Premenstrual Syndrome-PMSHBM-PEPSNCT07789626
Effect of Health Belief Model-Based Peer Education on Premenstrual Syndrome
A study testing Peer Education Group in people with Premenstrual Syndrome-PMS, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome-PMS
- What is being tested?
- Peer Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2026to 28 Jun 2026
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Health Belief Model-Based Peer Education on University Students' Coping With Premenstrual Syndrome: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Premenstrual Syndrome-PMS
- Being tested
- Peer Education Group
- Keywords
- peer education, health belief model, Premenstrual Syndrome (PMS), women's health
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Education GroupBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Peer Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-test) and monthly prior to three consecutive menstrual cycles (over a period of 3 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start12 Jan 2026
- Primary completion23 May 2026
- Study completion28 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Syndrome-PMSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlas University
- Responsible party
- Principal investigator, Sehma Aydin Sen, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789626
- Sponsor's protocol ID
- E-22686390-050.99-56873
- Other IDs
- 1919B012470238
- Acronym
- HBM-PEPS
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Belief Model-Based Peer Education on University Students' Coping With Premenstrual Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07789626
- Acronym / sponsor ID
- HBM-PEPS / E-22686390-050.99-56873
- Conditions
- Premenstrual Syndrome-PMS
- Keywords
- peer education, health belief model, Premenstrual Syndrome (PMS), women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Atlas University
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 28 Jun 2026 (actual)
- First posted
- 27 Aug 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Peer Education GroupParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Peer Education GroupParticipants 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). | Behavioural | Peer Education Group |
Primary outcome
Change in Premenstrual Syndrome Severity
Time frame: Baseline (pre-test) and monthly prior to three consecutive menstrual cycles (over a period of 3 months post-intervention)
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.
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Education Group in people with Premenstrual Syndrome-PMS, run by Koç University at 1 site in Turkey (Türkiye).
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 2 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 27 Aug 2026. 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 Turkey (Türkiye). 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?
Change in Premenstrual Syndrome Severity (time frame: Baseline (pre-test) and monthly prior to three consecutive menstrual cycles (over a period of 3 months post-intervention)). 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 27 Aug 2026.