NCT07479459

Brief Summary

The goal of this clinical trial is to increase students' awareness about Self-Vulvar Examination (SVE), and to evaluate the effect of a peer education module and an educational brochure on students' knowledge and behaviors related to SVE. The main questions it aims to answer are:

  • Does providing peer education module and an educational brochure about SVE increase students' knowledge levels regarding SVE?
  • Does providing peer education module and an educational brochure about SVE increase students' behaviors of practice SVE? Researchers will compare the peer education module and educational brochure regarding KKVM with a control group to determine whether it has an impact on students' knowledge and behavior about KKVM. Students; After the pretest, they will learn about KKVM through a peer education module or educational brochure, or they will be in the control group. Three months later, a posttest will assess their knowledge and behaviors about KKVM.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress99%
Jan 2023Jun 2026

Study Start

First participant enrolled

January 15, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

November 17, 2025

Last Update Submit

March 14, 2026

Conditions

Keywords

Vulvar Self-ExaminationHealth EducationPeer Education ModelVulvar Health

Outcome Measures

Primary Outcomes (2)

  • VSE Behavior Determination Form

    This form consists of two questions prepared to determine the students' VSE (Vulvar Self-Examination) practices and their reasons for not performing it."

    Baseline, 3 months post-intervention

  • Vulvar Health and VSE Knowledge Form

    This form contains 16 questions aimed at determining the students' knowledge about vulvar health.

    Baseline, 3 months post-intervention

Secondary Outcomes (2)

  • VSE Behavior and Satisfaction with the Educational Brochure Form

    3 months post-intervention

  • Satisfaction with the Peer Education Module Form

    3 months post-intervention

Study Arms (3)

Intervention 1 ( Brochure Group)

EXPERIMENTAL

It consists of second-year nursing students. A brochure prepared about VSE (Vulvar Self-Examination) will be distributed to this group. Before the brochure is distributed, a pre-test, consisting of the Personal Information Form and the Vulvar Health and VSE Knowledge Form, will be administered. After the form application, the brochures will be distributed, and a 3-month follow-up will be conducted. At the end of the 3-month period, the VSE Knowledge Form and the VSE Behavior and Satisfaction with the Educational Brochure Form will be administered to the second-year students as a post-test.

Behavioral: Brochure

Intervention 2 (Peer Education Group)

EXPERIMENTAL

In the peer education module, first-year nursing students will be provided with a 35-minute presentation, which we prepared, on Vulvar Health and VSE (Vulvar Self-Examination). Following the training, the 'Satisfaction with the Peer Education Module Form' will be administered to the students. The Intervention 2 group will also have a 3-month follow-up period. At the end of the 3 months, the 'Vulvar Health and VSE Knowledge Form' and the 'VSE Behavior Determination Form' will be transmitted online as a post-test, and the post-test data will be collected.

Behavioral: Peer Education

Control Group

ACTIVE COMPARATOR

Preparatory students were randomly selected as the control group. The pre-tests were sent to the preparatory students online. As a post-test, the 'Vulvar Health and VSE (Vulvar Self-Examination) Knowledge Form' and the 'VSE Behavior Determination Form' will be administered online at the end of the 3-month follow-up period.

Other: Control

Interventions

BrochureBEHAVIORAL

A brochure about the Vulvar Self-Examination (VSE) will be distributed to this group, and a three-month follow-up will be conducted. At the end of the three-month period, a posttest will be administered to second-year students to measure changes in knowledge and behavior.

Intervention 1 ( Brochure Group)
Peer EducationBEHAVIORAL

Following the peer education, students will also have a 3-month follow-up period. At the end of the 3 months, the post-test data will be collected o measure changes in knowledge and behavior.

Intervention 2 (Peer Education Group)
ControlOTHER

The pre-tests were sent to the control group. As a post-test, will be administered online at the end of the 3-month follow-up period.

Control Group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being a female student in the Yeditepe University Faculty of Health Sciences, Department of Nursing
  • Not having had a previous vulvar mass or cancer
  • Not having any communication barriers
  • Being able to read and understand Turkish
  • Having a mobile phone with internet access.

You may not qualify if:

  • Not being a female student in the Yeditepe University Faculty of Health Sciences Nursing Department
  • Having previously had a vulvar mass or cancer
  • Having any communication barriers
  • Not being able to read or understand Turkish
  • Not having a mobile phone with internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Bevilacqua F, Selk A, Stockdale C, Vieira-Baptista P, Adedipe T, Bohl T, Marozio L, Borella F, Gallio N, Pollano B, Robba E, Barbierato I, Benedetto C, Preti M. The International Society for the Study of Vulvovaginal Disease (ISSVD) Vulvar Awareness Day Campaign: Knowledge of Vulvovaginal Diseases Among Italian Obstetrics and Gynecology Residents. J Low Genit Tract Dis. 2024 Jan 1;28(1):91-94. doi: 10.1097/LGT.0000000000000777. Epub 2023 Nov 8.

    PMID: 37906606BACKGROUND
  • Selk A, Elangainesan P, Tannenbaum E, Wong K. "Check Your Vulva"-A Patient Education and Virtual Vulva Care Pilot Project. J Low Genit Tract Dis. 2023 Oct 1;27(4):390-394. doi: 10.1097/LGT.0000000000000770.

    PMID: 37729049BACKGROUND
  • Dundar T, Aksu H, Gercek Oter E, Toptas Acar B, Ozsoy S. Development and Effectiveness of a Mobile Application for Vulvar Self-examination: A Quasi-Experimental Study. J Low Genit Tract Dis. 2024 Oct 1;28(4):365-370. doi: 10.1097/LGT.0000000000000835.

    PMID: 40411888BACKGROUND
  • Muigai J, Jacob L, Dinas K, Kostev K, Kalder M. Potential delay in the diagnosis of vulvar cancer and associated risk factors in women treated in German gynecological practices. Oncotarget. 2018 Jan 3;9(9):8725-8730. doi: 10.18632/oncotarget.23848. eCollection 2018 Feb 2.

    PMID: 29492231BACKGROUND

MeSH Terms

Conditions

Vulvar DiseasesHealth Education

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

March 18, 2026

Study Start

January 15, 2023

Primary Completion

January 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations