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| ID | Type | Description | Link |
|---|---|---|---|
| E-85859696-604.01.01-4661 | Other Identifier | Ankara Medipol University Non-Interventional Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Routine Information Control Group | No Intervention | Participants in this group received routine health information only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vulvar Health Awareness Score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Özge A Aydoğan Aşır, RN, PhD | Ankara Medipol University | Principal Investigator |
| Özge A Aşır Aşır, RN, PhD | ANKARA MEDİPOL UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Medipol University | Ankara | Ankara | Turkey (Türkiye) |
Individual participant data will not be shared due to privacy and confidentiality considerations related to sensitive women's health information.
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| ID | Term |
|---|---|
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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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.
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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.
| Vulvar Health Literacy Score | 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 | 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 |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |