Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-01 @ 3:48 PM
Study NCT ID:
NCT06973369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Education Given With Creative Drama Method Based on Leininger's Theory on the Cultural Sensitivity and Effectiveness Levels of 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': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cultural Sensitivity Score', 'timeFrame': 'At Baseline, Immediately after training', 'description': "The participants' level of cultural sensitivity will be assessed using the Cultural Sensitivity Scale. This tool evaluates nursing students' awareness, respect, and responsiveness to cultural diversity in healthcare. The scale will be administered immediately before and after the educational intervention. The difference in scores will indicate the impact of the creative drama-based training grounded in Leininger's Transcultural Nursing Theory."}, {'measure': 'Change in Intercultural Effectiveness Score', 'timeFrame': 'At Baseline, Immediately after training', 'description': "The Intercultural Effectiveness Scale will measure the participants' intercultural effectiveness level. This scale assesses communication skills, emotional resilience, and cultural flexibility in cross-cultural interactions. The test will be administered immediately before and after the intervention. The difference in scores will indicate the impact of the creative drama-based training grounded in Leininger's Transcultural Nursing Theory."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leininger', 'Nursing students', 'Creative drama', 'Cultural sensitivity', 'Cultural effectiveness'], 'conditions': ['Nursing Education', 'Nursing Students', 'Creative Drama', 'Cultural Sensitivity']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effect of cultural care education given with creative drama method according to Leininger theory on the cultural sensitivity and effectiveness levels of nursing students. The study will be conducted as a pre-test and post-test randomized controlled experimental study. The universe of the study consists of fourth-year students (n=80) of "Agri Ibrahim Cecen University, Faculty of Health Sciences, Department of Nursing". In this study, students in the intervention and control groups will be determined by simple randomization method. After the theoretical course content is given based on Leininger theory, students in the intervention group will be given creative drama technique with cases and students in the control group will be given traditional case examples. A pre-test will be applied before the training program and a post-test will be applied after the training program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Want to participate in the study voluntarily,\n* Have taken the Intercultural Nursing course,\n* Have taken 75% of the practical nursing courses.\n\nExclusion Criteria:\n\n* Being a nurse working in the clinic,\n* Being a foreign national,\n* Being in the initiative group and not participating in the creative drama application,\n* The student wanting to leave the research at any stage,\n* Not filling out the data collection forms or filling them incompletely.'}, 'identificationModule': {'nctId': 'NCT06973369', 'briefTitle': "The Effect of Education Given With Creative Drama Method Based on Leininger's Theory on the Cultural Sensitivity and Effectiveness Levels of Nursing Students", 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': "The Effect of Education Given With Creative Drama Method Based on Leininger's Theory on the Cultural Sensitivity and Effectiveness Levels of Nursing Students", 'orgStudyIdInfo': {'id': 'ATASBEUZE001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INTERVENTION', 'interventionNames': ['Other: LEININGER THEORY BASED CREATIVE DRAMA EDUCATION METHOD']}, {'type': 'EXPERIMENTAL', 'label': 'CONTROL', 'interventionNames': ['Other: TRADITIONAL EDUCATION METHOD']}], 'interventions': [{'name': 'LEININGER THEORY BASED CREATIVE DRAMA EDUCATION METHOD', 'type': 'OTHER', 'description': "The effects of Leininger theory-based creative drama training given to nursing students for five weeks on the students' cultural sensitivity and effectiveness levels will be determined.", 'armGroupLabels': ['INTERVENTION']}, {'name': 'TRADITIONAL EDUCATION METHOD', 'type': 'OTHER', 'description': "Leininger theory training will be given to nursing students for five weeks and its effects on the students' cultural sensitivity and effectiveness levels will be determined.", 'armGroupLabels': ['CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04100', 'city': 'Ağrı', 'country': 'Turkey (Türkiye)', 'facility': 'Agri Ibrahim Cecen University', 'geoPoint': {'lat': 39.71467, 'lon': 43.04015}}], 'centralContacts': [{'name': 'Uzeyir SOLAK, Lecturer', 'role': 'CONTACT', 'email': 'usolak@agri.edu.tr', 'phone': '+90 545 294 7040'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Uzeyir SOLAK', 'investigatorAffiliation': 'Agri Ibrahim Cecen University'}}}}