NCT07789626

Brief Summary

This study aims to examine the effect of peer education based on the Health Belief Model (HBM) on university students' coping skills with premenstrual syndrome (PMS). PMS is a common health problem that lowers women's quality of life and negatively affects their social and academic performance. The study will be conducted with 56 female students studying at Istanbul Atlas University, utilizing a randomized controlled design. Following the administration of a pre-test, participants diagnosed with PMS will be randomly assigned to either the intervention or control groups. The intervention group will be taught strategies for coping with PMS symptoms through peer education, while the control group will only receive an educational brochure. The training sessions will be structured framework of the Health Belief Model and will cover topics such as the definition, causes, and risk factors of PMS, as well as healthy lifestyle habits (nutrition, exercise, stress management). Data will be collected using pre-test and post-test methods, and changes in PMS symptoms will be analyzed using SPSS software. The study is expected to increase students' awareness of PMS and strengthen their ability to cope with symptoms as a result of peer education. The study duration is planned for 12 months and is projected to be conducted between 2025 and 2026. The intervention group will receive peer education based on the Health Belief Model framework covering topics such as the causes, symptoms, and risk factors of PMS. The training will be delivered in a classroom setting as two sessions conducted biweekly. Lecture, group discussions, and audiovisual materials will be used as educational methods. Personal Information Form and the Premenstrual Syndrome Scale will be used as data collection tools. The scale will be first administered in the pre-test to evaluate the severity of the participants' PMS symptoms. Following random assignment, the scale will be administered three times prior to three menstrual cycles for both intervention and control groups. The obtained data will be analyzed using SPSS software, and differences between groups will be evaluated using independent samples t-test and analysis of variance (ANOVA). The statistical significance level will be accepted as p\<0.05. The findings to be obtained from this study are expected to demonstrate the potential of the peer education method to increase PMS awareness and strengthen coping skills with symptoms. The results of the research aim to contribute to the development of health education programs targeted toward university students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

peer educationhealth belief modelPremenstrual Syndrome (PMS)women's health

Outcome Measures

Primary Outcomes (1)

  • Change in Premenstrual Syndrome Severity

    Evaluated using the Premenstrual Syndrome Scale (PMSS) to assess the severity of participants' PMS symptoms across different dimensions. The scale will be administered a total of four times: at baseline (pre-test) and prior to three consecutive menstrual cycles (post-tests) to observe changes over time. Higher scores on the scale indicate a higher severity of premenstrual syndrome symptoms.

    Baseline (pre-test) and monthly prior to three consecutive menstrual cycles (over a period of 3 months post-intervention)

Study Arms (2)

Control Group

NO INTERVENTION

Participants in this arm will not receive any peer education sessions. They will only be provided with an educational brochure containing standard information about premenstrual syndrome (PMS) and its management.

Peer Education Group

EXPERIMENTAL

Participants in this arm will receive Health Belief Model (HBM)-based peer education regarding premenstrual syndrome (PMS). The training consists of two biweekly sessions delivered in a classroom setting, covering PMS definition, causes, risk factors, and healthy lifestyle habits (nutrition, exercise, stress management).

Behavioral: Peer Education Group

Interventions

Participants in this arm will receive Health Belief Model (HBM)-based peer education regarding premenstrual syndrome (PMS). The training consists of two biweekly sessions delivered in a classroom setting, covering PMS definition, causes, risk factors, and healthy lifestyle habits (nutrition, exercise, stress management).

Peer Education Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female university students who are diagnosed with or experience premenstrual syndrome (PMS) are eligible to participate in this study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a female university student studying at Istanbul Atlas University. Being diagnosed with or experiencing premenstrual syndrome (PMS) according to the Premenstrual Syndrome Scale pre-test baseline score.
  • Volunteering to participate in the study and providing written informed consent.
  • Having regular menstrual cycles.

You may not qualify if:

  • Not experiencing premenstrual syndrome (PMS) based on the pre-test screening. Having a diagnosed chronic gynecological, endocrine, or psychiatric disorder that could interfere with menstrual symptoms.
  • Being pregnant or breastfeeding. Using hormonal contraceptives or receiving hormonal therapy within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas university

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study is designed as a parallel-group, randomized controlled trial consisting of two arms: an intervention group and a control group. Following the pre-test, eligible female university students with premenstrual syndrome (PMS) will be randomly assigned to one of these two parallel arms. The intervention group will receive Health Belief Model-Based peer education delivered in two sessions biweekly within a classroom setting. The control group will only receive an educational brochure on PMS. Both groups will be monitored and evaluated over three consecutive menstrual cycles.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

January 12, 2026

Primary Completion

May 23, 2026

Study Completion

June 28, 2026

Last Updated

August 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the future publication of this study will be made available to qualified researchers. Data will be shared strictly for academic research purposes and systematic reviews to ensure transparency. Requests should be directed to the corresponding investigator via email, accompanied by a sound research proposal.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations