Virtual Reality vs Inperson Simulation: A Non-inferiority Study

Work-Related Condition Clinical Trial

Official title:

Virtual Reality vs Inperson Simulation: A Non-inferiority Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863314
• Other study ID #: 48883
• Status: Completed
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: April 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 15, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Work-Related Condition

Intervention

Device:
• Virtual Simulation
Virtual simulation of workplace-related scenarios of pre-recorded videos using the same actors

Other:
• In-person Simulation
In-person simulation of workplace-related scenarios with live actors

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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