Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT01509794
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2012-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychophysiological Indicators of Performance in Computer-Based Simulation
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement with simulation', 'timeFrame': 'All data will be collected during the one hour when participants engage in the simulation activities and debriefing.', 'description': 'Participant engagement with simulation will be measured using physiological measures of heart rate variability and galvanic skin response as well as self-report measures during the verbal debriefing.'}], 'secondaryOutcomes': [{'measure': 'Cognitive performance', 'timeFrame': 'All data will be collected during the one hour when participants engage in the simulation activities and debriefing.', 'description': 'Cognitive performance will be assessed based on the choices that participants make during the clinical simulation as well as the details that they retain and express during the written debriefing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CME', 'Simulation', 'Affective engagement', 'Cognitive performance'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '21804041', 'type': 'BACKGROUND', 'citation': 'Gorrindo T, Baer L, Sanders KM, Birnbaum RJ, Fromson JA, Sutton-Skinner KM, Romeo SA, Beresin EV. Web-based simulation in psychiatry residency training: a pilot study. Acad Psychiatry. 2011 Jul-Aug;35(4):232-237. doi: 10.1176/appi.ap.35.4.232.'}]}, 'descriptionModule': {'briefSummary': 'As simulation is now used in many post-graduate education and assessment domains, the investigators want to learn about how autonomically engaged healthcare providers are with the investigators computer simulation paradigm. The investigators are interested in the relationship between autonomic arousal (as measured by heart rate variability and galvanic skin response), self-report of engagement, and performance in the simulation and cognitive debriefing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare provider\n* Right-handed\n\nExclusion Criteria:\n\n* Has a medical condition associated with cardiac arrhythmia\n* Taking medications (such as antiarrhythmic or beta-blocker) that has an effect on heart rate or autonomic function'}, 'identificationModule': {'nctId': 'NCT01509794', 'briefTitle': 'Psychophysiological Indicators of Performance in Computer-Based Simulation', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Psychophysiological Indicators of Performance in Computer-Based Simulation', 'orgStudyIdInfo': {'id': '2011-P-000906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Valence', 'description': 'Participants in the low valence condition will participate in photo-based simulations. They will see a photo of the patient and hear affectively flattened audio. The script and clinical information remain the same as the high valence condition.', 'interventionNames': ['Other: Low Valence']}, {'type': 'EXPERIMENTAL', 'label': 'High Valence', 'description': 'Participants in the high valence condition will participate in video-based simulations. They will see a rich multimedia presentation of the clinical encounter, with affectively enhanced audio. The script and clinical information remain the same as the low valence condition.', 'interventionNames': ['Other: High Valence']}], 'interventions': [{'name': 'Low Valence', 'type': 'OTHER', 'description': 'Participants in the low valence condition will participate in two photo-based simulations: first, an orientation to become familiar with the interface, and then a clinical simulation. Afterward, they will complete a written debriefing followed by an verbal debriefing with a study investigator. They will complete all activities while having their heart rate and galvanic skin response monitored using non-invasive methods.', 'armGroupLabels': ['Low Valence']}, {'name': 'High Valence', 'type': 'OTHER', 'description': 'Participants in the low valence condition will participate in two video-based simulations: first, an orientation to become familiar with the interface, and then a clinical simulation. Afterward, they will complete a written debriefing followed by an verbal debriefing with a study investigator. They will complete all activities while having their heart rate and galvanic skin response monitored using non-invasive methods.', 'armGroupLabels': ['High Valence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital, Division of Postgraduate Medical Education', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Tristan Gorrindo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director, Division of Post-Graduate Medical Education', 'investigatorFullName': 'Tristan Gorrindo', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}