Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07274618
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Group Based Reverse OSCE" for Teaching Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical ventilation knowledge', 'timeFrame': '1 day', 'description': "To assess students' knowledge and clinical reasoning in mechanical ventilation, a researcher-developed, mixed-format questionnaire was used. The tool included 20 items such as multiple-choice questions, clinical scenarios, calculation-based items (e.g., RSBI, ventilator settings), and graphic interpretation tasks. Content areas covered ventilator modes, complications, alarm settings, ABG analysis, and weaning criteria, designed in alignment with recent guidelines including the American Heart Association (2023)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Simulation-based education', 'Mechanical ventilation training', 'Reverse OSCE', 'Competency-based medical education', 'Nursing students'], 'conditions': ['Medical Education', 'Nursing Students']}, 'descriptionModule': {'briefSummary': 'Introduction: Mechanical ventilation (MV) is a critical skill for healthcare professionals, yet traditional teaching methods often fail to adequately prepare students. This study evaluates the effectiveness of an innovative Group-Based Reverse OSCE.\n\nMethods: A quasi-experimental study was conducted with 70 nursing students randomly assigned to either the Reverse OSCE group (n=35) or traditional lecture-based group (n=35). The intervention consisted of a 10-hour workshop featuring five interactive OSCE stations covering ventilator hardware, settings, modes, and alarm management. Knowledge and skills were assessed using validated pre- and post-tests, with statistical analysis performed via independent and paired t-tests (SPSS v25).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nstudents from the nursing discipline who were in their clinical internship or clerkship students who completed relevant coursework in respiratory physiology, and had successfully passed the theoretical course in critical care.\n\nno prior participation in similar ventilator training workshops within the past six months, demonstrating willingness for voluntary participation, and being able to attend the full 10-hour workshop (including both theoretical and practical components).\n\nExclusion Criteria:\n\npartial attendance in the workshop, withdrawal at any stage of the study the occurrence of acute medical or emergency conditions interfering with participation or failure to complete the pre- and post-intervention assessment tools.'}, 'identificationModule': {'nctId': 'NCT07274618', 'briefTitle': '"Group Based Reverse OSCE" for Teaching Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Torbat Heydariyeh University of Medical Sciences'}, 'officialTitle': '"Group Based Reverse OSCE" for Teaching Mechanical Ventilation to Nursing Students: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '402000038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control group', 'description': 'traditional method of education is being provided in this group', 'interventionNames': ['Other: mechanical ventilation (MV)']}], 'interventions': [{'name': 'mechanical ventilation (MV)', 'type': 'OTHER', 'description': 'in this educational intervention, nursing students are allocated to the reverse OSCE group in which the OSCE is being used for teaching mechanical ventilation education instead of acquiring test from student.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torbat-e Ḩeydarīyeh', 'country': 'Iran', 'facility': 'Torbat-e Heydariyeh University of Medical Sciences', 'geoPoint': {'lat': 35.27401, 'lon': 59.21949}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study has been conducted on nursing student and confidentiality of data was promised to participants before this study began'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torbat Heydariyeh University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of program', 'investigatorFullName': 'Alireza Sardashti', 'investigatorAffiliation': 'Torbat Heydariyeh University of Medical Sciences'}}}}