NCT01509794

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

January 9, 2012

Last Update Submit

March 27, 2013

Conditions

Healthy

Keywords

CMESimulationAffective engagementCognitive performance

Outcome Measures

Primary Outcomes (1)

  • Engagement with simulation

    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 Outcomes (1)

  • Cognitive performance

    All data will be collected during the one hour when participants engage in the simulation activities and debriefing.

Study Arms (2)

Low Valence

ACTIVE COMPARATOR

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

High Valence

EXPERIMENTAL

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

Interventions

Low ValenceOTHER

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.

Low Valence
High ValenceOTHER

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.

High Valence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare provider
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital, Division of Postgraduate Medical Education

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 21804041BACKGROUND

Study Officials

  • Tristan Gorrindo, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Division of Post-Graduate Medical Education

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 13, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

US(1)