| CTRI Number |
CTRI/2024/07/071645 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Meditation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Transcendental Meditation for healthcare professionals |
|
Scientific Title of Study
|
An open-label, prospective, randomized controlled, single-centre pilot study evaluating the acceptability, feasibility and exploratory efficacy of transcendental meditation intervention for healthcare professionals in a tertiary care hospital in rural Jndia. |
| 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 Rajesh Naithani |
| Designation |
Director of Collaborative Research |
| Affiliation |
Sri Sathya Sai University for Human Excellence |
| 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 |
9952903987 |
| Fax |
|
| Email |
advisortohrm@gmail.com |
|
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 Sai Institute of Medical Sciences and Research
Muddenahalli
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 Sai Institute of Medical Sciences and Research
Muddenahalli
Bangalore Rural KARNATAKA 562101 India |
| Phone |
9901729001 |
| Fax |
|
| Email |
shruti.niraj@smsimsr.org |
|
|
Source of Monetary or Material Support
|
| Sri Madhusudan Sai Institute of Medical Sciences and Research
Muddenahalli, Chikkaballapur
Karnataka, India
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 |
9901729001
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 Group A will receive 5 days of instruction in Transcendental Meditation (TM). 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 |
| Comparator Agent |
Wellness resources |
Group B will act as control arm. The participants in this group will be given access to wellness resources for the duration of the study period of 3 months. The resources will include self-help information on relaxation and stress management. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Fulltime healthcare providers, medical doctors or nurses involved in active patient care or direct hospital administration.
2. 18 years or older
3. Willing to complete both baseline and post-testing
4. In the active treatment group, willing to dedicate the time required to learn the TM technique and practicing it twice daily for 20 minutes each time
|
|
| ExclusionCriteria |
| Details |
1. Already instructed in the TM technique
2. Currently unstable psychiatric symptoms as demonstrated by self-report, medical chart, or psychiatric hospitalizations in the past six months
3. Use of antipsychotic or β blocker medications
4. current suicidal ideation |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility and acceptability of TM |
Baseline and 3-month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Perceived Stress Scale-4 (PSS-4)
2. Generalised Anxiety Disorder Scale (GAD-7)
3. Short Warwick Edinburgh Mental Well Being Scale (S-WEMWBS)
4. The Copenhagen Burnout Inventory (CBI)
5. EEG |
Baseline and 3-month follow up |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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) |
Closed to Recruitment of Participants |
|
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 28-02-2025 and end date provided 28-02-2028?
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: Health Care Professionals (HCPs) experience substantial stress, anxiety and burnout, with recently reported burnout rates of 60% to 70%. The World Health Organization (WHO) defines burnout as an occupational phenomenon resulting from chronic workplace stress that has not been successfully managed. Several randomized clinical trials have evaluated strategies to reduce stress and burnout, such as the use of psychological or sensory-emotional techniques, group discussions, mindfulness or compassion-based programs, auricular acupressure, and cannabidiol treatment. These studies reported short-term improvements; however, small cohorts, high attrition rates, lack of sample diversity, or the need for pharmacological therapy have limited their utility, highlighting the need for rigorously tested interventions for burnout, anxiety, and stress.1 Transcendental Meditation (TM) is an evidence-based meditation practice in which individuals silently recite a single mantra (a sound that lacks meaning) without concentration or contemplation. Studies on TM practitioners have revealed patterns of increased parasympathetic response leading to attenuation of the stress response. Clinical trials have demonstrated that the efficacy of TM for the reduction of stress and burnout among teachers3 and emergency department clinicians4. The practice of TM has been found to reduce post-traumatic stress disorder symptoms in veterans 5,6, which might be particularly relevant because recent reports of HCW burnout suggest a similarity to the experiences of combat veterans.7 Aims/Objectives: The primary aim of the study is to evaluate whether engaging in TM intervention is feasible and acceptable for HCPs. The secondary aims are to assess change in measures of wellbeing, burnout, anxiety and stress at baseline, at 1-month and at 3-month follow-up. Methodology: This is an open-label, prospective, randomized, controlled, single-centered study based in a tertiary care hospital in Rural India. Healthcare professionals will be randomized using stratified randomization based on age (<40 years vs ≥40 years), gender (male vs female) and medical profession (doctors vs nurses) into study groups A & B. Group A will receive Transcendental Meditation and group B will act as control who will have access to wellness resources. The study will assess whether engaging in TM intervention is feasible and acceptable for HCPs measured by self-report questionnaires. Validated and reliable outcome measures of wellbeing, burnout, anxiety, and stress will be collected at baseline and at 3-month follow-up. |