| CTRI Number |
CTRI/2025/07/091630 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| 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 Heartfulness and Bell Meditation on Brain Function among University Students |
|
Scientific Title of Study
|
Effect of Heartfulness and Bell Meditation on Brain Function among University Students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushil Prasad Mahato |
| Designation |
SENIOR RESEARCH FELLOW |
| Affiliation |
CENTRAL UNIVERSITY OF KERALA |
| Address |
Department of Yoga Studies, School of Medicine and Public Health, Central University of Kerala, Tejaswini Hills, CUK Campus Po, Kasaragod Dist, Kerala Central University of Kerala Kasaragod KERALA 671325 India |
| Phone |
9475453485 |
| Fax |
|
| Email |
sushilprasadmahato.2302207001@cukerala.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. M.Anjaladevi |
| Designation |
Assistant Professor |
| Affiliation |
CENTRAL UNIVERSITY OF KERALA |
| Address |
Department of Yoga Studies, School of Medicine and Public Health, Central University of Kerala. Tajaswini Hills, CUK Campus PO, Kasaragod Dist Kasaragod KERALA 671325 India |
| Phone |
9475453485 |
| Fax |
|
| Email |
anjaladevi.m@cukerala.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sushil Prasad Mahato |
| Designation |
SENIOR RESEARCH FELLOW |
| Affiliation |
CENTRAL UNIVERSITY OF KERALA |
| Address |
Department of Yoga Studies, School of Medicine and Public Health, Central University of Kerala Tejaswini Hills, CUK Campus Po, Kasaragod Kasaragod KERALA 671325 India |
| Phone |
9475453485 |
| Fax |
|
| Email |
sushilprasadmahato.2302207001@cukerala.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Yoga Studies, School of Medicine and Public Health, Central University of Kerala, Tejaswini Hills, CUK Campus PO, Kasaragod Dist, Kerala, India- 671325 |
|
|
Primary Sponsor
|
| Name |
Central University of Kerala |
| Address |
Department of yoga Studies, School of Medicine and Public Health, Central University of Kerala, Tejaswini Hills, Kasaragod Dist, Kerala, Inida- 671325 |
| Type of Sponsor |
Other [Department of Yoga Studies] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Office of the Principal |
Vinaya Bhavana Visva Bharati Santiniketan West Bengal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samiran Mondal |
Pearson Memorial Hospital |
Indian Knowledge System Laboratory, Department of Yogic Art & Science, Vinaya Bhavana, Visva-Bharati, Santiniketan, West Bengal- 731235 Birbhum WEST BENGAL |
9434220938
samiran.mondal@visva-bharati.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Procedure | - | Meditation | (Procedure Reference: , Procedure details: Heartfulness Meditation for 30 Minutes for 5 day of week)
| | 2 | Comparator Arm (Non Ayurveda) | Procedure | - | | Heartfulness Meditation for 30 Minutes for 5 day of week |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Volunteers |
|
| ExclusionCriteria |
| Details |
(i) current or past neurological disorders (e.g., epilepsy, traumatic brain injury) or major psychiatric illness; (ii) use of psychoactive medication, alcohol, or recreational drugs likely to affect electrophysiological measures; (iii) dermatological or scalp conditions precluding electrode placement; and (iv) uncorrected hearing deficits that could interfere with bell sound engagement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in brain wave activity (EEG patterns) after intervention with Heartfulness Meditation and Bell |
Baseline and After compte of 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cognitive Assessment |
Base Line & after complete of 12 weeks of Intervention |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 randomized controlled trial aims to evaluate the effects of Heartfulness Meditation and Bell Meditation on brain wave activity, cognitive functions, and emotional intelligence among university students. A total of 3 groups will be included in the study: Heartfulness Meditation group, Bell Meditation group, and a control group. Participants will be randomly assigned to each group. Pre- and post-assessments will be conducted using EEG recordings and standardized psychological tools. The study seeks to explore whether meditation practices can enhance mental and emotional well-being in young adults. |