Vulvar HealthNCT07621315
Health Belief Model-Based Vulvar Self-Examination Education
A study testing Self-Examination of the Vulva Education Program in people with Vulvar Health and Vulvar Self-Examination, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Health, Vulvar Self-Examination, Women's Health
- What is being tested?
- Self-Examination of the Vulva Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having a known history of genital disease
- Having visual or cognitive impairments that may prevent active participation in the educational intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Self-Examination of the Vulva Education Program
- Keywords
- Vulvar self-examination, Health Belief Model, Women's health, Vulvar awareness, Vulvar health literacy, Preventive health behavior, Health education, Randomized controlled trial
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Examination of the Vulva Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Examination of the Vulva Education Program |
| Routine Information Control Group | No intervention | Participants in this group received routine health information only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks post-intervention
Secondary outcomes (3)
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.
Measured: Baseline and 4 weeks post-intervention
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.
Measured: 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.
Measured: Baseline and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start4 Aug 2025
- Primary completion9 Sep 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge AYDOGAN ASIR, Ankara Medipol University
- Investigators
- Özge A Aydoğan Aşır, RN, PhD, Principal investigator, Ankara Medipol UniversityÖzge A Aşır Aşır, RN, PhD, Principal investigator, ANKARA MEDİPOL UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621315
- Sponsor's protocol ID
- KKVM-RCT-2026-01
- Other IDs
- E-85859696-604.01.01-4661
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations related to sensitive women's health information.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Health Belief Model-Based Vulvar Self-Examination Education Program on Women's Health Beliefs and Awareness: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07621315
- Acronym / sponsor ID
- KKVM-RCT-2026-01
- Keywords
- Vulvar self-examination, Health Belief Model, Women's health, Vulvar awareness, Vulvar health literacy, Preventive health behavior, Health education, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-Examination of the Vulva Education Group | Experimental | Behavioral: Self-Examination of the Vulva Education ProgramParticipants 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. |
| Routine Information Control Group | No intervention | –Participants in this group received routine health information only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Having a known history of genital disease
- Having visual or cognitive impairments that may prevent active participation in the educational intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Examination of the Vulva Education ProgramParticipants received education on self-examination of the vulva, including vulvar anatomy, vulvar symptoms, warning signs, guided practice, educational materials, reminder messages, and counseling support. | Behavioural | Self-Examination of the Vulva Education Group |
Primary outcome
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.
3 secondary outcomes
Vulvar Health Awareness Score
Time frame: Baseline and 4 weeks post-intervention
Vulvar Health Literacy Score
Time frame: Baseline and 4 weeks post-intervention
Self-Examination of the Vulva (SEV) Behavior
Time frame: Baseline and 4 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations related to sensitive women's health information.
Related trials for Vulvar Health
Active, not recruiting
e-Health Intervention (Day-by-Day) for the Management of Fear of Progression in Women With Stage III or IV Gynecologic Cancer: A Pilot Study
Malignant Female Reproductive System Neoplasm, Stage III Cervical Cancer AJCC v8
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Not yet recruiting
CPP Among Somali Women in Norway: SCED
Chronic Pelvic Pain
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özge A Aydoğan Aşır, RN, PhD principal investigator
Ankara Medipol University
Özge A Aşır Aşır, RN, PhD principal investigator
ANKARA MEDİPOL UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Examination of the Vulva Education Program in people with Vulvar Health and Vulvar Self-Examination, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Champion Health Belief Model Scale Score for Vulvar Self-Examination (time frame: Baseline and 4 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.