NCT07451145

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

ACTHCortisolDHEAHPA axisStress reductionStress managementMindfulnessMedical studentsAcademic stressPsychological stressNeuroendocrineIraqExamination stressBehavioral interventionStress hormones

Outcome Measures

Primary Outcomes (4)

  • Perceived Stress Score

    Perceived Stress Score (0-10 visual analog scale)

    Baseline and 4 weeks

  • ACTH Levels

    Measure: Levels (pg/mL)

    Baseline and 4 weeks

  • Cortisol Levels

    Measure: Cortisol Levels (µg/dL)

    Baseline and 4 weeks

  • DHEA Levels

    Measure: DHEA Levels (ng/mL)

    Baseline and 4 weeks

Secondary Outcomes (2)

  • Heart Rate

    Baseline and 4 weeks

  • Blood Pressure

    Baseline and 4 weeks

Study Arms (1)

Stress Reduction Intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction Program

Interventions

Culturally adapted 4-week stress reduction program including: * 8 group sessions (2 per week, 90 minutes each) * Mindfulness meditation techniques * Progressive muscle relaxation * Breathing exercises * Psychoeducation about stress * Daily home practice (15-20 minutes) * Led by trained facilitators

Stress Reduction Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thi-Qar College of Medicine

Nasiriyah, Thi-Qar, 64001, Iraq

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-group pre-post intervention study. All 135 participants received an identical 8-session mindfulness-based stress reduction program delivered over 4 weeks. Outcome measures (stress, ACTH, cortisol, DHEA, heart rate, blood pressure) were assessed at baseline before the intervention and again at 4 weeks after program completion.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine and Endocrinology

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 5, 2026

Study Start

October 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 6 months and ending 5 years following article publication
Access Criteria
Requests directed to adelgassab@utq.edu.iq. Requestors must provide methodologically sound proposal and sign data access agreement.

Locations