Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT05332535
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serious Game On Stoma Care Education For Nursing Students
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To determine permanence of the method', 'timeFrame': '4 week', 'description': 'The results obtained after the application will be analyzed and the impact of serious game based virtual reality mobile application on stoma care education will be determined. The scale consists of three sub-dimensions as system usefulness (items 1-6), quality of information (items 7-9), and interface quality (items 10-12), and item 13 measures overall satisfaction. Each item is scored as 1 (Strongly agree) - 7 (Strongly disagree). A low score from the scale indicates high usability.'}], 'primaryOutcomes': [{'measure': "To measure nursing student's information", 'timeFrame': '4 week', 'description': "The data will be collected through introductory features form, 'Stoma Care Information Form', In the first stage of the study, the students will be given a 'Stoma Care Information Form' (first knowledge). 'Stoma Care Information Form' (second information) will be applied after completing the theoretical lesson of stoma care and group work in the laboratory of students in the experimental and control groups. There are 20 questions on the subject in the knowledge test and the lowest 0 and the highest 20 points are taken from the test. Increasing score indicates higher achievement."}], 'secondaryOutcomes': [{'measure': "To measure nursing student's skill", 'timeFrame': '4 week', 'description': "Unlike the control group, the mobile phones of students in the experimental group; A serious game-based virtual reality mobile application on stoma care prepared as a support for formal education will be installed. After the students play the application, skill measurements will be made in the laboratory with 'Skill Checklists'. Skill measurements of students will be made with an objective structured clinical exam.The skill checklist includes 36 process steps that students are expected to perform. 2 points were given for each correct step evaluated in the list, 1 point for the missing step, and 0 points for each unfulfilled step. A minimum of 0 and a maximum of 72 points can be obtained from the skill checklist. Increasing score indicates higher achievement."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Education', 'Nursing', 'Student', 'Surgical stoma', 'Video games'], 'conditions': ['Surgical Stoma', 'Nursing', 'Video Games']}, 'descriptionModule': {'briefSummary': 'Today, rapidly developing technology needs to be integrated into teaching environments and reconstructed teaching environments. When virtual reality applications, which are among the popular and innovative technologies, are examined, it is seen that participants are used in many areas of education. In this randomized controlled study, it was aimed to evaluate the impact of stoma care education by designing a serious game based web application that enables nursing students to gain skills and practice in psychomotor applications. The universe of the study will be students enrolled in the Surgical Diseases Nursing course in the spring semester of the 2020-2021 academic year at the Faculty of Health Sciences, Gümüşhane University. Students will be divided into two groups as control and experiment by randomization method. The data will be collected through introductory features form, \'Stoma Care Information Form\', \'Stoma Care Skill Checklist\' and Computer System Usability Survey. In the first stage of the study, the students will be given a \'Stoma Care Information Form\' (first knowledge). \'Stoma Care Information Form\' (second information) and \'Stoma Care Skill Checklist\' will be applied after completing the theoretical lesson of stoma care and group work in the laboratory of students in the experimental and control groups. Unlike the control group, of students in the experimental group; A serious game-based web application on stoma care prepared as a support for formal education will be installed. After four weeks of the students attending formal education, \'Stoma Care Information Form\' (third knowledge) and \'Stoma Care Skill Checklist\' (second skill) will be applied. In the experiment and control group, two weeks later, the "Stoma Care Information Form" (fourth information) and "Stoma Care Skill Checklist" (third skill) will be applied again to test the permanence of the methods. Skill measurements of students will be made with an objective structured clinical exam. The results obtained after the application will be analyzed and the impact of serious game based web application on stoma care education will be determined'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolling in the HEMSEC-217 Emergency Nursing course for the first time,\n* Having successfully completed the Internal Medicine Nursing course,\n* He voluntarily agreed to participate in the study.\n* Having internet access\n\nExclusion Criteria:\n\n* To have received training (in-service training, course, seminar, etc.) on stoma care,\n* Having graduated from a health vocational high school and having experience in stoma care,\n* Taking the HEMSEC-217 Emergency Nursing course for the second time'}, 'identificationModule': {'nctId': 'NCT05332535', 'briefTitle': 'Serious Game On Stoma Care Education For Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'Gümüşhane Universıty'}, 'officialTitle': 'Effect Of Serious Game-Based Web Application On Stoma Care Education For Nursing Students', 'orgStudyIdInfo': {'id': 'GumushaneU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serious game web aplication', 'description': 'Nursing students played the serious game for two weeks.', 'interventionNames': ['Behavioral: serious game based web application education']}, {'type': 'NO_INTERVENTION', 'label': 'Control grup'}], 'interventions': [{'name': 'serious game based web application education', 'type': 'BEHAVIORAL', 'description': 'serious game based web application education for nursing students', 'armGroupLabels': ['Serious game web aplication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29100', 'city': 'Gümüşhane', 'country': 'Turkey (Türkiye)', 'facility': 'Nurşen Kulakaç', 'geoPoint': {'lat': 40.46001, 'lon': 39.47176}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available 01.06.2022 and 01.12.2020', 'ipdSharing': 'YES', 'accessCriteria': 'Non'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gümüşhane Universıty', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Nursen Kulakac', 'investigatorAffiliation': 'Gümüşhane Universıty'}}}}