Health Belief Model-Based Vulvar Self-Examination Education

NCT07621315 | Completed

• 2 other identifiers: KKVM-RCT-2026-01E-85859696-604.01.01-4661
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vulvar Health; Vulvar Self-Examination; Women's Health; Health Belief Model

Keywords

Vulvar self-examination; Health Belief Model; Women's health; Vulvar awareness; Vulvar health literacy; Preventive health behavior; Health education; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Champion Health Belief Model Scale Score for Vulvar Self-Examination

  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 Outcomes (3)

• Vulvar Health Awareness Score

  Baseline and 4 weeks post-intervention

• Vulvar Health Literacy Score

  Baseline and 4 weeks post-intervention

• Self-Examination of the Vulva (SEV) Behavior

  Baseline and 4 weeks post-intervention

Study Arms (2)

Self-Examination of the Vulva Education Group

EXPERIMENTAL

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

Routine Information Control Group

NO INTERVENTION

Participants in this group received routine health information only.

Interventions

Self-Examination of the Vulva Education Program BEHAVIORAL

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.

Self-Examination of the Vulva Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Ankara Medipol University

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Özge A Aydoğan Aşır, RN, PhD

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

• Özge A Aşır Aşır, RN, PhD

  ANKARA MEDİPOL UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were not informed about group allocation during the study process. In addition, data entry and statistical analyses were conducted by an independent statistician using coded datasets to minimize assessment bias and maintain outcome assessor blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned to either the intervention group receiving a Health Belief Model-based vulvar self-examination education program or the control group receiving routine information. Outcomes were evaluated using a parallel-group pretest-posttest randomized controlled design.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 2, 2026
• Study Start: August 4, 2025
• Primary Completion: September 9, 2025
• Study Completion: October 10, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)