- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451145
Stress Reduction Program for Iraqi Medical Students (SRIMS)
February 27, 2026 updated by: Adel Gassab Mohammed, University of Thi-Qar
Effects of Stress Reduction Intervention on Psychological, Cardiovascular, and Neuroendocrine Outcomes in Iraqi Medical Students During Examinations
A 4-week stress reduction program for medical students during exams, measuring effects on stress, heart rate, blood pressure, and stress hormones (ACTH, cortisol, DHEA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This single-group pre-post intervention study evaluates the effects of a culturally adapted 4-week stress-reduction program on psychological well-being, cardiovascular function, and hypothalamic-pituitary-adrenal (HPA) axis hormones in Iraqi medical students during examinations.
A total of 135 medical students participated in an 8-session mindfulness-based stress management program.
Primary outcomes included perceived stress (0-10 visual analog scale), heart rate, blood pressure, and serum levels of ACTH, cortisol, and DHEA, measured before and after the intervention.
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Thi-Qar
-
Nasiriyah, Thi-Qar, Iraq, 64001
- University of Thi-Qar College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- - Medical students at University of Thi-Qar College of Medicine
- Currently enrolled and preparing for examinations
- Age 18 years or older
- Willing to participate in 8 intervention sessions
- Able to provide informed consent
Exclusion Criteria:
Current use of medications affecting HPA axis or cardiovascular function
- Diagnosed chronic medical or psychiatric conditions
- Pregnancy or lactation
- Previous participation in formal mindfulness or stress management training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stress Reduction Intervention
All 135 participants receive a 4-week mindfulness-based stress reduction program consisting of 8 group sessions (90 minutes each, twice weekly) plus daily home practice (15-20 minutes).
Measurements taken at baseline and 4 weeks.
|
Culturally adapted 4-week stress reduction program including:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Score
Time Frame: Baseline and 4 weeks
|
Perceived Stress Score (0-10 visual analog scale)
|
Baseline and 4 weeks
|
|
ACTH Levels
Time Frame: Baseline and 4 weeks
|
Measure: Levels (pg/mL)
|
Baseline and 4 weeks
|
|
Cortisol Levels
Time Frame: Baseline and 4 weeks
|
Measure: Cortisol Levels (µg/dL)
|
Baseline and 4 weeks
|
|
DHEA Levels
Time Frame: Baseline and 4 weeks
|
Measure: DHEA Levels (ng/mL)
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Baseline and 4 weeks
|
Measure: Heart Rate (bpm)
|
Baseline and 4 weeks
|
|
Blood Pressure
Time Frame: Baseline and 4 weeks
|
Measure: Blood Pressure (mmHg) - Systolic and Diastolic
|
Baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Actual)
January 1, 2025
Study Completion (Actual)
January 1, 2025
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
February 27, 2026
First Posted (Actual)
March 5, 2026
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
February 27, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IQ. UTQ. MED. 2025. 0081
- Ethics approval IQ. UTQ. MED. (Other Identifier: University of Thi-Qar College of Medicine Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data collected for all primary and secondary outcome measures, including perceived stress scores, heart rate, blood pressure, and serum hormone levels (ACTH, cortisol, DHEA), along with demographic variables (age, sex) and intervention attendance data.
IPD Sharing Time Frame
Beginning 6 months and ending 5 years following article publication
IPD Sharing Access Criteria
Requests directed to adelgassab@utq.edu.iq.
Requestors must provide methodologically sound proposal and sign data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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