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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shruti.niraj@smsimsr.org].

  6. 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.

  7. 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.

 
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