Virtual Reality vs Inperson Simulation: A Non-inferiority Study

• ClinicalTrials.gov Identifier: NCT03863314
• Recruitment Status: Completed
• First Posted: March 5, 2019
• Last Update Posted: April 13, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Thomas Caruso, Stanford University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Work-Related Condition	Device: Virtual Simulation; Other: In-person Simulation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Virtual Reality vs Inperson Simulation: A Non-inferiority Study
• Actual Study Start Date: July 9, 2019
• Actual Primary Completion Date: July 11, 2019
• Actual Study Completion Date: November 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Respiratory sinus arrhythmia [ Time Frame: 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 :

1. Skin conductance levels [ Time Frame: 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
2. Emotional levels [ Time Frame: 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.
3. VR Simulation Questionnaire [ Time Frame: 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?"

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States, 94304

Sponsors and Collaborators

Stanford University

More Information

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. Review.

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). pii: E451. doi: 10.3390/s19030451.

• Responsible Party: Thomas Caruso, Clinical Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03863314
• Other Study ID Numbers: 48883
• First Posted: March 5, 2019
• Last Update Posted: April 13, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Caruso, Stanford University:

Virtual Reality; Simulation; Workplace