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AR vs In Person Simulation for Medical Workplace Training

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05674188
Collaborator
(none)
200
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. One group will wear an AR headset and participate in an AR medical crisis scenario and the other group will participate in the same scenario with a traditional, mannequin based in situ simulation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Augmented Reality Headset
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Physiologic and Emotional Effects of Augmented Reality Simulation Versus In Person Simulation - A Noninferiority, Randomized Controlled Trial
Anticipated Study Start Date :
Mar 3, 2023
Anticipated Primary Completion Date :
Mar 3, 2024
Anticipated Study Completion Date :
Mar 3, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Augmented Reality Enhanced Simulation (Treatment group)

Participants will experience augmented simulations with a holographic mixed-reality setting based on different workplace scenarios such as medical error and workplace harassment via Augmented Reality (AR) headset.

Behavioral: Augmented Reality Headset
Augmented simulation of workplace-related scenarios of pre-recorded videos using the same actors
No Intervention: Traditional In Situ Simulation (Control group)

Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment

Outcome Measures

Primary Outcome Measures

  1. Parasympathetic withdrawal [Duration of simulation (15-20 minutes)]

    Measured via respiratory sinus arrhythmia (RSA) in hertz

  2. Sympathetic activation [Duration of simulation (15-20 minutes)]

    Increases in skin conductance in reactivation (microsiemens)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included
Exclusion Criteria:

  • Participants with reported severe motion sickness

  • Nausea

  • Seizure disorder

  • Currently using chronotropic heart medications, such as β blockers

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Thomas J Caruso, MD, MEd, Clinical Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Caruso, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05674188
Other Study ID Numbers:
  • 68663
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 13, 2023