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OpenTrials
Completed

NCT Number: NCT03863314

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).

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Key information

Conditions

Work-Related Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Simulation

Device

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

In-person Simulation

Other

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

Primary outcomes

  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 outcomes

  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?"

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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