| CTRI Number |
CTRI/2025/03/082374 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| 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 Nadamaya Meditation on Attention in Healthy University Students |
|
Scientific Title of Study
|
Neurophysiological signatures of Nadamaya meditation and its impact on attention among healthy university volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Patra |
| Designation |
Professor |
| Affiliation |
central University of Rajasthan |
| Address |
Department of Yoga, Neurophysiology lab, Room no. 5, Central University of Rajasthan, Ajmer, Pin- 305817, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
8618142265 |
| Fax |
|
| Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Megha Pundir |
| Designation |
PhD Scholar |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Neurophysiology lab, Room no. 5, Central University of Rajasthan, Ajmer, Pin- 305817, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
8218172780 |
| Fax |
|
| Email |
meghapundeer20899@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Pundir |
| Designation |
PhD Scholar |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Neurophysiology lab, Room no. 5, Central University of Rajasthan, Ajmer, Pin- 305817, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
8218172780 |
| Fax |
|
| Email |
meghapundeer20899@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central University of Rajasthan, Ajmer, Rajasthan, Pin- 305817, India |
|
|
Primary Sponsor
|
| Name |
Central University of Rajasthan |
| Address |
Central University of Rajasthan, Ajmer, Pin-305817, Rajasthan, India |
| Type of Sponsor |
Other [Central University of Rajasthan, a Central government 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 Sanjib Patra |
Central University of Rajasthan |
Department of Yoga, Neurophysiology lab, Lab no.- 05
Ajmer
RAJASTHAN |
8618142265
sanjib.patra@curaj.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of the Central University of Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers, University Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Classical Music |
Participants will be listening to a 26 minutes of Classical music |
| Intervention |
Meditation |
26 minutes Meditation, focused on listening to the sound of OM |
| Comparator Agent |
Mind wandering |
Participants will be sitting for 26 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
The healthy university students with no prior experiences of yoga or meditation in last one year will be included in this study. |
|
| ExclusionCriteria |
| Details |
The student diagnosed with any physical/mental illness or ongoing medication will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physiological Parameters:
EEG (Electroencephalography): To measure brain activity.
Respiration Rate: To monitor breathing patterns.
PPG (Photoplethysmography): To assess heart rate and blood flow.
GSR (Galvanic Skin Response): To measure skin conductance as an indicator of arousal.
ECG (Electrocardiography): To record the electrical activity of the heart.
Attention Assessment:
Auditory Oddball Task: Conducted twice, once before and once after the intervention, to measure immediate changes in attention. |
2 (Pre and Post) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mindful Attention Awareness Scale (MASS)
Depression, Anxiety, and Stress Scale (DASS 21)
Positive and Negative Affect Schedule (PANAS)
Multidimensional Assessment of Interoceptive Awareness (MAIA 2)
Exteroceptive Body Awareness Questionnaire (EBA-q)
Depth of Meditation Questionnaire |
2 (Pre and Post) |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
26/03/2025 |
| 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="0"
Months="3"
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
|
This study will investigate the immediate and long-term
effects of meditation on attention among healthy university
students and compare the changes in physiological
parameters (EEG, respiration, PPG, GSR, and ECG) during meditation, classical music listening, also mind wandering. This study will also assess the immediate impact of meditation, classical music listening, and mind wandering on attention
using the auditory oddball task.
|