Vulvar Self-ExaminationSVENCT07479459
Different Education Methods and Self Vulvar Examination (SVE)
A study testing Brochure and Peer Education in people with Vulvar Self-Examination and Health Knowledge,Practices,Attitudes, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to increase students' awareness about Self-Vulvar Examination (SVE), and to evaluate the effect of a peer education module and an educational brochure on students' knowledge and behaviors related to SVE. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Self-Examination, Health Knowledge,Practices,Attitudes, Vulva Disease
- What is being tested?
- Brochure and Peer Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Being a female student in the Yeditepe University Faculty of Health Sciences, Department of Nursing
- Not having had a previous vulvar mass or cancer
- Not having any communication barriers
- Being able to read and understand Turkish
- Having a mobile phone with internet access.
Who cannot join
- • Not being a female student in the Yeditepe University Faculty of Health Sciences Nursing Department
- Having previously had a vulvar mass or cancer
- Having any communication barriers
- Not being able to read or understand Turkish
- Not having a mobile phone with internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Different Education Methods on Vulva Self-Examination on the Knowledge and Behaviors of University Students About Self Vulvar Examination: A Randomized Controlled Trial
The goal of this clinical trial is to increase students' awareness about Self-Vulvar Examination (SVE), and to evaluate the effect of a peer education module and an educational brochure on students' knowledge and behaviors related to SVE.
The main questions it aims to answer are:
Read more
- Does providing peer education module and an educational brochure about SVE increase students' knowledge levels regarding SVE?
- Does providing peer education module and an educational brochure about SVE increase students' behaviors of practice SVE? Researchers will compare the peer education module and educational brochure regarding KKVM with a control group to determine whether it has an impact on students' knowledge and behavior about KKVM.
Students; After the pretest, they will learn about KKVM through a peer education module or educational brochure, or they will be in the control group.
Three months later, a posttest will assess their knowledge and behaviors about KKVM.
Read the detailed description
Providing self vulvar examination (VSE) education to women enables them to take an active role in monitoring their own health, facilitates the early detection of potential abnormalities, and ensures timely intervention and management. Furthermore, providing VSE education to women at a young age plays a critical role in developing early awareness and establishing VSE, which is a protective health behavior, as a habit. In recent years, one of the methods used within the scope of health education is the 'peer education model,' which is one of the 'models centered on social interaction,' where students work in a way that supports each other's learning. Therefore, this study aims to determine the effect of peer education and an educational brochure about VSE on the knowledge and behaviors of university students regarding VSE The sample of the research; It is planned to consist of a total of 105 student, 35 in the Peer Education Group, 35 in the Brochure Group and 35 in the Control Group, who meet the inclusion criteria and voluntarily agreed to participate in the research.
During the pre-test and post-test data collection phase, it is planned to use, 'Personal Information Form', 'Vulva Health and SVE Information Form', 'SVE Behavior Determination Form', SVE Behavior Determination, Education Brochure Satisfaction Determination Form', 'Peer Education Module Satisfaction Determination Form' and 'SVE Behavior Determination Form'.
Intervention 1 (Brochure Group) consists of second-year nursing students. A brochure prepared about VSE will be distributed to this group. Before the brochure is distributed, a pre-test, consisting of the Personal Information Form and the Vulvar Health and VSE Knowledge Form, will be administered. After the form pretest, the brochures will be distributed, and a 3-month follow-up will be conducted. At the end of the 3-month period, the VSE Knowledge Form and the VSE Behavior and Satisfaction with the Educational Brochure Form will be administered to the second-year students as a post-test. In the Intervention 2 (Peer Education Group) module, first-year nursing students will be provided with a 35-minute presentation on Vulvar Health and VSE (Vulvar Self-Examination). Following the training, the 'Satisfaction with the Peer Education Module Form' will be administered to the students. The Intervention 2 group will also have a 3-month follow-up period. At the end of the 3 months, the 'Vulvar Health and VSE Knowledge Form' and the 'VSE Behavior Determination Form' will be transmitted online as a post-test, and the post-test data will be collected. Preparatory students will be randomly assigned to the control group. The Personal Information Form and the Vulvar Health and VSE (Vulvar Self-Examination) Knowledge Form will be administered online to these students as a pre-test. As a post-test, the Vulvar Health and VSE Knowledge Form and the VSE Behavior Determination Form will be administered online at the end of the 3-month follow-up period.
