NCT05674188

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

2 days

First QC Date

December 21, 2022

Last Update Submit

December 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Sytem Usability Scale (SUS)

    Post-simulation (5 minutes)

  • ISO 9241-400

    Post-simulation (5 minutes)

  • Simulation Design Scale (SDS)

    Post-simulation (5-10 minutes)

  • Learning effectiveness

    5 months-post simulation (5 minutes)

Study Arms (2)

Augmented Reality Enhanced Simulation (Treatment group)

EXPERIMENTAL

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

Traditional In Situ Simulation (Control group)

NO INTERVENTION

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

Interventions

Augmented simulation of workplace-related scenarios of pre-recorded videos using the same actors

Augmented Reality Enhanced Simulation (Treatment group)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Participants with reported severe motion sickness
  • Nausea
  • Seizure disorder
  • Currently using chronotropic heart medications, such as β blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Rama A, Rojas-Pino MS, Wang EY, Rodriguez ST, Suen MY, Titzler JS, Zuniga-Hernandez M, Jackson C, Rosales O, Collins F, Caruso TJ. The Physiologic Effect of Augmented Reality Simulation Versus Traditional Simulation: A Noninferiority, Randomized Controlled Trial. J Educ Perioper Med. 2025 Apr 8;27(1):E740. doi: 10.46374/VolXXVII_Issue1_Rama. eCollection 2025 Jan-Mar.

Study Officials

  • Thomas J Caruso, MD, MEd

    clinical professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

March 20, 2023

Primary Completion

March 22, 2023

Study Completion

March 22, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations