| CTRI Number |
CTRI/2025/02/081451 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Preksha Dhyana on Young Adults |
|
Scientific Title of Study
|
Comparative study on the effectiveness of traditional and virtual reality-based
Preksha Dhyana on Generation Z |
| 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 Manoj Ghosh |
| Designation |
PhD Scolar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Division of Yoga, Centre for Integrative Medicine and Research [CIMR-Yoga], Manipal Academy of Higher Education, Manipal, [MAHE]
Udupi
KARNATAKA
576104
India |
| Phone |
7908480348 |
| Fax |
|
| Email |
mg.prahlad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEETINAKUMAR PATIL |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Division of Yoga, Centre for Integrative Medicine and Research [CIMR-Yoga], Manipal Academy of Higher Education, Manipal, [MAHE]
Udupi
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEETINAKUMAR PATIL |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Division of Yoga, Centre for Integrative Medicine and Research [CIMR-Yoga], Manipal Academy of Higher Education, Manipal, [MAHE]
Udupi
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar Manipal, Karnataka, India- 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Division of Yoga, Centre for Integrative Medicine and Research [CIMR-Yoga], Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India - 576104 |
| Type of Sponsor |
Other [Deemed to be University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| UGC New Delhi |
UGC , New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetinakumar Patil |
Kasturba Hospital |
Room No1, 1st Floor, Dormitory building (Opp. Artificial Limb Center) Division of Yoga Centre for Integrative Medicine and Research, Manipal, India [CIMR]
Udupi
KARNATAKA
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 |
Perceived Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Traditional Preksha Dhyana (Meditation) |
Kayotsarga
Shwasapreksha
Antaryatra
Jyothikendra Preksha
for 15 minutes each session
5 days a week for 1 month |
| Intervention |
Virual Reality based Preksha Dhyana (Meditation) |
Kayotsarga
Shwasapreksha
Antaryatra
Jyothikendra Preksha
for 15 minutes each session
5 days a week for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Both |
| Details |
Adult Generation Z that is people who born between 1997 to 2012
|
|
| ExclusionCriteria |
| Details |
Mindfulness-based practice in the last 3 months.
Participants with a history of neurological or psychiatric conditions, or those on
medication that could affect relaxation or cognitive processes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive and Affective Mindfulness ScaleRevised
Perceived Stress Scale
Cancellation Test
PANAS
WHOQOL-BREF
EEG
HRV
|
0 Day
1 Month
3 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Close- and open-ended questions for user
experience with SSQ |
0 Day
1 Month
3 Months |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
18/03/2025 |
| 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="2"
Months="0"
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
|
With increasing stress and digital engagement among Generation Z, there is a growing need for effective meditation techniques to enhance mental well-being. Traditional meditation practices like Preksha Dhyana have proven benefits, but their adoption is declining among younger generations. Virtual Reality (VR)-based meditation offers an immersive alternative that may enhance engagement and effectiveness. However, there is limited research comparing traditional and VR-based meditation methods. This study aims to evaluate and compare their impact on stress reduction, focus, and emotional well-being in Generation Z, providing insights into the most effective approach for modern mindfulness practices. |