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Psychophysiological Indicators of Performance in Computer-Based Simulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509794
First Posted: January 13, 2012
Last Update Posted: March 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tristan Gorrindo, Massachusetts General Hospital
  Purpose
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.

Condition Intervention
Healthy Other: Low Valence Other: High Valence

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Psychophysiological Indicators of Performance in Computer-Based Simulation

Further study details as provided by Tristan Gorrindo, Massachusetts General Hospital:

Primary Outcome Measures:
  • Engagement with simulation [ Time Frame: All data will be collected during the one hour when participants engage in the simulation activities and debriefing. ]
    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.


Secondary Outcome Measures:
  • Cognitive performance [ Time Frame: All data will be collected during the one hour when participants engage in the simulation activities and debriefing. ]
    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.


Enrollment: 17
Study Start Date: November 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Valence
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.
Other: Low Valence
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.
Experimental: High Valence
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.
Other: High Valence
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthcare provider
  • Right-handed

Exclusion Criteria:

  • Has a medical condition associated with cardiac arrhythmia
  • Taking medications (such as antiarrhythmic or beta-blocker) that has an effect on heart rate or autonomic function
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509794


Locations
United States, Massachusetts
Massachusetts General Hospital, Division of Postgraduate Medical Education
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Tristan Gorrindo, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Tristan Gorrindo, Co-Director, Division of Post-Graduate Medical Education, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01509794     History of Changes
Other Study ID Numbers: 2011-P-000906
First Submitted: January 9, 2012
First Posted: January 13, 2012
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Tristan Gorrindo, Massachusetts General Hospital:
CME
Simulation
Affective engagement
Cognitive performance


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