FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083574 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Testing whether a short online mindfulness training program can help medical students reduce stress and exam anxiety, and improve academic performance 
Scientific Title of Study   Effectiveness and Feasibility of Brief Online Mindfulness Training in Medical Students to Contain Stress, Exam Anxiety, and Improve Academic Performance 
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 Bharath Reddy A R 
Designation  Junior Resident, Department of Psychiatry 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education 
Address  Department of Psychiatry, Kasturba Medical College, Attavar Hospital, Attavar, Mangalore – 575001, Karnataka, India.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8123798450  
Fax    
Email  bharathreddy.383@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Keshava Pai 
Designation  Professor, Department of Psychiatry 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education 
Address  Department of Psychiatry, Kasturba Medical College, Attavar Hospital, Attavar, Mangalore – 575001, Karnataka, India.


KARNATAKA
575001
India 
Phone  8123798450  
Fax    
Email  pai.keshava@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bharath Reddy A R 
Designation  Junior Resident, Department of Psychiatry 
Affiliation  Kasturba Medical College, Mangalore, Manipal Academy of Higher Education 
Address  Department of Psychiatry, Kasturba Medical College, Attavar Hospital, Attavar, Mangalore – 575001, Karnataka, India.


KARNATAKA
575001
India 
Phone  8123798450  
Fax    
Email  bharathreddy.383@gmail.com  
 
Source of Monetary or Material Support  
No external funding Kasturba Medical College, Mangalore Department of Psychiatry Light House Hill Road, Mangalore, Karnataka, India - 575001 
 
Primary Sponsor  
Name  Kasturba Medical College, Mangalore 
Address  Light House Hill Road, Mangalore - 575001 
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 Bharath Reddy A R  KMC Attavar Hospital  Room number:14, Department of Psychiatry, KMC Attavar Hospital Attavar, Mangalore, Dakshina Kannada Karnataka, India - 575001
Dakshina Kannada
KARNATAKA 		 8123798450

bharathreddy.383@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ICD-11 Code: QD85 - Work-related stress disorde 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief Online Mindfulness Training  An 8-week structured online mindfulness program including video-based instruction and guided mindfulness practices. Participants will engage in 5-minute daily mindfulness exercises, with assessments at baseline, post-intervention, and 4-month follow-up. 
Comparator Agent  NOT APPLICABLE  This is a single-arm trial. No comparator agent is used 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  First-year MBBS students studying at Kasturba Medical College, Mangalore.
Students with no prior formal mindfulness training.
Willing to provide informed consent. 
 
ExclusionCriteria 
Details  Students currently or previously under pharmacotherapy or psychotherapy for any psychiatric disorder.
Students with prior formal mindfulness training.
Students unwilling to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in perceived stress and exam anxiety after brief online mindfulness training.
Improvement in mindfulness traits after the intervention. 		 Baseline (Before intervention)
Immediately after 8 weeks of training
Follow-up at 4 months (if applicable) 
 
Secondary Outcome  
Outcome  TimePoints 
Impact on academic performance (exam scores).
Change in subjective well-being. 		 Baseline (Pre-Intervention): Before the second sessional exam.
Post-Intervention (Week 8): Before the third sessional exam.
Follow-up (4 months after intervention): Final assessment four months post-intervention. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   09/04/2025 
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="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  

Title:

Effectiveness and Feasibility of Brief Online Mindfulness Training in Medical Students to Contain Stress, Exam Anxiety, and Improve Academic Performance

Background:

Medical students experience high levels of stress and exam anxiety, which can negatively impact their academic performance and mental well-being. Mindfulness training has been shown to improve emotional regulation and reduce stress levels.

Objective:

To evaluate the effectiveness and feasibility of a brief online mindfulness training program in reducing stress and exam anxiety among medical students.

Methods:

A non-randomized controlled trial will be conducted among first-year MBBS students at Kasturba Medical College, Mangalore. Participants will undergo an 8-week online mindfulness training program. The primary outcomes include changes in perceived stress, exam anxiety, and mindfulness traits, measured using validated scales. Assessments will be conducted at baseline, post-intervention, and at 4-month follow-up.

Expected Outcomes:

The study aims to determine whether brief online mindfulness training can significantly reduce stress and exam anxiety while improving mindfulness levels among medical students.

Conclusion:

Findings from this study may help in incorporating mindfulness interventions as part of academic well-being programs for medical students.

 
Close