AR vs In Person Simulation for Medical Workplace Training

The Physiologic and Emotional Effects of Augmented Reality Simulation Versus In Person Simulation - A Noninferiority, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Augmented Reality
• Intervention / Treatment: Behavioral: Augmented Reality Headset

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parasympathetic response indexed by RSA	Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.	Duration of simulation (15-20 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sytem Usability Scale (SUS)	10-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to measure usability. Only administered to the AR group.	Post-simulation (5 minutes)
ISO 9241-400	6-item ergonomic questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale only administered to the AR group.	Post-simulation (5 minutes)
Simulation Design Scale (SDS)	20-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to assess user satisfaction	Post-simulation (5-10 minutes)
Learning effectiveness	Five months post-simulation, an assessment was sent out to participants with a 10-item, multiple choice with questions related to key learning points about resuscitation management.	5 months-post simulation (5 minutes)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Thomas J Caruso, MD, MEd, clinical professor

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): March 22, 2023
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 68663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No