Virtual Reality vs Inperson Simulation: A Non-inferiority Study

Not Applicable

Completed

• Conditions: Work-Related Condition
• Interventions: Other: In-person Simulation; Device: Virtual Simulation

• Registration Number: NCT03863314
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to determine if Virtual Reality (VR) can elicit emotional responses that are captured via physiological biometrics such as heart rate variability and skin conductance levels. As a non-inferiority study the investigators anticipate the technologies will elicit an emotional not inferior to those responses of an in-person simulations of workplace scenarios (i.e medical error and workplace harassment).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-07-09
• Primary Completion: 2019-07-11
• Study Completion: 2019-11-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Greater than 18 years of age
• Personnel working or volunteering at Lucile Packard Children's Hospital (LPCH) or Stanford Health Care (SHC) facilities

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Exclusion Criteria

• Patients who do not consent
• Are currently taking beta blockers or other chronotropic heart medication(s)
• Have a history of severe motion sickness
• Currently have nausea
• Currently experiencing seizures
• Are clinically unstable

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Person Simulation	In-person Simulation	Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment
Virtual Simulation	Virtual Simulation	Participants will experience virtual simulations of different workplace scenarios such as medical error and workplace harassment via Virtual Reality headset.

Primary Outcome Measures

Name	Time	Method
Respiratory sinus arrhythmia	Throughout duration of simulation, approximately 15 minutes	Biometric sensors will be placed in strategic locations in order to collect respiratory sinus arrhythmia throughout either in-person or virtual simulation

Secondary Outcome Measures

Name	Time	Method
Emotional levels	Throughout duration of intervention, two minutes before and after the intervention	Emotional affect will be self reported via validated scale before and after the intervention.
Skin conductance levels	Throughout duration of simulation, approximately 15 minutes	Skin conductance levels as measured by electrodermal activity will be collected using biometric sensors throughout either in-person or virtual simulation
VR Simulation Questionnaire	Three months post study, approximately 5 minutes	Participants will be given a questionnaire regarding their virtual or in-person simulation experience and the overall similarity to real-life on a scale from 1-5 (1=Completely Different and 5=Nearly Identical) Example Questions: "How true to real life were the emotions expressed during the scenario?" and "How true to real life was the the clinical environment?"

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States