- Being tested
- Brochure, Peer Education, Control
- Keywords
- Vulvar Self-Examination, Health Education, Peer Education Model, Vulvar Health
- Medical subject headings
- Vulvar Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrochureBehavioural
A brochure about the Vulvar Self-Examination (VSE) will be distributed to this group, and a three-month follow-up will be conducted. At the end of the three-month period, a posttest will be administered to second-year students to measure changes in knowledge and behavior.
Peer EducationBehavioural
Following the peer education, students will also have a 3-month follow-up period. At the end of the 3 months, the post-test data will be collected o measure changes in knowledge and behavior.
ControlOther
The pre-tests were sent to the control group. As a post-test, will be administered online at the end of the 3-month follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 ( Brochure Group) | Experimental | It consists of second-year nursing students. A brochure prepared about VSE (Vulvar Self-Examination) will be distributed to this group. Before the brochure is distributed, a pre-test, consisting of the Personal Information Form and the Vulvar Health and VSE Knowledge Form, will be administered. After the form application, the brochures will be distributed, and a 3-month follow-up will be conducted. At the end of the 3-month period, the VSE Knowledge Form and the VSE Behavior and Satisfaction with the Educational Brochure Form will be administered to the second-year students as a post-test. Receives: Behavioral: Brochure |
| Intervention 2 (Peer Education Group) | Experimental | In the peer education module, first-year nursing students will be provided with a 35-minute presentation, which we prepared, on Vulvar Health and VSE (Vulvar Self-Examination). Following the training, the 'Satisfaction with the Peer Education Module Form' will be administered to the students. The Intervention 2 group will also have a 3-month follow-up period. At the end of the 3 months, the 'Vulvar Health and VSE Knowledge Form' and the 'VSE Behavior Determination Form' will be transmitted online as a post-test, and the post-test data will be collected. Receives: Behavioral: Peer Education |
| Control Group | Active comparator | Preparatory students were randomly selected as the control group. The pre-tests were sent to the preparatory students online. As a post-test, the 'Vulvar Health and VSE (Vulvar Self-Examination) Knowledge Form' and the 'VSE Behavior Determination Form' will be administered online at the end of the 3-month follow-up period. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VSE Behavior Determination Form
This form consists of two questions prepared to determine the students' VSE (Vulvar Self-Examination) practices and their reasons for not performing it."
Measured: Baseline, 3 months post-intervention
Vulvar Health and VSE Knowledge Form
This form contains 16 questions aimed at determining the students' knowledge about vulvar health.
Measured: Baseline, 3 months post-intervention
Secondary outcomes (2)
VSE Behavior and Satisfaction with the Educational Brochure Form
This form consists of two questions aimed at assessing the students' satisfaction with the educational method used. Participants were asked to indicate their level of satisfaction with the brochure by marking on a Visual Analog Scale (VAS).
Measured: 3 months post-intervention
Satisfaction with the Peer Education Module Form
This form consists of three questions aimed at assessing the students' satisfaction with the educational method used. Participants were asked to indicate their level of satisfaction with the peer education by marking on a Visual Analog Scale (VAS).
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Jan 2023
- Primary completion30 Jan 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vulvar Self-ExaminationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479459
- Sponsor's protocol ID
- E-56365223-050.04-2025.137548.
- Acronym
- SVE
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bevilacqua F, Selk A, Stockdale C, Vieira-Baptista P, Adedipe T, Bohl T, Marozio L, Borella F, Gallio N, Pollano B, Robba E, Barbierato I, Benedetto C, Preti M. The International Society for the Study of Vulvovaginal Disease (ISSVD) Vulvar Awareness Day Campaign: Knowledge of Vulvovaginal Diseases Among Italian Obstetrics and Gynecology Residents. J Low Genit Tract Dis. 2024 Jan 1;28(1):91-94. doi: 10.1097/LGT.0000000000000777. Epub 2023 Nov 8.
PubMed 37906606Selk A, Elangainesan P, Tannenbaum E, Wong K. "Check Your Vulva"-A Patient Education and Virtual Vulva Care Pilot Project. J Low Genit Tract Dis. 2023 Oct 1;27(4):390-394. doi: 10.1097/LGT.0000000000000770.
PubMed 37729049Dundar T, Aksu H, Gercek Oter E, Toptas Acar B, Ozsoy S. Development and Effectiveness of a Mobile Application for Vulvar Self-examination: A Quasi-Experimental Study. J Low Genit Tract Dis. 2024 Oct 1;28(4):365-370. doi: 10.1097/LGT.0000000000000835.
