| CTRI Number |
CTRI/2025/12/098585 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how Nadanusandhana Meditation changes cognitive skills, and brain function, psychological well-being in adolescents. |
|
Scientific Title of Study
|
The Impact of Nadanusandhana Meditation on Cognitive Functions,
Psychological Parameters, and Dynamic Brain Activity in High School Students: A
Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abinash Roy |
| Designation |
Ph.D. Scholar |
| Affiliation |
Central University of Kerala |
| Address |
Room No. 01, Department of Yoga Studies, Yamuna Block, Central University of Kerala, Tejaswini Hills, Periya PO, Kasaragod Dist., Kerala, 671325
Kasaragod
KERALA
671325
India |
| Phone |
8761008738 |
| Fax |
|
| Email |
abinashroy53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Subramanya Pailoor |
| Designation |
Professor |
| Affiliation |
Central University of Kerala |
| Address |
Room No. 7, Department of Yoga Studies, Yamuna Block, Central University of Kerala, Tejaswini Hills, Periya PO, Kasaragod Dist., Kerala, 671325
Kasaragod
KERALA
671325
India |
| Phone |
9886462201 |
| Fax |
|
| Email |
pailoors@cukerala.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Abinash Roy |
| Designation |
Ph.D. Scholar |
| Affiliation |
Central University of Kerala |
| Address |
Room No. 01, Department of Yoga Studies, Yamuna Block, Central University of Kerala, Tejaswini Hills, Periya PO, Kasaragod Dist., Kerala, 671325
Kasaragod
KERALA
671325
India |
| Phone |
8761008738 |
| Fax |
|
| Email |
abinashroy53@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vivekananda Kendra Vidyalaya Tinsukia, Assam |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Abinash Roy |
Vivekananda Kendra Vidyalaya (VKV) Tinsukia |
Vivekananda Kendra Vidyalaya (VKV) Tinsukia VKPratisthan Campus, Laipuli Tinsukia, Assam – 786183
Tinsukia
ASSAM |
8761008738
abinashroy53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (IHEC), Central University of Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitive Enhancement and Psychological Well-being |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nadanusandhana Meditation |
35 minutes of Nadanusandhana meditation (A yoga based meditation) for 48 days (8 weeks), 6 days a week
|
| Comparator Agent |
Wait-List Control |
No intervention, resumes regular activities |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
(1) Participants must be aged 12 to 18 years.
(2) Individuals must express a voluntary willingness to participate in the study and provide informed consent.
(3) Participants should be in good general health.
|
|
| ExclusionCriteria |
| Details |
(1) Individuals with previous exposure to meditation in the last 6 months will be excluded.
(2) Individuals diagnosed with psychological conditions, such as stress or anxiety disorders, will not be eligible.
(3) Participants with medical conditions that conflict with computerised tests or EEG measurements will be excluded.
(4) Those currently taking medications that affect cognition or EEG readings will not be eligible for participation.
(5) Individuals with ear issues that affect auditory perception will be excluded.
|
|
|
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 |
Sustained attention
Working memory capacity
Mindfulness
Emotion regulation
EEG brain wave data |
Baseline and Post-Intervention (After 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
12/02/2026 |
| Date of First Enrollment (Global) |
10/12/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="20" |
|
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 study is a prospective, parallel-group, two-arm Randomized Controlled Trial (RCT). The study aims to evaluate the efficacy of an 8-week meditation intervention on the overall well-being of healthy students (adolescents). A total of 84 participants will be recruited and randomized (1:1 allocation) into either the Intervention Group, which practices the 35-minute Nadanusandhana Meditation module daily for 8 weeks (48 days), or the Wait-List Control Group, which continues with standard school activities. Primary outcomes will be assessed at Baseline and Post-Intervention (End of Week 8) across three key domains: Cognitive Functions, Psychological Parameters, and EEG Brain wave. Data will be analyzed to compare changes between groups over time, with a focus on providing scientific, neurophysiological evidence for Nadanusandhana Meditation as a non-pharmacological strategy to enhance cognitive and psychological well being in adolescent students. |