| CTRI Number |
CTRI/2025/08/092645 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cyclic meditation and stress management among students |
|
Scientific Title of Study
|
Effect of Cyclic Meditation on Stress Levels, Anxiety, and Depression in Higher Secondary 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 |
Tanisha Gupta |
| Designation |
MSc student |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Vivekananda Road
Division of Yoga & Life science
Research Department
Kallabalu(Post)
Jigani
Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
6005925607 |
| Fax |
|
| Email |
tanisag172@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Asst. Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Division of Yoga & Life science
Anvesana Research Labs
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
09632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Nair |
| Designation |
Asst. Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Division of Yoga & Life science
Anvesana Research Labs
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
09632164777 |
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| Nav Vidya Hr. Sec. School
Dhalote,
Samba
Jammu Kashmir
India
Pin code: 184121 |
|
|
Primary Sponsor
|
| Name |
Dr Rajesh Nair |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana
Division of Yoga & Life science
Anvesana Research Labs
Vivekananda Road
Kallabalu(Post)
Jigani
Bengaluru
|
| Type of Sponsor |
Research institution |
|
|
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 Smita |
Nav Vidya Hr. Sec. School |
Department of Physical Education
IKS division
Dhalote,
Samba
Jammu Kashmir
India - 184121
Jammu
JAMMU & KASHMIR |
9596915058
smitasingh.id@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) - SVYASA |
Approved |
| Nav Vidya Hr. Sec. School |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyclic Mediation |
Series or slow movements, including Asanas and relaxation sessions, 45 min for 5 days/ week for one month duration |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
School students, both male and female
As Aage (15 to 18)
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Students with any serious health issues
Students having language barriers (English)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stress
Anxiety
Depression
Sleep Quality |
Baseline and at the end of one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
11/09/2025 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tanisag172@gmail.com].
- For how long will this data be available start date provided 25-11-2025 and end date provided 04-11-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aims to assess the effect of cyclic meditation on the stress, anxiety, and depression of higher secondary students. Intervention (Cyclic Meditation practice) will be of the duration of 40 minutes and 5 days/week, for one month |