| CTRI Number |
CTRI/2025/03/081804 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does Transcendental Meditation improve psychological wellbeing in healthcare students |
|
Scientific Title of Study
|
A pilot study to investigate the acceptability and potential efficacy of Transcendental Meditation on psychological wellbeing in healthcare students in a rural Indian tertiary-care hospital. |
| 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 Shruti Niraj |
| Designation |
Senior Clinical Psychologist |
| Affiliation |
Sri Madhusudan Sai Institute of Medical Sciences and Research |
| Address |
Room No. 2 Department of Psychiatry Sri Madhusudan Institute of Medical Sciences & Research Sri Sathya Sai University for Human Excellence
Muddenahalli
Chikkaballapur
Bangalore Rural
KARNATAKA
562101
India |
| Phone |
9901729001 |
| Fax |
|
| Email |
shruti.niraj@smsimsr.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Niraj |
| Designation |
Senior Clinical Psychologist |
| Affiliation |
Sri Madhusudan Sai Institute of Medical Sciences and Research |
| Address |
Room No. 2 Department of Psychiatry Sri Madhusudan Institute of Medical Sciences & Research Sri Sathya Sai University for Human Excellence
Muddenahalli
Chikkaballapur
Bangalore Rural
KARNATAKA
562101
India |
| Phone |
9901729001 |
| Fax |
|
| Email |
shruti.niraj@smsimsr.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Niraj |
| Designation |
Senior Clinical Psychologist |
| Affiliation |
Sri Madhusudan Sai Institute of Medical Sciences and Research |
| Address |
Room No. 2 Department of Psychiatry Sri Madhusudan Institute of Medical Sciences & Research Sri Sathya Sai University for Human Excellence
Muddenahalli
Chikkaballapur
Bangalore Rural
KARNATAKA
562101
India |
| Phone |
9901729001 |
| Fax |
|
| Email |
shruti.niraj@smsimsr.org |
|
|
Source of Monetary or Material Support
|
| SMSIMSR, Sri Sathya Sai University for Human Excellence Muddenahalli, Chikkaballapur, Karnataka, 562101 |
|
|
Primary Sponsor
|
| Name |
SMSIMSR, Sri Sathya Sai University for Human Excellence |
| Address |
SMSIMSR, Sri Sathya Sai University for Human Excellence Muddenahalli, Chikkaballapur, Karnataka, 562101 |
| Type of Sponsor |
Private medical college |
|
|
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 Shruti Niraj |
Sri Madhusudan Sai Institute of Medical Sciences and Research |
Department of Psychiatry Rajeshwari Block Sri Madhusudan Sai Institute of Medical Sciences and Research Muddenahalli, Chikkaballapur
Bangalore Rural
KARNATAKA
Bangalore Rural
KARNATAKA |
09901729001
shruti.niraj@smsimsr.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sathya University for Human Excellence |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcendental Meditation (TM) |
The participants from TM will receive 5 days of instruction. During Session 1, participants will receive introductory information regarding TM. Session 2 will comprise of one-on-one training from a certified TM teacher. Session 3 to 5 will be checking-in group meetings of an hour each. It will be followed by self-practice of 20 minutes twice daily. Validated and reliable outcome measures of wellbeing, burnout, anxiety, and stress will be collected at baseline and at 3-month follow-up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fulltime healthcare students (medical and paramedical)
2. 18 years or older
3. Willing to complete both baseline and post-testing
4. Willing to dedicate the time required to learn the TM technique and practicing it twice daily for 20
minutes each time |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility and acceptability of TM |
Baseline and 3-months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the scores to measure psychological distress viz.
i) The DASS-21
ii) WHO-5 Well-Being Index
|
Baseline and 3-months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
28/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shruti.niraj@smsimsr.org].
- For how long will this data be available start date provided 22-05-2025 and end date provided 28-05-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background: Healthcare students (Medical and Paramedical) face significant psychological stress due to the demanding nature of their academic programs, clinical responsibilities, and the high expectations placed on them. This stress can lead to various psychological issues such as anxiety, depression, burnout, and reduced quality of life. Recent studies have suggested that mind-body interventions like Transcendental Meditation (TM) may be effective in reducing stress and improving psychological well-being in student populations. TM is a simple, natural, and effortless technique practiced for 20 minutes twice daily while sitting comfortably with the eyes closed. It allows the mind to settle inward beyond thought to the most silent and peaceful level of consciousness, leading to profound relaxation, increased inner calm, and improved cognitive functioning.
Aims and Objectives of the study: The primary aim of this pilot study is to evaluate the acceptability of Transcendental Meditation for healthcare students. The secondary aim is to explore the exploratory effectiveness of Transcendental Meditation intervention in improving the overall wellbeing and reducing the perceived stress, anxiety and low mood amongst medical students.
Methodology: This is a pilot observational, single-arm study exploring the feasibility and acceptability of TM in healthcare students. The students will be taught TM by a qualified TM trainer. Validated and reliable outcome measures will be collected at baseline and 3-months follow-up.
|