Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 9:21 AM
Study NCT ID:
NCT07276659
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Contribution of Scenario Writing to Learning Stoma Care in Nursing Education: A Mixed-Methods Quasi-Experimental Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking was applied; participants and investigators were aware of group assignments'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm quasi-experimental design with an intervention group receiving scenario-writing-based stoma care education and a passive control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-11-29', 'studyFirstSubmitQcDate': '2025-11-29', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stoma Care Knowledge Score', 'timeFrame': 'Baseline (Week 0) and Post-intervention (Week 8)', 'description': "Change in students' stoma care knowledge score from pre-test to post-test. Knowledge will be measured using a 20-item Stoma Care Knowledge Questionnaire developed by the research team. Scores range from 0 to 20, with higher scores indicating greater knowledge. The primary analysis will compare post-test scores between the intervention and control groups, adjusting for baseline knowledge."}], 'secondaryOutcomes': [{'measure': "Qualitative Themes Related to Students' Perceived Confidence and Skill Development", 'timeFrame': 'Immediately after completion of the 8-week intervention (same week as the post-test).', 'description': 'Semi-structured focus group interviews will be conducted with participants in the intervention group after completion of the 8-week program. Qualitative analysis (thematic analysis) will explore changes in perceived confidence, perceived competence, motivation for practice, and learning experiences related to scenario writing and role-play activities. Themes will be identified using coded transcripts analyzed with MAXQDA by two independent researchers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stoma Care', 'Scenario-Based Learning', 'Nursing Education'], 'conditions': ['Stoma Care Education in Nursing Students']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the effectiveness of scenario writing and role-play-based learning on nursing students' knowledge related to stoma care. The study uses a mixed-methods, quasi-experimental design including an intervention and a control group. Students in the intervention group participate in an eight-week scenario-based learning program consisting of scenario writing, dramatization (role-play), and structured feedback sessions. The control group receives no additional educational activity beyond the standard curriculum. Stoma care knowledge is assessed using a pre-test administered on October 27, 2025, and a post-test administered on December 22, 2025. In addition, qualitative data are collected from intervention-group participants through semi-structured focus group interviews to explore changes in confidence, perceived skills, and learning experiences. The goal of the study is to determine whether scenario-based learning strengthens the acquisition of stoma care knowledge and enhances students' educational experiences.", 'detailedDescription': "This mixed-methods quasi-experimental study investigates the impact of scenario-based learning on nursing students' acquisition of stoma care knowledge. Third-year nursing students who previously completed the surgical nursing course were eligible for participation. The intervention group engaged in an eight-week Scenario-Based Stoma Care Learning Program, which included (1) preparation and writing of clinical scenarios, (2) dramatization and role-play activities using simulated clinical environments, and (3) structured instructor-guided feedback. The control group did not receive any additional training and completed only the pre-test and post-test assessments.\n\nThe pre-test measuring stoma care knowledge was administered on October 27, 2025. The post-test was administered on December 22, 2025, following completion of all scenario-based learning sessions. After the educational intervention, qualitative data were collected from the intervention group through focus group interviews using a COREQ-aligned semi-structured interview guide. Qualitative data aim to explore changes in participants' confidence, perceived skills, learning processes, and their experience with scenario writing and role-play.\n\nThe study's primary objective is to determine whether scenario-based learning improves students' stoma care knowledge. Secondary objectives include understanding how scenario writing and dramatization influence students' confidence, engagement, and perceived competence in performing stoma care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a 3rd-year undergraduate nursing student in the Nursing Department.\n* Having successfully completed the Surgical Nursing course in the 2nd year.\n* Voluntarily agreeing to participate in the study and providing informed consent.\n\nExclusion Criteria:\n\n* Students who did not pass the Surgical Nursing course.\n* Students who have previously received professional stoma care training.\n* Students who complete the data collection forms incompletely.'}, 'identificationModule': {'nctId': 'NCT07276659', 'briefTitle': 'The Contribution of Scenario Writing to Learning Stoma Care in Nursing Education: A Mixed-Methods Quasi-Experimental Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'The Contribution of Scenario Writing to Learning Stoma Care in Nursing Education: A Mixed-Methods Quasi-Experimental Intervention Study', 'orgStudyIdInfo': {'id': 'VYYU-SBF-HAKALTUN-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scenario-Based Stoma Care Education', 'description': 'Participants in the intervention arm will receive an 8-week scenario-based stoma care education program.\n\nThe intervention includes:\n\n* 4 weeks of scenario writing sessions,\n* 4 weeks of role-play/dramatization in the skills laboratory,\n* Structured feedback by the instructor. No additional theoretical lecture will be provided. Participants complete pre-test and post-test assessments, and qualitative focus group interviews will be conducted after completion of the intervention.', 'interventionNames': ['Behavioral: Scenario-Based Stoma Care Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in the control arm will not receive any additional education or training.\n\nThey will complete the same pre-test and post-test assessments as the intervention group.\n\nNo scenario writing or role-play activities will be administered.'}], 'interventions': [{'name': 'Scenario-Based Stoma Care Education', 'type': 'BEHAVIORAL', 'description': 'A structured scenario-writing and role-play-based educational program delivered over 8 weeks. Students develop stoma care scenarios, present them, and perform role-play using simulated patients and a skills laboratory environment. The intervention includes scenario writing sessions (4 weeks) and stoma care role-play practice using manikins and real materials (4 weeks), followed by structured educator feedback.', 'armGroupLabels': ['Scenario-Based Stoma Care Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65090', 'city': 'Van', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'hatice akaltun, PhD', 'role': 'CONTACT', 'email': 'haticeakaltun@yyu.edu.tr', 'phone': '05425955326'}, {'name': 'hatice akaltun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Van Yuzuncu Yil Univeristy', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'centralContacts': [{'name': 'hatice akaltun, PhD', 'role': 'CONTACT', 'email': 'haticeakaltun@yyu.edu.tr', 'phone': '05425955326'}], 'overallOfficials': [{'name': 'hatice akaltun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the ethical approval does not permit disclosure of identifiable or de-identified participant-level data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'hatice akaltun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer (PhD) in Nursing', 'investigatorFullName': 'hatice akaltun', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}