Virtual Reality vs Inperson Simulation: A Non-inferiority Study

Study Overview
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Brief Summary
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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).

Official Title
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Virtual Reality vs Inperson Simulation: A Non-inferiority Study

Conditions
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Work-Related Condition

Intervention / Treatment
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* Device: Virtual Simulation
* Other: In-person Simulation


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-Person Simulation<br>Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment | Other: In-person Simulation<br>* In-person simulation of workplace-related scenarios with live actors<br>|
| Experimental: Virtual Simulation<br>Participants will experience virtual simulations of different workplace scenarios such as medical error and workplace harassment via Virtual Reality headset. | Device: Virtual Simulation<br>* Virtual simulation of workplace-related scenarios of pre-recorded videos using the same actors<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin conductance levels | Skin conductance levels as measured by electrodermal activity will be collected using biometric sensors throughout either in-person or virtual simulation | Throughout duration of simulation, approximately 15 minutes | 
| Emotional levels | Emotional affect will be self reported via validated scale before and after the intervention. | Throughout duration of intervention, two minutes before and after the intervention | 
| VR Simulation Questionnaire | 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? | Three months post study, approximately 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Simulation, Workplace