PubMed 40411888Muigai J, Jacob L, Dinas K, Kostev K, Kalder M. Potential delay in the diagnosis of vulvar cancer and associated risk factors in women treated in German gynecological practices. Oncotarget. 2018 Jan 3;9(9):8725-8730. doi: 10.18632/oncotarget.23848. eCollection 2018 Feb 2.
PubMed 29492231
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Education Methods on Vulva Self-Examination on the Knowledge and Behaviors of University Students About Self Vulvar Examination: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07479459
- Acronym / sponsor ID
- SVE / E-56365223-050.04-2025.137548.
- Keywords
- Vulvar Self-Examination, Health Education, Peer Education Model, Vulvar Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Mar 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.
The goal of this clinical trial is to increase students' awareness about Self-Vulvar Examination (SVE), and to evaluate the effect of a peer education module and an educational brochure on students' knowledge and behaviors related to SVE.
The main questions it aims to answer are:
- Does providing peer education module and an educational brochure about SVE increase students' knowledge levels regarding SVE?
- Does providing peer education module and an educational brochure about SVE increase students' behaviors of practice SVE? Researchers will compare the peer education module and educational brochure regarding KKVM with a control group to determine whether it has an impact on students' knowledge and behavior about KKVM.
Students; After the pretest, they will learn about KKVM through a peer education module or educational brochure, or they will be in the control group.
Three months later, a posttest will assess their knowledge and behaviors about KKVM.
Detailed description
Providing self vulvar examination (VSE) education to women enables them to take an active role in monitoring their own health, facilitates the early detection of potential abnormalities, and ensures timely intervention and management. Furthermore, providing VSE education to women at a young age plays a critical role in developing early awareness and establishing VSE, which is a protective health behavior, as a habit. In recent years, one of the methods used within the scope of health education is the 'peer education model,' which is one of the 'models centered on social interaction,' where students work in a way that supports each other's learning. Therefore, this study aims to determine the effect of peer education and an educational brochure about VSE on the knowledge and behaviors of university students regarding VSE The sample of the research; It is planned to consist of a total of 105 student, 35 in the Peer Education Group, 35 in the Brochure Group and 35 in the Control Group, who meet the inclusion criteria and voluntarily agreed to participate in the research.
During the pre-test and post-test data collection phase, it is planned to use, 'Personal Information Form', 'Vulva Health and SVE Information Form', 'SVE Behavior Determination Form', SVE Behavior Determination, Education Brochure Satisfaction Determination Form', 'Peer Education Module Satisfaction Determination Form' and 'SVE Behavior Determination Form'.
Intervention 1 (Brochure Group) consists of second-year nursing students. A brochure prepared about VSE will be distributed to this group. Before the brochure is distributed, a pre-test, consisting of the Personal Information Form and the Vulvar Health and VSE Knowledge Form, will be administered. After the form pretest, the brochures will be distributed, and a 3-month follow-up will be conducted. At the end of the 3-month period, the VSE Knowledge Form and the VSE Behavior and Satisfaction with the Educational Brochure Form will be administered to the second-year students as a post-test. In the Intervention 2 (Peer Education Group) module, first-year nursing students will be provided with a 35-minute presentation on Vulvar Health and VSE (Vulvar Self-Examination). Following the training, the 'Satisfaction with the Peer Education Module Form' will be administered to the students. The Intervention 2 group will also have a 3-month follow-up period. At the end of the 3 months, the 'Vulvar Health and VSE Knowledge Form' and the 'VSE Behavior Determination Form' will be transmitted online as a post-test, and the post-test data will be collected. Preparatory students will be randomly assigned to the control group. The Personal Information Form and the Vulvar Health and VSE (Vulvar Self-Examination) Knowledge Form will be administered online to these students as a pre-test. As a post-test, the Vulvar Health and VSE Knowledge Form and the VSE Behavior Determination Form will be administered online at the end of the 3-month follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 ( Brochure Group) | Experimental | Behavioral: BrochureIt consists of second-year nursing students. A brochure prepared about VSE (Vulvar Self-Examination) will be distributed to this group. Before the brochure is distributed, a pre-test, consisting of the Personal Information Form and the Vulvar Health and VSE Knowledge Form, will be administered. After the form application, the brochures will be distributed, and a 3-month follow-up will be conducted. At the end of the 3-month period, the VSE Knowledge Form and the VSE Behavior and Satisfaction with the Educational Brochure Form will be administered to the second-year students as a post-test. |
