Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 4:39 AM
Study NCT ID:
NCT06749769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation-Based Learning Experience in Strengthening Stoma Care Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stoma Care Skills Rubric', 'timeFrame': 'Post-operative 3rd day', 'description': "It consists of 23 items that include stoma care process steps. The learner's competence for each process step is scored between 0-2 (0- Insufficient 1- Partially sufficient 2- Sufficient). A minimum of 0 and a maximum of 46 points can be obtained. The total score shows the competence of stoma care skills."}, {'measure': 'Generalized Perceived Self-Efficacy Scale', 'timeFrame': 'at the time of enrollement, and Post-operative 3rd day', 'description': "It consists of 10 items, and each item of the scale is scored between 1 and 4. These are listed as not true (1), somewhat true (2), more true (3), and completely true (4). Minimum of 10 and a maximum of 40 points can be obtained. The higher the score, the higher the individual's perceived self-efficacy."}], 'secondaryOutcomes': [{'measure': 'State Anxiety Level', 'timeFrame': 'at the time of enrollement, and post-operative 3rd day', 'description': 'In the study, the state anxiety scale will be used to determine the anxiety levels of the patients during the application. The State Anxiety Scale (SAS) provides information about what the individual feels at that moment. The State Anxiety Scale is a Likert-type scale consisting of 20 items, rated between 1 (not at all) and 4 (completely).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stoma care', 'patient education', 'simulation', 'patient's learning experience', 'Strengthening patients'], 'conditions': ['Stoma']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma.\n\nThe main hypothesis it aims to test are:\n\nH1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing stoma care.\n\nH2: Simulation-based learning experience is effective in increasing stoma patients' stoma care skills.\n\nH3: Simulation-based learning experience is effective in increasing stoma patients' perceived self-efficacy regarding stoma care.\n\nResearchers will compare the control and study group to see if the simulation-based learning enhances the patients learning experience.\n\nParticipants will be asked to;\n\n* Answer the questions (demographic data form and anxiety scale)\n* Receive education regarding stoma care (verbal and demonstration)\n* Practice stoma care on their own"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Age 18 and above\n2. First time having a stoma and having an intestinal stoma,\n3. Communicable, open to cooperation,\n4. Able to speak and understand Turkish,\n5. Individuals who are willing to participate in the research and willing to be interviewed will be included in the research.\n\nExclusion Criteria\n\n1. Patients who develop surgical complications in their stoma.\n2. Patients who are unable to perform stoma care due to any complication\n3. Having previously received stoma care training or participated in its implementation for any reason'}, 'identificationModule': {'nctId': 'NCT06749769', 'acronym': 'SIMESEP', 'briefTitle': 'Simulation-Based Learning Experience in Strengthening Stoma Care Education', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Investigation of the Effectiveness of Simulation-Based Learning Experience in Strengthening Stoma Care Education on Patients with Stoma', 'orgStudyIdInfo': {'id': '2024-17/648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients in the control group will receive routine verbal instructions and demonstration education about their stoma care.'}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Participants in this group will receive a simulation-based stoma care education.', 'interventionNames': ['Behavioral: simulation-based education']}], 'interventions': [{'name': 'simulation-based education', 'type': 'BEHAVIORAL', 'description': 'Patients will learn how to care for their stomata on a stoma simulator', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34752', 'city': 'Istanbul', 'state': 'Other', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nuran Aysen PAMIR AKSOY, Assist. Prof.', 'role': 'CONTACT', 'email': 'aysen.aksoy@acibadem.edu.tr', 'phone': '+90 02165004405'}], 'facility': 'Acibadem Altunizade Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34752', 'city': 'Istanbul', 'state': 'Other', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nermin Ocaktan, Assist. Prof.', 'role': 'CONTACT', 'email': 'nermin.ocaktan@acibadem.edu.tr', 'phone': '+90 02165004168'}], 'facility': 'Acibadem Atakent Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Nuran Aysen Pamir Aksoy, Assist. Prof.', 'role': 'CONTACT', 'email': 'aysen.aksoy@acibadem.edu.tr', 'phone': '0 532 635 32 72', 'phoneExt': '+90'}, {'name': 'Nermin Ocaktan, Assis. Prof.', 'role': 'CONTACT', 'email': 'nermin.ocaktan@acibadem.edu.tr', 'phone': '533 737 33 06', 'phoneExt': '+90'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuran Ayşen Pamir Aksoy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Nuran Ayşen Pamir Aksoy', 'investigatorAffiliation': 'Acibadem University'}}}}