| 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
|
|
|
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
|
|
|
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. |