Virtual Reality vs Inperson Simulation: A Non-inferiority Study

NCT03863314 | Completed

• 1 other identifier: 48883
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Work-Related Condition

Keywords

Virtual Reality; Simulation; Workplace

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Skin conductance levels

  Throughout duration of simulation, approximately 15 minutes

• Emotional levels

  Throughout duration of intervention, two minutes before and after the intervention

• VR Simulation Questionnaire

  Three months post study, approximately 5 minutes

Study Arms (2)

In-Person Simulation

ACTIVE COMPARATOR

Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment

Other: In-person Simulation

Virtual Simulation

EXPERIMENTAL

Participants will experience virtual simulations of different workplace scenarios such as medical error and workplace harassment via Virtual Reality headset.

Device: Virtual Simulation

Interventions

Virtual Simulation DEVICE

Virtual simulation of workplace-related scenarios of pre-recorded videos using the same actors

Virtual Simulation

In-person Simulation OTHER

In-person simulation of workplace-related scenarios with live actors

In-Person Simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• Bernardo A. Virtual Reality and Simulation in Neurosurgical Training. World Neurosurg. 2017 Oct;106:1015-1029. doi: 10.1016/j.wneu.2017.06.140.

  PMID: 28985656 BACKGROUND

• 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.

  PMID: 30668519 BACKGROUND

• 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.

  PMID: 30678276 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 5, 2019
• Study Start: July 9, 2019
• Primary Completion: July 11, 2019
• Study Completion: November 15, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

US (1)