of Virtual Reality-Based Mindfulness on Young Adults: A Pilot 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 |
Ms Shravika S Shetty |
| Designation |
MSc Yoga Student |
| Affiliation |
Manipal Academy of Higher Education Manipal |
| Address |
Div. of Yoga, CIMR, MAHE, Manipal
Opp to Artificial Limb Centre
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8904691372 |
| Fax |
|
| Email |
shravika.doympl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetinakumar Patil |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education Manipal |
| Address |
Div. of Yoga, CIMR, MAHE, Manipal
Opp to Artificial Limb Centre
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetinakumar Patil |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education Manipal |
| Address |
Div. of Yoga, CIMR, MAHE, Manipal
Opp to Artificial Limb Centre
Udupi
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Karnataka, India , Pin-576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Division of Yoga CIMR, MAHE Manipal, India - 576104
|
| Type of Sponsor |
Other [Deemed to be University] |
|
|
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 Neetinkumar Patil |
Division of Yoga |
Room No 4, 1st Floor, Dormitory building
(Opp. Artificial Limb Center) Division of
Yoga Centre for Integrative Medicine and
Research, Manipal, India [CIMR] Udupi
Udupi
KARNATAKA |
9886211008
ayushnitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Audio bassed Mindfullness |
Audio-based Mindfullness for 10 minutes, 5 days per week for 1 month |
| Intervention |
Virtual Reality (VR) based Meditation |
Virtual Reality (VR) based Meditation for 10 minutes per session, for 5 days for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Young adults between the ages of 18 and 30.
2.Perceived Stress Scale score 14 to 26 (moderate stress)
3.Fluent in English for instructions |
|
| ExclusionCriteria |
| Details |
1.Severe mental health conditions (e.g., PTSD, major depression).
2.Photophobia or light sensitivity causing discomfort in VR.
3.Neurological issues (e.g., epilepsy, vertigo, severe migraines).
4.Severe physical impairments limiting VR use.
5.Use of psychotropic medication that may influence results.
6.Prior experience with VR-based mindfulness and yoga practice in last 3 month |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceived Stress Scale (PSS)
Heart Rate Variability (HRV)
Electroencephalography (EEG)
Simulator Sickness Questionnaire (SSQ) |
Immidiate Effect - after Single session (Pre-Post)
Short term effect - Baseline and after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHOQOL-BREF (Quality of Life) |
Short-term effect - Baseline and after 1 month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Young adults face rising stress, anxiety, and distractions in today’s fast-paced digital world. Traditional mindfulness practices are effective but may not engage this tech-savvy generation. Virtual Reality (VR) offers an immersive and interactive platform to deliver mindfulness in a more appealing way. This pilot study explores the potential of VR-based mindfulness to improve focus, emotional well-being, and stress management among young adults, paving the way for innovative mental health interventions. |