| Intervention 2 (Peer Education Group) | Experimental | Behavioral: Peer EducationIn the peer education module, first-year nursing students will be provided with a 35-minute presentation, which we prepared, on Vulvar Health and VSE (Vulvar Self-Examination). Following the training, the 'Satisfaction with the Peer Education Module Form' will be administered to the students. The Intervention 2 group will also have a 3-month follow-up period. At the end of the 3 months, the 'Vulvar Health and VSE Knowledge Form' and the 'VSE Behavior Determination Form' will be transmitted online as a post-test, and the post-test data will be collected. |
| Control Group | Active comparator | Other: ControlPreparatory students were randomly selected as the control group. The pre-tests were sent to the preparatory students online. As a post-test, the 'Vulvar Health and VSE (Vulvar Self-Examination) Knowledge Form' and the 'VSE Behavior Determination Form' will be administered online at the end of the 3-month follow-up period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • Being a female student in the Yeditepe University Faculty of Health Sciences, Department of Nursing
Key exclusion criteria (5 listed)
- • Not being a female student in the Yeditepe University Faculty of Health Sciences Nursing Department
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 |
|---|---|---|
| BrochureA brochure about the Vulvar Self-Examination (VSE) will be distributed to this group, and a three-month follow-up will be conducted. At the end of the three-month period, a posttest will be administered to second-year students to measure changes in knowledge and behavior. | Behavioural | Intervention 1 ( Brochure Group) |
| Peer EducationFollowing the peer education, students will also have a 3-month follow-up period. At the end of the 3 months, the post-test data will be collected o measure changes in knowledge and behavior. | Behavioural | Intervention 2 (Peer Education Group) |
| ControlThe pre-tests were sent to the control group. As a post-test, will be administered online at the end of the 3-month follow-up period. | Other | Control Group |
Primary outcome
VSE Behavior Determination Form
Time frame: Baseline, 3 months post-intervention
This form consists of two questions prepared to determine the students' VSE (Vulvar Self-Examination) practices and their reasons for not performing it."
Vulvar Health and VSE Knowledge Form
Time frame: Baseline, 3 months post-intervention
This form contains 16 questions aimed at determining the students' knowledge about vulvar health.
2 secondary outcomes
VSE Behavior and Satisfaction with the Educational Brochure Form
Time frame: 3 months post-intervention
Satisfaction with the Peer Education Module Form
Time frame: 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 37906606Bevilacqua F, Selk A, Stockdale C, Vieira-Baptista P, Adedipe T, Bohl T, Marozio L, Borella F, Gallio N, Pollano B, Robba E, Barbierato I, Benedetto C, Preti M. The International Society for the Study of Vulvovaginal Disease (ISSVD) Vulvar Awareness Day Campaign: Knowledge of Vulvovaginal Diseases Among Italian Obstetrics and Gynecology Residents. J Low Genit Tract Dis. 2024 Jan 1;28(1):91-94. doi: 10.1097/LGT.0000000000000777. Epub 2023 Nov 8.
- Background: PubMed 37729049Selk A, Elangainesan P, Tannenbaum E, Wong K. "Check Your Vulva"-A Patient Education and Virtual Vulva Care Pilot Project. J Low Genit Tract Dis. 2023 Oct 1;27(4):390-394. doi: 10.1097/LGT.0000000000000770.
- Background: PubMed 40411888Dundar T, Aksu H, Gercek Oter E, Toptas Acar B, Ozsoy S. Development and Effectiveness of a Mobile Application for Vulvar Self-examination: A Quasi-Experimental Study. J Low Genit Tract Dis. 2024 Oct 1;28(4):365-370. doi: 10.1097/LGT.0000000000000835.
- Background: PubMed 29492231Muigai J, Jacob L, Dinas K, Kostev K, Kalder M. Potential delay in the diagnosis of vulvar cancer and associated risk factors in women treated in German gynecological practices. Oncotarget. 2018 Jan 3;9(9):8725-8730. doi: 10.18632/oncotarget.23848. eCollection 2018 Feb 2.
- Individual participant dataSharing planned: No
Related trials for Vulvar Self-Examination
Not yet recruiting
CPP Among Somali Women in Norway: SCED
Chronic Pelvic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brochure and Peer Education in people with Vulvar Self-Examination and Health Knowledge,Practices,Attitudes, run by Yeditepe 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
VSE Behavior Determination Form (time frame: Baseline, 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07479459, which also lists 4 linked publications.
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 18 Mar 2026.