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Health Belief Model-Based Vulvar Self-Examination Education

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07621315
Enrollment
203
Registered
2026-06-02
Start date
2025-08-04
Completion date
2025-10-10
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

BEHAVIORALSelf-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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Champion Health Belief Model Scale Score for Vulvar Self-ExaminationBaseline and 4 weeks post-interventionChange 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

MeasureTime frameDescription
Vulvar Health Awareness ScoreBaseline and 4 weeks post-interventionChange 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.
Vulvar Health Literacy ScoreBaseline and 4 weeks post-interventionChange 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.
Self-Examination of the Vulva (SEV) BehaviorBaseline and 4 weeks post-interventionChange 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORÖzge A Aydoğan Aşır, RN, PhD

Ankara Medipol University

PRINCIPAL_INVESTIGATORÖzge A Aşır Aşır, RN, PhD

ANKARA MEDİPOL UNIVERSITY

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026