Mental HealthNCT06778889
Assessing the Impacts of Physical Activity on Mental Health and Perceived Stress Among Undergraduate Medical Students in Pakistan
An observational study of Mental Health and Perceived Stress, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Perceived Stress, Physical Activity
- What is being tested?
- Undergraduate Medical Students
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 291 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Feb 2024to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impacts of Physical Activity on Mental Health and Perceived Stress Among Undergraduate Medical Students in Pakistan: a Cross-Sectional Study
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:
Read more
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.
Read the detailed description
Detailed Description
This observational, cross-sectional study investigates the relationship between physical activity and its effects on mental health and perceived stress among undergraduate medical students in Pakistan. The study aims to determine whether engaging in regular physical activity can improve psychological well-being and reduce perceived stress in this population, which is known to face significant academic and personal stressors during their medical education.
Study Objectives and Rationale
Medical students encounter a variety of stressors, including demanding coursework, clinical responsibilities, and personal challenges. This study aims to provide a quantitative assessment of how physical activity can mitigate these stressors and improve mental health outcomes. It hypothesizes that students engaging in higher levels of physical activity will exhibit better mental health and lower perceived stress.
Study Design and Methodology
Study Design:
Observational, cross-sectional study. Data collected at a single time point using validated self-reported questionnaires.
Study Setting:
The study was conducted in both public and private medical colleges across Pakistan, providing a diverse sample of participants.
Data Collection Tools:
International Physical Activity Questionnaire (IPAQ-7): Used to measure physical activity levels, categorized as low, moderate, or high based on MET-minutes per week. Perceived Stress Scale (PSS-10): Used to quantify perceived stress levels. Scores are categorized as low (0-13), moderate (14-26), and high (27-40). Brief Symptom Inventory (BSI-18): Measures psychological distress, including somatization, depression, and anxiety, with a composite Global Severity Index (GSI).
Data Collection Procedure:
Participants were invited to complete online surveys distributed via Google Forms. Data collected included demographic information, physical activity habits (frequency, intensity, duration), stress levels, and mental health status. All participants provided informed consent, and confidentiality was maintained throughout the study.
Data Analysis Plan:
Descriptive statistics: Used to summarize participant demographics, activity levels, and mental health profiles. Inferential statistics: Chi-square tests to assess associations between physical activity levels and stress/mental health outcomes. Regression analysis to examine the predictive role of physical activity on mental health and perceived stress, adjusting for confounding factors such as age, gender, and academic year.
Study Duration:
The study was conducted over six months, with data collection completed within this timeframe. Key Technical Considerations The IPAQ-7 questionnaire quantifies physical activity in MET-minutes per week, allowing categorization into low (<600 MET-minutes/week), moderate (600-3000 MET-minutes/week), and high (>3000 MET-minutes/week) activity levels. The BSI-18 generates individual scores for somatization, depression, and anxiety, and calculates a composite GSI score (range: 0-72), where higher scores indicate greater psychological distress. Statistical analysis will control for potential confounders, ensuring robust interpretation of results. Significance and Potential Impact
This study will provide evidence on how physical activity can improve mental health and reduce stress among medical students in Pakistan, a population particularly vulnerable to mental health challenges. Findings may inform the development of interventions and institutional policies that integrate physical activity into student support systems to promote psychological well-being and academic success.
