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Clinical Trials/NCT05674188
NCT05674188
Completed
N/A

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

Stanford University1 site in 1 country111 target enrollmentMarch 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Augmented Reality
Sponsor
Stanford University
Enrollment
111
Locations
1
Primary Endpoint
Parasympathetic response indexed by RSA
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2023
End Date
March 22, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thomas Caruso

Clinical Associate Professor

Stanford University

Eligibility Criteria

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
  • Seizure disorder
  • Currently using chronotropic heart medications, such as β blockers

Outcomes

Primary Outcomes

Parasympathetic response indexed by RSA

Time Frame: Duration of simulation (15-20 minutes)

Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.

Secondary Outcomes

  • ISO 9241-400(Post-simulation (5 minutes))
  • Sytem Usability Scale (SUS)(Post-simulation (5 minutes))
  • Simulation Design Scale (SDS)(Post-simulation (5-10 minutes))
  • Learning effectiveness(5 months-post simulation (5 minutes))

Study Sites (1)

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