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CTRI Number  CTRI/2025/07/090621 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Integrating Mind, Body and Spirit: A Quasi-Experimental Study on the Impact of a Holistic Wellness Program on Mental Wellbeing among Medical Students in a Tertiary Care Teaching Hospital in South India 
Scientific Title of Study   Integrating Mind, Body and Spirit: A Quasi-Experimental Study on the Impact of a Holistic Wellness Program on Mental Wellbeing among Medical Students in a Tertiary Care Teaching Hospital in South India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nivasini Natarajan Thangam 
Designation  POSTGRADUATE Resident Doctor 
Affiliation  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  Department of Pharmacology SRM Medical College Hospital and Research Centre SRM Nagar, Potheri, Kattankulathur

Chennai
TAMIL NADU
603211
India 
Phone  9176500442  
Fax    
Email  nivasini.natarajan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jamuna Rani 
Designation  Professor and Head of the Department of Pharmacology 
Affiliation  SRM Medical college Hospital and Research Centre 
Address  Department of Pharmacology, SRM Medical College Hospital and Research Centre SRM Nagar Potheri Kattankulathur

Chennai
TAMIL NADU
603211
India 
Phone  9840279010  
Fax    
Email  hod.phacol.ktr.med@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Jamuna Rani 
Designation  Professor and Head of the Department of Pharmacology 
Affiliation  SRM Medical college Hospital and Research Centre 
Address  Department of Pharmacology, SRM Medical College Hospital and Research Centre SRM Nagar Potheri Kattankulathur


TAMIL NADU
603211
India 
Phone  9840279010  
Fax    
Email  hod.phacol.ktr.med@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Medical College Hospital And Research Centre,SRM Nagar, Kattankulathur, Tamilnadu 603203, India 
 
Primary Sponsor  
Name  Dr Natarajan Thangam Nivasini  
Address  Department of Pharmacology SRM Medical College Hospital And Research Centre,SRM Nagar, Kattankulathur, Tamilnadu 603203, India 
Type of Sponsor  Other [Self] 
 
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 Jamuna Rani  SRM Medical College Hospital and Research Centre  SRM Nagar, Potheri, Chengalpattu, Tamil Nadu 603203
Chennai
TAMIL NADU 
9840279010

hod.phacol.ktr.med@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Students,SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY PARTICIPANTS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mindfulness meditation, morning gratitude, gratitude diary, stress management workshops,yoga, aerobic exercises and nutrition education  The participants who fall in the inclusion criteria after preintervention with the above-mentioned scales will be introduced to the wellness program. Mindfulness meditation, morning gratitude, gratitude diary, stress management workshops, and cognitive behavioural techniques and peer support groups. 2. Body: Physical activity sessions such as yoga, aerobic exercises and nutrition education. 3. Spirit: Reflective practices, guided imagery and spiritual care workshops. The following questionnaires, WHO (Five) Well-being Index, General Health Questionnaire (GHQ-12), Perceived Stress Scale and Depression Anxiety Stress Scales (DASS-21) will be analyzed at the baseline and 6 months after the intervention.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Medical students enrolled in the institution
Willing to participate in the study
 
 
ExclusionCriteria 
Details  Not willing to participate in the study
Preexisting mental illness on treatment
Medical students from other institutions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of the holistic wellness program on the mental well-being of second-year MBBS students by comparing changes in pre and post-intervention scores on the WHO (Five) Well-being Index and General Health Questionnaire (GHQ-12)
 
6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the effectiveness of a wellness program in improving the academic performance of medical students by comparing the internal assessment marks pre & post- intervention
2.To assess changes in stress, anxiety & depression by comparing changes in pre & post-intervention scores on the Perceived Stress Scale (PSS) & Depression Anxiety Stress Scales (DASS-21)
3.To assess the quality of life by analysing sleep-wake patterns & physical activity levels pre & post-intervention
4.To access changes in anthropometric measurements, such as BMI
5.To assess the feasibility & acceptability of the holistic wellness program in a medical education setting
 
6 Months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/08/2025 
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 Applicable 
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  

Mental health was defined by World Health Organization (WHO) as “a state of well-being whereby individuals recognize their abilities, be able to cope with the normal stress of life, work productively and faithfully, and make a contribution to their communities”. About 500 million people suffer from mental disorders worldwide. Young people are more likely to experience mental illness than any other age group. In recent decades, the prevalence of mental health issues among college students has been on the rise and it poses a major challenge for public health professionals who are interested in establishing an effective response to these issues. Researchers showed that the prevalence of mental disorders among medical students is more likely to be higher than that of other college students as well as the general population.

Medical students frequently experience significant levels of stress, anxiety and burnout due to academic pressure, long study hours, rigorous clinical responsibilities, and uncertainty regarding their future careers. These challenges can adversely affect their mental well-being, resulting in problems such as sleep disturbances, emotional exhaustion and decreased academic performance. Consequently, this leads to elevated rates of depression, anxiety, burnout, and suicidal tendencies. Research indicates a high prevalence of suicides and serious mental health issues among medical students in India, demanding the urgent need for comprehensive support. Integrating holistic programs into the curriculum promotes resilience, enhances mental health outcomes and improves academic performance.

Holistic wellness programs that seamlessly integrate the mind, body, and spirit—encompassing mindfulness practices, physical activity, and stress management techniques—have garnered attention as effective interventions for enhancing mental health and overall well-being. These programs promote mental resilience, emotional stability, and physical health, offering a holistic approach to well-being instead of simply addressing isolated symptoms.

This quasi-experimental study seeks to evaluate the impact of a holistic wellness program on the mental well-being of medical students at a tertiary care teaching hospital in South India. By incorporating mindfulness, yoga, meditation, exercise and reflective practices, the study examines how a structured wellness program can improve stress management, emotional stability, and overall quality of life among future healthcare professionals.

 
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