- Conditions
- Mental Health, Perceived Stress, Physical Activity
- Being tested
- Undergraduate Medical Students
- Keywords
- Mental Health profile, Perceived Stress, Medical students, Physical activity
- Medical subject headings
- Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Undergraduate Medical StudentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Undergraduate Medical Students |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The secondary outcome measure is to assess the perceived stress levels of undergraduate medical students using the Perceived Stress Scale (PSS-10), which assesses perceived stress over the past month. The PSS-10 includes 10 items rated on a 5-point scale (0 = "never" to 4 = "very often"). The total score ranges from a minimum value of 0 (indicating no perceived stress) to a maximum value of 40 (indicating very high perceived stress). Higher scores represent worse outcomes, reflecting greater levels of perceived stress. The interpretation is as follows:
Low stress: 0-13 Moderate stress: 14-26 High stress: 27-40
Measured: Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start2 Feb 2024
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazeer Ahmed, Rawalpindi Medical College
- Investigators
- Nazeer Ahmed, MBBS, Principal investigator, Karachi medical and dental college karachi Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778889
- Sponsor's protocol ID
- KMDC-PA-MH-2025
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impacts of Physical Activity on Mental Health and Perceived Stress Among Undergraduate Medical Students in Pakistan: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06778889
- Acronym / sponsor ID
- KMDC-PA-MH-2025
- Conditions
- Mental Health, Perceived Stress, Physical Activity
- Keywords
- Mental Health profile, Perceived Stress, Medical students, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
This observational, cross-sectional study investigates the relationship between physical activity and its effects on mental health and perceived stress among undergraduate medical students in Pakistan. The study aims to determine whether engaging in regular physical activity can improve psychological well-being and reduce perceived stress in this population, which is known to face significant academic and personal stressors during their medical education.
Study Objectives and Rationale
Medical students encounter a variety of stressors, including demanding coursework, clinical responsibilities, and personal challenges. This study aims to provide a quantitative assessment of how physical activity can mitigate these stressors and improve mental health outcomes. It hypothesizes that students engaging in higher levels of physical activity will exhibit better mental health and lower perceived stress.
Study Design and Methodology
Study Design:
Observational, cross-sectional study. Data collected at a single time point using validated self-reported questionnaires.
Study Setting:
The study was conducted in both public and private medical colleges across Pakistan, providing a diverse sample of participants.
Data Collection Tools:
International Physical Activity Questionnaire (IPAQ-7): Used to measure physical activity levels, categorized as low, moderate, or high based on MET-minutes per week. Perceived Stress Scale (PSS-10): Used to quantify perceived stress levels. Scores are categorized as low (0-13), moderate (14-26), and high (27-40). Brief Symptom Inventory (BSI-18): Measures psychological distress, including somatization, depression, and anxiety, with a composite Global Severity Index (GSI).
Data Collection Procedure:
Participants were invited to complete online surveys distributed via Google Forms. Data collected included demographic information, physical activity habits (frequency, intensity, duration), stress levels, and mental health status. All participants provided informed consent, and confidentiality was maintained throughout the study.
Data Analysis Plan:
Descriptive statistics: Used to summarize participant demographics, activity levels, and mental health profiles. Inferential statistics: Chi-square tests to assess associations between physical activity levels and stress/mental health outcomes. Regression analysis to examine the predictive role of physical activity on mental health and perceived stress, adjusting for confounding factors such as age, gender, and academic year.
Study Duration:
The study was conducted over six months, with data collection completed within this timeframe. Key Technical Considerations The IPAQ-7 questionnaire quantifies physical activity in MET-minutes per week, allowing categorization into low (<600 MET-minutes/week), moderate (600-3000 MET-minutes/week), and high (>3000 MET-minutes/week) activity levels. The BSI-18 generates individual scores for somatization, depression, and anxiety, and calculates a composite GSI score (range: 0-72), where higher scores indicate greater psychological distress. Statistical analysis will control for potential confounders, ensuring robust interpretation of results. Significance and Potential Impact
This study will provide evidence on how physical activity can improve mental health and reduce stress among medical students in Pakistan, a population particularly vulnerable to mental health challenges. Findings may inform the development of interventions and institutional policies that integrate physical activity into student support systems to promote psychological well-being and academic success.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergraduate Medical Students | – | Behavioral: Undergraduate Medical StudentsThis 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Undergraduate Medical StudentsThis 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. | Behavioural | Undergraduate Medical Students |
Primary outcome
Mental Health Status of Undergraduate Medical Students
Time frame: Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.
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.
1 secondary outcome
Perceived Stress Levels among Undergraduate Medical Students.
Time frame: Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazeer Ahmed, MBBS principal investigator
Karachi medical and dental college karachi Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Perceived Stress, run by Rawalpindi Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Status of Undergraduate Medical Students (time frame: Data have been collected once during the survey period, which spans from February 2 to October 2, 2024.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.