Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-04 @ 11:00 PM
Study NCT ID:
NCT06536192
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Gynecological Examination Skills with the Use of a Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving gynecological examination skills with the use of a model', 'timeFrame': 'Groups of 5 people receive 15 minutes of laboratory training and 15 days later, practice in the laboratory.', 'description': 'Gynecologic Disease'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midwife, student, gynecological examination, model'], 'conditions': ['Gynecologic Nursing', 'Training Group, Sensitivity', 'Gynecologic Disease']}, 'descriptionModule': {'briefSummary': "Vaginal, abdominal, and breast examinations are among the essential gynecological examination skills for midwifery students and are crucial steps that need to be learned. However, due to the privacy of genital areas, there are some debates regarding the teaching of these skills. Low-fidelity mannequins and models are particularly effective and cost-efficient in acquiring basic psychomotor skills. Thus, midwifery students can gain clinical experience, make mistakes in a safe environment, and enhance their skills. The sample of this study consists of 64 midwifery students (experimental=32, control=32) using a pre-test, post-test design with an observational randomized controlled trial. Data collection instruments include a Personal Information Form (PIF), Learner's Guide (LG), Self-Confidence Scale (SCS), and Self-Confidence in Learning Scale (SSSCLS. In the experimental group, after providing theoretical knowledge, students will receive practical training on a gynecological examination model, including bimanual examination, vaginal examination with a speculum, pap smear for cervical screening, and pelvic palpation. Each student will then perform the examination individually, with approximately 15 minutes allocated per student. Two weeks later, the same students will be asked to perform all examination steps again. During the examinations, the researcher will mark complete and incomplete procedures in the learner's guide, and any deficiencies will be explained to the students for completion. The CS and SSSLS will be administered for the post-test. In the control group, after theoretical knowledge is provided, students will be shown visual and video demonstrations of the steps of a gynecological examination. The PIF and SCS will be administered for the pre-test, and two weeks later, students will be asked to perform the examination steps in a laboratory setting, followed by the post-test.", 'detailedDescription': "Gynecological examination is an important step for women's health. Early diagnosis, treatment, intervention, and follow-up are the foundation of a healthy life. Midwives play an important role in maintaining women's health, especially in conducting detailed gynecological and obstetric evaluations. They should receive quality theoretical education and improve their practices. Practical training is important in learning, especially in the health field where models and simulation applications play a significant role in clinical practices. Therefore, clinical examination skills are sometimes taught to students using different materials, making it easier for students to learn medical knowledge and reducing the time spent on education. The aim of this planned study is to improve midwifery students' gynecological examination skills with model support."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences\n\n * Being between the ages of 18-25\n * Voluntarily agreeing to participate in the study\n * Being a citizen of the Republic of Turkey\n\nExclusion Criteria:\n\n* Leave whenever you want without working.'}, 'identificationModule': {'nctId': 'NCT06536192', 'briefTitle': 'Improving Gynecological Examination Skills with the Use of a Model', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Improving Gynecological Examination Skills in Midwifery Students: a Training Study Using Models', 'orgStudyIdInfo': {'id': 'E-77192459-050.99-338662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Model) group', 'description': '1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment.\n2. Process: The learner guide will be filled out.\n3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, Self-Confidence Scale (SCS) and Student Satisfaction and Self-Confidence in Learning Scale (SSSLS) will be filled out for the last exam.', 'interventionNames': ['Other: Model group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "1. Procedure: The stages of gynecological examination evaluation for students, its purpose, the process of preparing the patient and evaluating them will be provided with theoretical knowledge.\n2. Procedure: Pre-tests will be administered.\n3. Procedure: Two weeks later, Self-Confidence Scale (SCS); Learner's Guide (LG) and (Student Satisfaction and Self-Confidence in Learning Scale) SSSCLS will be filled out for the final test."}], 'interventions': [{'name': 'Model group', 'type': 'OTHER', 'description': '1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment.\n2. Process: The learner guide will be filled out.\n3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, SCS and SSSLS will be filled out for the last exam.', 'armGroupLabels': ['Intervention (Model) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78050', 'city': 'Karabük', 'state': 'Karabük Province', 'country': 'Turkey (Türkiye)', 'facility': 'Karabük University', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}, {'zip': '78050', 'city': 'Karabük', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Ayşe Çuvadar', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ayse Cuvadar', 'investigatorAffiliation': 'Karabuk University'}}}}