Vulva CancerNCT07159958
Simulation Supported Vulva Cancer and Self-Examination on Knowledge, Skills and Attitude
A study testing Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training in people with Vulva Cancer and Nurse Role, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to examine the effect of simulation-assisted vulvar cancer and vulva self-examination training on knowledge, skills and attitudes towards clinical practices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vulva Cancer, Nurse Role
- What is being tested?
- Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 5 Sep 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Able to read and write Turkish,
- Has not taken a course/seminar on vulvar cancer and self-vulvar examination,
- Enrolled in the Nursing Department of the Faculty of Health Sciences at Bartın University,
- Receiving education during the time period when the study is conducted,
- Volunteering to participate in the study.
Who cannot join
- Those who withdrew or dropped out of the study early,
- Those who were not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation Supported Vulva Cancer and Vulva Self-Examination Training on Knowledge, Skills and Attitude Towards Clinical Practices: A Randomized Controlled Study
Objective: The aim of this study was to examine the effect of simulation-assisted vulvar cancer and vulva self-examination training on knowledge, skills and attitudes towards clinical practices.
- Conditions
- Vulva Cancer, Nurse Role
- Being tested
- Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training
- Keywords
- Simulation Supported Education, Vulva Self-Examination, Attitude Towards Clinical Practices
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based Vulvar Cancer and Self-Vulvar Examination TrainingOther
The topics covered include the definition of vulvar cancer, risk factors, symptoms, preventive measures to protect against cancer, the definition of KKVM, and the steps involved in performing an examination. The inspection phase of the examination was demonstrated using a light source and mirror on a simulated model of the external genitalia. In addition, the topic was reiterated by explaining on the model how palpation examination is performed, when it should be performed, what signs and symptoms to look for, and in which cases a doctor should be consulted.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Not described Receives: Other: Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Vulva Examination Knowledge Level Form
The scale was developed by Karaman to assess knowledge and skills related to self-vulva examination. The KKVM Knowledge Form was created based on a review of studies in the field of vulvar cancer. It consists of 20 items for use in the form. The KKVM Knowledge Level Form consists of "Yes," "No," and "I don't know" options for participants to answer each item.
Measured: change from before implamentation patent and after 1st and 4th weeks of practice
Attitude Scale Toward Clinical Practice for Nursing Students
The scale consists of 26 items and 4 subscales (Beliefs and Expectations Regarding Clinical Practice, Positive Approach to Clinical Practice, Negative Approach to Clinical Practice, and Personal Development) and is a 5-point Likert scale. The first sub-dimension has eight items, the second sub-dimension has seven items, the third sub-dimension has seven items, and the fourth sub-dimension has four items.
Measured: change from before implamentation patent and after 1st and 4th weeks of practice
Self-Vulva Examination Skill Checklist Steps
Self-Vulva Examination Skill Checklist Steps
Measured: change from before implamentation patent and after 1st and 4th weeks of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start8 May 2025
- Primary completion30 May 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulva CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159958
- Sponsor's protocol ID
- 2025-SBB-0332
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation Supported Vulva Cancer and Vulva Self-Examination Training on Knowledge, Skills and Attitude Towards Clinical Practices: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07159958
- Acronym / sponsor ID
- 2025-SBB-0332
- Conditions
- Vulva Cancer, Nurse Role
- Keywords
- Simulation Supported Education, Vulva Self-Examination, Attitude Towards Clinical Practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 8 Sep 2025 (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.
Objective: The aim of this study was to examine the effect of simulation-assisted vulvar cancer and vulva self-examination training on knowledge, skills and attitudes towards clinical practices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older,
- Able to read and write Turkish,
- Has not taken a course/seminar on vulvar cancer and self-vulvar examination,
- Enrolled in the Nursing Department of the Faculty of Health Sciences at Bartın University,
- Receiving education during the time period when the study is conducted,
Key exclusion criteria (2 listed)
- Those who withdrew or dropped out of the study early,
- Those who were not willing to participate in the study.
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 |
|---|---|---|
| Simulation-Based Vulvar Cancer and Self-Vulvar Examination TrainingThe topics covered include the definition of vulvar cancer, risk factors, symptoms, preventive measures to protect against cancer, the definition of KKVM, and the steps involved in performing an examination. The inspection phase of the examination was demonstrated using a light source and mirror on a simulated model of the external genitalia. In addition, the topic was reiterated by explaining on the model how palpation examination is performed, when it should be performed, what signs and symptoms to look for, and in which cases a doctor should be consulted. | Other | Training group |
Primary outcome
Self-Vulva Examination Knowledge Level Form
Time frame: change from before implamentation patent and after 1st and 4th weeks of practice
The scale was developed by Karaman to assess knowledge and skills related to self-vulva examination. The KKVM Knowledge Form was created based on a review of studies in the field of vulvar cancer. It consists of 20 items for use in the form. The KKVM Knowledge Level Form consists of "Yes," "No," and "I don't know" options for participants to answer each item.
Attitude Scale Toward Clinical Practice for Nursing Students
Time frame: change from before implamentation patent and after 1st and 4th weeks of practice
The scale consists of 26 items and 4 subscales (Beliefs and Expectations Regarding Clinical Practice, Positive Approach to Clinical Practice, Negative Approach to Clinical Practice, and Personal Development) and is a 5-point Likert scale. The first sub-dimension has eight items, the second sub-dimension has seven items, the third sub-dimension has seven items, and the fourth sub-dimension has four items.
Self-Vulva Examination Skill Checklist Steps
Time frame: change from before implamentation patent and after 1st and 4th weeks of practice
Self-Vulva Examination Skill Checklist Steps
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 12 Sep 2025.
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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 Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training in people with Vulva Cancer and Nurse Role, run by Trakya 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 6 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 12 Sep 2025. 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?
Self-Vulva Examination Knowledge Level Form (time frame: change from before implamentation patent and after 1st and 4th weeks of practice). The study lists 3 primary outcomes in all. 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 12 Sep 2025.