Health Belief Model-Based Vulvar Self-Examination Education

June 1, 2026 updated by: Ozge AYDOGAN ASIR, Eskisehir Osmangazi University

Effectiveness of a Health Belief Model-Based Vulvar Self-Examination Education Program on Women's Health Beliefs and Awareness: A Randomized Controlled Trial

This randomized controlled trial was conducted to evaluate the effectiveness of a Health Belief Model-based Vulvar Self-Examination (VSE) education program on women's health beliefs, vulvar health awareness, and vulvar self-examination behaviors. Vulvar diseases and symptoms are often overlooked due to insufficient awareness, stigma, and limited knowledge regarding vulvar health. Early recognition of vulvar symptoms may contribute to timely diagnosis and treatment of vulvar disorders.

Participants in the intervention group received a structured Health Belief Model-based education program on vulvar self-examination, while the control group received routine information. Data were collected using participant information forms, vulvar health awareness assessments, and Health Belief Model-based scales before and after the intervention.

The primary aim of the study was to improve women's awareness and health beliefs regarding vulvar self-examination. Secondary outcomes included changes in vulvar self-examination practices and vulvar health literacy. The findings of this study are expected to contribute to preventive women's health practices and early recognition of vulvar health problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted as a randomized controlled experimental trial to evaluate the effectiveness of a Health Belief Model-based Vulvar Self-Examination (VSE) education program among women. Vulvar diseases are common conditions affecting women's health; however, awareness regarding vulvar health and self-examination practices remains limited. Delayed recognition of vulvar symptoms may negatively affect early diagnosis and timely treatment of vulvar disorders.

The educational intervention was developed based on the constructs of the Health Belief Model, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. The intervention aimed to improve women's awareness, knowledge, and preventive health behaviors related to vulvar health and vulvar self-examination.

Participants were randomly assigned to either the intervention or control group. Women in the intervention group received a structured education program including information about vulvar anatomy, vulvar symptoms, vulvar hygiene, warning signs requiring medical evaluation, and the steps of vulvar self-examination. Educational materials included visual and written content designed to enhance self-efficacy and promote regular self-examination behavior. The control group received routine health information.

Data were collected before and after the intervention using participant information forms, vulvar health awareness assessments, and Health Belief Model-based scales. The primary outcome of the study was improvement in women's health beliefs and awareness regarding vulvar self-examination. Secondary outcomes included changes in vulvar self-examination practices and vulvar health literacy levels.

The findings of this study are expected to contribute to preventive women's health services by supporting early recognition of vulvar health problems and improving women's self-care behaviors related to vulvar health.

Study Type

Interventional

Enrollment (Actual)

203

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

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye)
        • Ankara Medipol University

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:

  • Women aged 18 years and older
  • Not having received prior education on vulvar self-examination
  • Not having a diagnosis of vulvar cancer
  • Agreeing to participate in the study

Exclusion Criteria:

  • Having a known history of genital disease
  • Having visual or cognitive impairments that may prevent active participation in the educational intervention

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Examination of the Vulva Education Group
Participants in this group received education on self-examination of the vulva, including vulvar anatomy, vulvar symptoms, warning signs, guided practice, educational materials, and counseling support.
Behavioral: Self-Examination of the Vulva Education Program
Participants received education on self-examination of the vulva, including vulvar anatomy, vulvar symptoms, warning signs, guided practice, educational materials, reminder messages, and counseling support.
No Intervention: Routine Information Control Group
Participants in this group received routine health information only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Champion Health Belief Model Scale Score for Vulvar Self-Examination
Time Frame: Baseline and 4 weeks post-intervention
Change in women's health beliefs regarding self-examination of the vulva (SEV), assessed using the Champion Health Belief Model Scale adapted for SEV. The scale includes perceived susceptibility, perceived severity, perceived benefits, perceived barriers, and self-efficacy/confidence. Higher scores indicate stronger health beliefs regarding SEV.
Baseline and 4 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvar Health Awareness Score
Time Frame: Baseline and 4 weeks post-intervention
Change in vulvar health awareness, assessed using the Vulvar Health Awareness and Vulvar Health Literacy Form (VSF-VSOF), a researcher-developed instrument. Scores were measured at baseline and 4 weeks post-intervention; higher scores indicate greater vulvar health awareness.
Baseline and 4 weeks post-intervention
Vulvar Health Literacy Score
Time Frame: Baseline and 4 weeks post-intervention
Change in vulvar health literacy, assessed using the Vulvar Health Awareness and Vulvar Health Literacy Form (VSF-VSOF), a researcher-developed instrument. Scores were measured at baseline and 4 weeks post-intervention; higher scores indicate greater vulvar health literacy.
Baseline and 4 weeks post-intervention
Self-Examination of the Vulva (SEV) Behavior
Time Frame: Baseline and 4 weeks post-intervention
Change in self-examination of the vulva (SEV) behavior, assessed using the SEV practice item of the Vulvar Health Awareness and Vulvar Health Literacy Form (VSF-VSOF). Measurements were obtained at baseline and 4 weeks post-intervention; higher scores indicate greater engagement in SEV behavior.
Baseline and 4 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Özge A Aydoğan Aşır, RN, PhD, Ankara Medipol University
  • Principal Investigator: Özge A Aşır Aşır, RN, PhD, Ankara Medipol University

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)

August 4, 2025

Primary Completion (Actual)

September 9, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKVM-RCT-2026-01
  • E-85859696-604.01.01-4661 (Other Identifier: Ankara Medipol University Non-Interventional Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and confidentiality considerations related to sensitive women's health information.

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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