Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-01-13 @ 5:39 PM
Study NCT ID:
NCT01875900
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2013-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal resuscitation performance', 'timeFrame': 'Students will take part in an Objective Structured Clinical Examination (OSCE) within two weeks after having participated in the course.', 'description': 'Students will perform neonatal resuscitation as part of an OSCE.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of instructional methodology, success of OSCE preparation, transferability of skills into patient care', 'timeFrame': 'within two weeks', 'description': 'Students will be asked to rate the subjective effectiveness of the respective instructional methodology, success of OSCE preparation, and transferability of skills into patient care using a questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neonatal resuscitation', 'video-assisted learning', 'self-directed training', 'simulation', 'simulation-based training', 'simulation-based medical education', 'objective structured clinical examination'], 'conditions': ['Resuscitation', 'Neonatology']}, 'descriptionModule': {'briefSummary': 'Simulation-based training has been widely implemented in medical education. According to educational theories, simulation-based medical education (SBME) is associated with significant advantages, which has been investigated and proved by many studies. However, the value of SBME in comparison to other instructional methodologies remains largely unknown. Therefore, the aim of this study is to directly compare two instructional methods for neonatal resuscitation training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fifth-year medical students prior to their mandatory OSCE\n* Signing of informed consent\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n\nThe first two OSCEs in July and August will be part of a pilot study. The combined results of both examinations will be used for a sample size calculation.'}, 'identificationModule': {'nctId': 'NCT01875900', 'briefTitle': 'Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Instructor-led Simulation Training Versus Self-directed Simulator Training During Simulated Neonatal Resuscitation - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '25-399 ex 12/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Video-assisted learning and self-directed training', 'description': 'The Neonatal Resuscitation Program (NRP) digital video disc (DVD) will be provided for video study and a low-fidelity newborn manikin for self-directed resuscitation training (90 minutes training time, six students per group).', 'interventionNames': ['Other: Video-assisted learning and self-directed training']}, {'type': 'EXPERIMENTAL', 'label': 'Simulation-based neonatal resuscitation training', 'description': 'Students will learn initial assessment of newborns and basic resuscitation skills and actively apply these skills during simulated clinical scenarios both with a low- and high-fidelity manikin (90 minutes training time, six students per group).', 'interventionNames': ['Other: Simulation-based neonatal resuscitation training']}], 'interventions': [{'name': 'Video-assisted learning and self-directed training', 'type': 'OTHER', 'otherNames': ['Visual learning and independent neonatal resuscitation training'], 'description': 'The Neonatal Resuscitation Program (NRP) DVD will be provided for video study and a low-fidelity newborn manikin for self-directed resuscitation training (90 minutes training time, six students per group).', 'armGroupLabels': ['Video-assisted learning and self-directed training']}, {'name': 'Simulation-based neonatal resuscitation training', 'type': 'OTHER', 'otherNames': ['Instructor-led neonatal resuscitation training'], 'description': 'Students will learn initial assessment of newborns and basic resuscitation skills and actively apply these skills during simulated clinical scenarios both with a low- and high-fidelity manikin (90 minutes training time, six students per group).', 'armGroupLabels': ['Simulation-based neonatal resuscitation training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Clinical Skills Center, Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Georg Schmölzer, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria; Department of Pediatrics, University of Alberta, Edmonton, Canada'}, {'name': 'Berndt Urlesberger, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of Graz, Austria'}, {'name': 'Ernst Eber, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Respiratory and Allergic Disease Division , Department of Pediatrics, Medical University of Graz, Austria'}, {'name': 'Albrecht Schmidt, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria; Clinical Skills Center, Medical University of Graz, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'cand.med.', 'investigatorFullName': 'Lukas P Mileder, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}