Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-27 @ 8:02 PM
Study NCT ID:
NCT06326450
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional In-Person Vs. Remote AR Clinical Simulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Technical Skill (TS) and Non Technical Skill (NTS) Performance', 'timeFrame': 'immediately after simulation', 'description': 'Measured with Instrument for the evaluation of advanced life support performance. The instrument consists of 26 items, which are rated on a scale from +2 to -2. A total assessment score of performance is given based on a scale from 0 to 10 (0=poor, 10=excellent) at the end of the instrument.'}], 'secondaryOutcomes': [{'measure': 'Reassessment of Non Technical Skill (NTS) with Behaviorally Anchored Rating Scale (BARS)', 'timeFrame': 'immediately after simulation', 'description': 'Measured with individual Behaviorally Anchored Rating Scale (BARS). The BARS scoring system uses four categories assessing situation awareness, decision-making, communication and teamwork. The score ranges from 1 and 9 (1 = poor and 9 = excellent)'}, {'measure': "Evaluation of the AR system's usability", 'timeFrame': 'immediately after simulation', 'description': 'Measured with the System Usability Scale (SUS). The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)'}, {'measure': "Evaluation of the AR system's ergonomics", 'timeFrame': 'immediately after simulation', 'description': 'Measured with the ISO 9241-400 Assessment of human-ergonomic factors. The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmented Reality', 'Advanced Cardiac Life Support', 'Clinical Simulation', 'Medical Education'], 'conditions': ['Educational Problems']}, 'descriptionModule': {'briefSummary': "This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brazilian resident\n\nExclusion Criteria:\n\n* a history of severe motion sickness\n* currently have nausea\n* a history of seizures\n* wear corrective glasses.'}, 'identificationModule': {'nctId': 'NCT06326450', 'acronym': 'AR Brazil', 'briefTitle': 'Traditional In-Person Vs. Remote AR Clinical Simulation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Remote Augmented Reality Versus Traditional In-person Resuscitation Assessment: an International Noninferiority Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '74626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Augmented Reality Enhanced Simulation (Treatment group)', 'description': 'Participants will experience augmented simulations with a holographic mixed-reality setting based on different workplace scenarios such as medical crisis via Augmented Reality (AR) headset.', 'interventionNames': ['Behavioral: Augmented Reality simulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional In Situ Simulation (Control group)', 'description': 'Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment', 'interventionNames': ['Behavioral: In Person simulation']}], 'interventions': [{'name': 'Augmented Reality simulation', 'type': 'BEHAVIORAL', 'description': 'Augmented simulation of medical crisis scenarios', 'armGroupLabels': ['Experimental: Augmented Reality Enhanced Simulation (Treatment group)']}, {'name': 'In Person simulation', 'type': 'BEHAVIORAL', 'description': 'In Person simulation of medical crisis scenarios', 'armGroupLabels': ['Traditional In Situ Simulation (Control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Parkard Children's Hospital", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Thomas Caruso', 'investigatorAffiliation': 'Stanford University'}}}}