| CTRI Number |
CTRI/2025/11/098097 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Health Education Program to reduce Lonliness among Medical Students |
|
Scientific Title of Study
|
Health education intervention to address loneliness among Indian medical graduates
and assessing its impact on Quality of life: A Randomised 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 |
soham raj |
| Designation |
UG student |
| Affiliation |
GSVM Medical College kanpur |
| Address |
Department of Community Medicine GSVM Medical College Swaroop Nagar, kanpur, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8287851282 |
| Fax |
|
| Email |
sohamraj44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanu Midha |
| Designation |
professor |
| Affiliation |
GSVM medical college kanpur |
| Address |
Department of Community Medicine
GSVM medical college, kanpur,
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9336818435 |
| Fax |
|
| Email |
tanumidha2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanu Midha |
| Designation |
professor |
| Affiliation |
GSVM medical college kanpur |
| Address |
Department of Community Medicine
GSVM medical college, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9336818435 |
| Fax |
|
| Email |
tanumidha2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine
GSVM MEDICAL COLLEGE Swaroop nagar,Kanpur, UP,208002 India |
|
|
Primary Sponsor
|
| Name |
SOHAM RAJ |
| Address |
Department of Community Medicine
GSVM Medcial College
Swaroop Nagar Kanpur
Uttar pradesh
India 208002 |
| 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 |
| SOHAM RAJ |
GSVM MEDICAL COLLEGE |
DEPARTMENT OF COMMUNITY MEDCINE
GSVM MEDICAL COLLEGE SWAROOP NAGAR KANPUR UTTARPRADESH 208002
Kanpur Nagar
UTTAR PRADESH |
8287851282
sohamraj44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
LONLINESS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lonliness among IMG |
The total duration of the intervention is 8 weeks. Group A will receive one health- education seminar per week, for a total of 8 seminar over 2 months. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Medical students enrolled in the MBBS as per CBME curriculum.
2. Medical students between 18 to 28 years of age.
3. Medical students willing to participate as per the consent form given. |
|
| ExclusionCriteria |
| Details |
1. Medical students who are less than 18 years and more than 28 years of age.
2. Medical students who are not willing to give consent.
3. Those who are having preexisting psychiatric illnesses like bipolar disorder,
schizophrenia, etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will help in understanding the cause of social isolation and identifying a health
education intervention for loneliness among the young generation and its relation with
academic performance and other health issues. |
baseline (day 0), 4 weeks after start ofintervention and 8 weeks(end of intervention). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To investigate demographic & socio-economic factors that may moderate the impact
of loneliness on quality of life.
2. To evaluate the effectiveness of existing social support systems & coping
mechanisms among Indian youth in mitigating the effects of loneliness.
3. To identify changes in loneliness & quality of life scores over the two-year period,
and to explore any seasonal or temporal variations. |
baseline (day 0) & 8 weeks (end of intervention) |
|
|
Target Sample Size
|
Total Sample Size="625"
Sample Size from India="625"
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)
|
12/12/2025 |
| 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="4"
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
|
This randomized controlled trial aims to evaluate the effectiveness of a structured health education intervention in reducing loneliness and improving quality of life among Indian medical graduates. Loneliness has been identified as a common psychological issue in this population due to academic pressure, relocation, long working hours, and limited social interaction.
A total of 625 participants will be enrolled and randomly allocated into intervention and control groups. The intervention group will receive a planned health education program consisting of weekly sessions focused on social connectedness, coping strategies, stress management, and communication skills. The control group will not receive any intervention during the study period.
Loneliness will be assessed using the UCLA Loneliness Scale Version 3 and quality of life will be measured using the WHOQOL BREF questionnaire. Assessments will be conducted at baseline and after three months of follow up. The primary outcome is change in loneliness scores. Secondary outcomes include changes in quality of life and the association of these outcomes with demographic factors.
This study is expected to provide evidence on the role of health education in addressing loneliness among medical graduates and improving their overall well being. |