NCT06778889

Brief Summary

Brief Summary The goal of this observational study is to understand how physical activity affects mental health and perceived stress in undergraduate medical students in Pakistan. The main questions it aims to answer are: Does physical activity improve the mental health of medical students? Does physical activity lower the stress levels of medical students? Researchers will compare students who engage in physical activity to those who do not to see if physical activity improves their mental health and reduces stress. Participants will: Complete surveys about their mental health and perceived stress. Report their physical activity levels, including how often they exercise and for how long. This study will help identify how lifestyle changes, like exercising, can improve the well-being of medical students and potentially reduce the challenges they face during their education.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 3, 2025

Last Update Submit

January 14, 2025

Conditions

Keywords

Mental Health profilePerceived StressMedical studentsPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Mental Health Status of Undergraduate Medical Students

    The primary outcome measure is to assess the mental health status of undergraduate medical students using the Brief Symptom Inventory-18 (BSI-18), which assesses psychological distress across three subscales: anxiety, depression, and somatization. The BSI-18 uses a 5-point Likert scale, where 0 = "not at all" and 4 = "extremely," to measure each symptom's intensity. The Global Severity Index (GSI) is calculated from the total score across all subscales, with higher scores indicating higher distress. The subscale scores for anxiety, depression, and somatization range from 0 to 24, where higher scores reflect greater psychological discomfort. Minimum value: 0 (indicating no distress)Maximum value: 24 (indicating extreme distress) In addition to raw scores, the BSI-18 also provides T-scores (mean = 50, SD = 10) for each subscale, allowing for comparison across populations regardless of their distribution. Higher T-scores indicate more significant distress.

    Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.

Secondary Outcomes (1)

  • Perceived Stress Levels among Undergraduate Medical Students.

    Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.

Other Outcomes (1)

  • Physical Activity Levels of Undergraduate Medical Students

    Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.

Study Arms (1)

Undergraduate Medical Students

This cohort consists of undergraduate medical students enrolled in the medical program. They will be assessed for their physical activity levels, perceived stress, and mental health.

Behavioral: Undergraduate Medical Students

Interventions

This is an observational study without any intervention. Data will be collected using standardized questionnaires to assess physical activity, mental health, and stress levels in the participants.

Undergraduate Medical Students

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study will target undergraduate medical students aged 18-30 years from various institutions. The population will include both male and female students, ensuring a comprehensive analysis of mental health, perceived stress, and physical activity.

You may qualify if:

  • Undergraduate medical students from any academic year.
  • Students who are willing to participate and provide informed consent.
  • Students who engage in physical activity (any frequency or duration) within the last month

You may not qualify if:

  • Students who do not provide informed consent.
  • Students with physical disabilities or medical conditions that prevent participation in physical activity (e.g., severe cardiovascular conditions, musculoskeletal disorders).
  • Students with a diagnosed mental health disorder that may interfere with the study's focus on stress and mental health (e.g., schizophrenia, bipolar disorder).
  • Students with language barriers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karachi medical and dental college

Karachi, Sindh, 74600, Pakistan

Location

MeSH Terms

Conditions

Psychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Nazeer Ahmed, MBBS

    Karachi medical and dental college karachi Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Final year medical student

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 16, 2025

Study Start

February 2, 2024

Primary Completion

October 2, 2024

Study Completion

October 2, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that support the findings of this study will be shared, including data related to mental health profiles, perceived stress levels, and physical activity levels obtained from BSI-18, PSS-10, and IPAQ-7 questionnaires.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The IPD and supporting information will be available starting 6 months after publication and will remain accessible for 5 years.
Access Criteria
Researchers who provide a methodologically sound proposal to investigate questions relevant to the study objectives will have access. Proposals should be directed nazeermed313@gmail.com. Data will be made available through a secure online repository after approval.

Available IPD Datasets

Study Protocol Access

Locations