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CTRI Number  CTRI/2025/03/083718 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Mindfulness based Resilience Training]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Mindfulness Based Resilience Training on Stress, Burnout, and Well-being Among Nurses in a Tertiary Care Hospital 
Scientific Title of Study   Effectiveness of Mindfulness Based Resilience Training on Occupational Burnout, Stress, Coping Strategies, and Biophysiological Parameters Among Staff Nurses in a Selected Tertiary Care Centre: A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KALAIYARASI B 
Designation  Ph.D. Scholar (Nursing – Full-Time) 
Affiliation  SRM College of Nursing 
Address  Room No. 108, Department of Nursing Research, SRM College of Nursing, SRM Institute of Science and Technology (SRMIST), Kattankulathur Campus, Chengalpattu District.

Kancheepuram
TAMIL NADU
603 203
India 
Phone  8072426032  
Fax    
Email  priyaakalai19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Helen Shaji JC 
Designation  Dean Cum Professor 
Affiliation  SRM College of Nursing 
Address  Room No.1,SRM College of Nursing,SRM Institute of Science and Technology(SRMIST),Kattankulathur Campus, Chengalpattu District.

Kancheepuram
TAMIL NADU
603203
India 
Phone  9383880999  
Fax    
Email  helenshj@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Selvamary Devakani J 
Designation  Assistant Professor 
Affiliation   
Address  Room No.201,SRM College of Nursing,SRM Institute of Science and Technology(SRMIST),Kattankulathur Campus, Chengalpattu District.

Kancheepuram
TAMIL NADU
603203
India 
Phone  8608760886  
Fax    
Email  selvamaj@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology – SRM Department of Medical Research, SRM College of Nursing, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu District. PIN Code – 603 203. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
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 Venkatraman R  SRM Medical College Hospital & Research Centre.  Room No.5, Medical Superintendent, SRM MCH & RC, Kattankulathur-603203.
Kancheepuram
TAMIL NADU 		 984581455

drvenkat94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SRM Medical College Hospital & Research Centre, Kattankulathur, Chengalpattu District- 603203.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F430||Acute stress reaction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group (Standard Care or Waitlist Control)  The control group will receive standard institutional stress management resources or routine workplace support without additional mindfulness-based resilience training. 
Intervention  Mindfulness based Resilience Training  Experimental Group:MINDFULNESS- BASED RESILIENCE TRAINING (MBRT) : MBRT such as (1& 2nd week) Introduction to Mindfulness breathing exercise - (3rd & 4th week) - Mindfulness thought labelling and emotional check in & Mindfulness eating and meditation, (5th & 6th week) - Mindfulness Visualization-Guided imagery technique & Mindfulness overcoming fear of failure, (7th & 8th week) - Mindfulness Gratitude of Journaling and meditation & Mindfulness in daily life. Resilience training including lecture and practical session will be given 45 minutes in a group session and video information of each session will be sent to all participants. Every session First day the researcher will demonstrate and the second day participants will practice under the guidance of researcher. Rest of the days,the researcher will motivate the participants to practice at home through telephone reminder and up to 9 - 12 weeks reinforcement will be extended. 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Registered nurses between the age group of 23–50 years.

2.Both male and female staff nurses.

3.Registered nurses with a professional experience of one year and above.

4.Staff nurses willing to participate in the study. 
 
ExclusionCriteria 
Details  1.Nurses who had taken leave of more than one year were excluded from the study.

2.Nurses who participated in any stress reduction program in the last six months. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Occupational Burnout – Measured using the Maslach Burnout Inventory (MBI).

Stress Levels – Assessed using the Perceived Stress Scale (PSS).

Coping Strategies – Evaluated through the Brief COPE Questionnaire.

Biophysiological Parameters – Includes blood pressure and salivary cortisol levels. 		 Baseline (Before intervention)

8 Weeks (Post-intervention assessment)

12 Weeks (Follow-up assessment) 
 
Secondary Outcome  
Outcome  TimePoints 
Occupational Burnout – Reassessed using a validated burnout scale (MBI) at follow-up.

Stress Levels – Reassessed using a standardized Perceived Stress Scale at follow-up.

Coping Strategies – Reassessed through a standardized Brief COPE questionnaire at follow-up.

Biophysiological Parameters – Includes blood pressure & salivary cortisol levels, reassessed at follow-up. 		 Baseline (Pre-intervention).

8 Weeks Post-Intervention.

12 Weeks Post-Intervention. 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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 3 
Date of First Enrollment (India)   15/04/2025 
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="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyaakalai19@gmail.com].

  6. For how long will this data be available start date provided 10-01-2027 and end date provided 11-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		  This randomized controlled trial aims to evaluate the effectiveness of Mindfulness-Based Resilience Training (MBRT) in reducing occupational burnout and stress while enhancing adaptive coping strategies among staff nurses. Additionally, the study seeks to maintain normal biophysiological parameters, such as blood pressure and cortisol levels. By fostering resilience, mindfulness, and emotional regulation, the intervention is expected to improve job satisfaction, well-being, work engagement, and overall quality of life.

Participants will be randomly assigned to either the experimental group, which will receive MBRT, or the control group, which will continue with routine support measures.

Data Collection and Assessment:
Participants will be screened using validated scales, including the Maslach Burnout Inventory, Perceived Stress Scale, Brief COPE Scale, and salivary cortisol levels.

Baseline Assessment Includes:

  • Blood Pressure Monitoring: Evaluating the physiological response to stress and the impact of MBRT.
  • Salivary Cortisol Levels: Measuring cortisol levels to assess stress and the physiological effects of MBRT on stress regulation.
  • Coping Strategies: Assessing changes in stress management using the Nursing Workplace Coping Scale.

Outcome Measurement:

  • Post-Test 1: Conducted immediately after the intervention.
  • Post-Test 2: Conducted 12 weeks after the intervention to assess long-term effects.

Study Outcomes:

  • Primary Outcomes: Occupational burnout, stress levels, and coping strategies.
  • Secondary Outcomes: Physiological changes, including blood pressure and salivary cortisol levels.

This study aims to provide evidence on the effectiveness of MBRT in promoting resilience and well-being among nurses in a high-stress healthcare environment.

 
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