Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-22 @ 4:15 PM
Study NCT ID:
NCT01645566
Status:
COMPLETED
Last Update Posted:
2012-07-20
First Post:
2012-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Task Focusing Strategy During a Simulated Cardiopulmonary Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-19', 'studyFirstSubmitDate': '2012-07-15', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perceived levels of stress and feeling overwhelmed (stress/overload)', 'timeFrame': 'time from start of CPR until scenario is finished (usually 5-10min)', 'description': 'This is a simulator study and the study starts after students entered the simulator and the manikin has a cardiac arrest. The scenarios usually last for not more than 5-10 min at which time point the study is finished'}], 'secondaryOutcomes': [{'measure': 'hands-on time', 'timeFrame': 'time from start of CPR until scenario is finished (usually 5-10min)', 'description': 'This is a simulator study and the study starts after students entered the simulator and the manikin has a cardiac arrest. The scenarios usually last for not more than 5-10 min at which time point the study is finished'}, {'measure': 'time to start CPR', 'timeFrame': 'time from start of CPR until scenario is finished (usually 5-10min)'}, {'measure': 'Number of leadership statements', 'timeFrame': 'time from start of CPR until scenario is finished (usually 5-10min)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiopulmonary resuscitation', 'stress', 'intervention'], 'conditions': ['Mental Stress']}, 'referencesModule': {'references': [{'pmid': '22115935', 'type': 'BACKGROUND', 'citation': 'Hunziker S, Semmer NK, Tschan F, Schuetz P, Mueller B, Marsch S. Dynamics and association of different acute stress markers with performance during a simulated resuscitation. Resuscitation. 2012 May;83(5):572-8. doi: 10.1016/j.resuscitation.2011.11.013. Epub 2011 Nov 22.'}, {'pmid': '21695475', 'type': 'BACKGROUND', 'citation': 'Hunziker S, Laschinger L, Portmann-Schwarz S, Semmer NK, Tschan F, Marsch S. Perceived stress and team performance during a simulated resuscitation. Intensive Care Med. 2011 Sep;37(9):1473-9. doi: 10.1007/s00134-011-2277-2. Epub 2011 Jun 22.'}, {'pmid': '21658557', 'type': 'BACKGROUND', 'citation': 'Hunziker S, Johansson AC, Tschan F, Semmer NK, Rock L, Howell MD, Marsch S. Teamwork and leadership in cardiopulmonary resuscitation. J Am Coll Cardiol. 2011 Jun 14;57(24):2381-8. doi: 10.1016/j.jacc.2011.03.017.'}, {'pmid': '23607331', 'type': 'DERIVED', 'citation': 'Hunziker S, Pagani S, Fasler K, Tschan F, Semmer NK, Marsch S. Impact of a stress coping strategy on perceived stress levels and performance during a simulated cardiopulmonary resuscitation: a randomized controlled trial. BMC Emerg Med. 2013 Apr 22;13:8. doi: 10.1186/1471-227X-13-8.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized controlled study. The aim of this study is to\n\n1. describe the stress patterns experienced during a CPR situation;\n2. investigate whether the perceived stress was associated with CPR performance in terms of hands-on time and time to start CPR;\n3. to investigate whether this task focusing strategy reduces perceived stress levels, and\n4. whether this translates into better CPR performance. Based on findings that clear, directive leadership can enhance performance in cardiac resuscitation, we further 5) investigate if stress was associated with fewer leadership statements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4th year medical students\n\nExclusion Criteria:\n\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT01645566', 'briefTitle': 'Task Focusing Strategy During a Simulated Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Impact of a Task Focusing Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BS1330978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'instructions about focusing on relevant task elements by posing two task-focusing questions ("what is the patient\'s condition?", "what immediate action is needed?") when feeling overwhelmed by stress (intervention-group)', 'interventionNames': ['Behavioral: instruction']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No instructions'}], 'interventions': [{'name': 'instruction', 'type': 'BEHAVIORAL', 'description': 'instructions about focusing on relevant task elements by posing two task-focusing questions ("what is the patient\'s condition?", "what immediate action is needed?") when feeling overwhelmed by stress (intervention-group)', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Sabina Hunziker, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Medical Intensive Care Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Philipp Schuetz', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}