| CTRI Number |
CTRI/2025/08/092302 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sookshma mediation] |
| Study Design |
Other |
|
Public Title of Study
|
Benefits of practice of sookshma meditation on sleep and stres in medical students |
|
Scientific Title of Study
|
The Impact of Sookshma Meditation on Sleep Quality and Psychological Distress in MBBS Students: A Comprehensive Analysis |
| 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 Swikruti Behera |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata Medical College
Kadani Road
Baridih
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
8332918887 |
| Fax |
|
| Email |
swikruti.behera@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swikruti Behera |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata Medical College
Kadani Road
Baridih
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
8332918887 |
| Fax |
|
| Email |
swikruti.behera@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Swikruti Behera |
| Designation |
Professor |
| Affiliation |
Manipal Tata Medical College |
| Address |
Department of Physiology
Manipal Tata Medical College
Kadani Road
Baridih
Purbi Singhbhum JHARKHAND 831017 India |
| Phone |
8332918887 |
| Fax |
|
| Email |
swikruti.behera@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Swikruti Behera |
| Address |
Professor and Head
Department of Physiology
Manipal Tata Medical College
Kadan Road
Baridih
Jamshedpur 831017 |
| Type of Sponsor |
Other [Self] |
|
|
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 Swikruti Behera |
Manipal Tata Medical College |
Department of Physiology
Manipal Tata medical College
Kadani Road, Baridih, Jamshedpur Purbi Singhbhum JHARKHAND |
8332918887
swikruti.behera@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal Tata Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers willing to practice sookshma meditation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sookshma Meditation |
Practice of Sookshma Meditation for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
All apparently healthy student Volunteers willing to participate and practice sookshma meditation. |
|
| ExclusionCriteria |
| Details |
Nonconsenting students, students having fever and/or any chronic illness will be excluded from the study. Students taking any form of medication for any chronic or acute condition will also be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact on sleep quality and psychological distress upon 4 week practice of sookshma meditation. |
Impact on sleep quality and psychological distress upon 4 week practice of sookshma meditation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
02/09/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Health and well being : It will help the medical students to
handle stress more effectively and have a quality sleep which will in turn
prepare them for future. It will also ensure good mental and physical health
in the long run.
Sleep and stress : sleep and stress are not only interconnected they are also
interdependent on each other. Poor sleep and psychological distress can lead
to various diseases which may include metabolic and non-metabolic ones. It can
also affect psychological and cognitive function in the long run.
Sookshma Meditation : Effect of meditation on MBBS students are also very
scarce. Moreover, Sookshma Meditation is a very new technique which has shown
promising result and very literature on its scientific benefits is almost nil.
Meditation is a cost effective but has been proven to be helpful in various
sectors which can help the medical students in handling stress and long
working hours.
Scientific contribution : This study will add to the existing scientific
literature by providing more insights through newer meditation techniques like
Sookshma meditation. It aims to provide evidence which can help in modifying
or planning medical education and its policies in future. |