NCT07159958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

22 days

First QC Date

August 30, 2025

Last Update Submit

September 6, 2025

Conditions

Keywords

Simulation Supported EducationVulva Self-ExaminationAttitude Towards Clinical Practices

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    change from before implamentation patent and after 1st and 4th weeks of practice

Study Arms (2)

Training group

EXPERIMENTAL
Other: Simulation-Based Vulvar Cancer and Self-Vulvar Examination Training

Control group

NO INTERVENTION

Interventions

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.

Training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who withdrew or dropped out of the study early,
  • Those who were not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

May 8, 2025

Primary Completion

May 30, 2025

Study Completion

September 5, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations