Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:55 AM
Study NCT ID:
NCT07479459
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Education Methods and Self Vulvar Examination (SVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VSE Behavior Determination Form', 'timeFrame': 'Baseline, 3 months post-intervention', 'description': 'This form consists of two questions prepared to determine the students\' VSE (Vulvar Self-Examination) practices and their reasons for not performing it."'}, {'measure': 'Vulvar Health and VSE Knowledge Form', 'timeFrame': 'Baseline, 3 months post-intervention', 'description': "This form contains 16 questions aimed at determining the students' knowledge about vulvar health."}], 'secondaryOutcomes': [{'measure': 'VSE Behavior and Satisfaction with the Educational Brochure Form', 'timeFrame': '3 months post-intervention', 'description': "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)."}, {'measure': 'Satisfaction with the Peer Education Module Form', 'timeFrame': '3 months post-intervention', 'description': "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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vulvar Self-Examination', 'Health Education', 'Peer Education Model', 'Vulvar Health'], 'conditions': ['Vulvar Self-Examination', 'Health Knowledge,Practices,Attitudes', 'Vulva Disease']}, 'referencesModule': {'references': [{'pmid': '37906606', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37729049', 'type': 'BACKGROUND', 'citation': 'Selk 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.'}, {'pmid': '40411888', 'type': 'BACKGROUND', 'citation': 'Dundar 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.'}, {'pmid': '29492231', 'type': 'BACKGROUND', 'citation': 'Muigai 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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe main questions it aims to answer are:\n\n* Does providing peer education module and an educational brochure about SVE increase students' knowledge levels regarding SVE?\n* 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.\n\nStudents; After the pretest, they will learn about KKVM through a peer education module or educational brochure, or they will be in the control group.\n\nThree months later, a posttest will assess their knowledge and behaviors about KKVM.", 'detailedDescription': "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.\n\nDuring 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'.\n\nIntervention 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Being a female student in the Yeditepe University Faculty of Health Sciences, Department of Nursing\n\n * Not having had a previous vulvar mass or cancer\n * Not having any communication barriers\n * Being able to read and understand Turkish\n * Having a mobile phone with internet access.\n\nExclusion Criteria:\n\n* • Not being a female student in the Yeditepe University Faculty of Health Sciences Nursing Department\n\n * Having previously had a vulvar mass or cancer\n * Having any communication barriers\n * Not being able to read or understand Turkish\n * Not having a mobile phone with internet access'}, 'identificationModule': {'nctId': 'NCT07479459', 'acronym': 'SVE', 'briefTitle': 'Different Education Methods and Self Vulvar Examination (SVE)', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'E-56365223-050.04-2025.137548.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention 1 ( Brochure Group)', 'description': '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.', 'interventionNames': ['Behavioral: Brochure']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 2 (Peer Education Group)', 'description': "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.", 'interventionNames': ['Behavioral: Peer Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': "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.", 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Brochure', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention 1 ( Brochure Group)']}, {'name': 'Peer Education', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention 2 (Peer Education Group)']}, {'name': 'Control', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}