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Completed

NCT Number: NCT07621315

Health Belief Model-Based Vulvar Self-Examination Education

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.

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Key information

Conditions

Vulvar Health Adherence Interventions Behavior Health Behavior Health Belief Model Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vulvar Self-Examination Women's Health

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Medipol University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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