Psychophysiological Indicators of Performance in Computer-Based Simulation

March 27, 2013 updated by: Tristan Gorrindo, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital, Division of Postgraduate Medical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All data will be collected during the one hour when participants engage in the simulation activities and debriefing.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All data will be collected during the one hour when participants engage in the simulation activities and debriefing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Tristan Gorrindo, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-P-000906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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