Virtual Reality vs Inperson Simulation: A Non-inferiority Study

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).

Study Overview

• Status: Completed
• Conditions: Work-Related Condition
• Intervention / Treatment: Other: In-person Simulation; Device: Virtual Simulation

• Study Type: Interventional
• Enrollment (Actual): 120
• 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
• Genders Eligible for Study: All

Description

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

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
Active Comparator: In-Person Simulation; Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment	Other: In-person Simulation; In-person simulation of workplace-related scenarios with live actors
Experimental: Virtual Simulation; Participants will experience virtual simulations of different workplace scenarios such as medical error and workplace harassment via Virtual Reality headset.	Device: Virtual Simulation; Virtual simulation of workplace-related scenarios of pre-recorded videos using the same actors

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Bernardo A. Virtual Reality and Simulation in Neurosurgical Training. World Neurosurg. 2017 Oct;106:1015-1029. doi: 10.1016/j.wneu.2017.06.140.
• Kyaw BM, Saxena N, Posadzki P, Vseteckova J, Nikolaou CK, George PP, Divakar U, Masiello I, Kononowicz AA, Zary N, Tudor Car L. Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Jan 22;21(1):e12959. doi: 10.2196/12959.
• Fan YC, Wen CY. A Virtual Reality Soldier Simulator with Body Area Networks for Team Training. Sensors (Basel). 2019 Jan 22;19(3):451. doi: 10.3390/s19030451.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Virtual Reality; Workplace; Simulation
• Other Study ID Numbers: 48883

Drug and device information, study documents

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