Augmented Reality Medical Simulation

August 16, 2023 updated by: Thomas Caruso, Stanford University

Augmented Reality Medical Simulation: A Multi-Collaborative Study of Acceptance and Usability

In order to improve the quality of care we provide to patients, medical trainees need to experience low incident, high mortality events in a safe learning environment. There is a selection bias for predisposing characteristics of health care providers, as most people who have pursued a career in medicine are motivated to learn how to manage medical emergencies. Resources have been traditionally enabled with conventional simulation centers or mobile simulation units. However, these are costly and difficult to access. The purpose of this study is to evaluate a mixed reality alternative to conventional simulation. The need for this is inherent in becoming a medical provider and use of these resources will improve health practices and health services.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94303
        • Lucile Packard Children's Hospital Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
  • 18 years and older

Exclusion Criteria:

  • Have a history of severe motion sickness
  • Currently have nausea
  • History of seizures
  • Are clinically unstable
  • Currently using corrective glasses (not compatible with AR headset)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mixed Reality Simulation
Participants in the experimental arm will be introduced to workplace training modules through an Augmented Reality (AR) headset.
AR headset - a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Interview Assessment of Remote Simulations
Time Frame: Post-Simulation, Approximate time duration (3-5 minutes)
Primary Aim: The primary aim is to study the acceptance of AR simulation among anesthesia residents using the Technology Acceptance Model (TAM)
Post-Simulation, Approximate time duration (3-5 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS) Questionnaire
Time Frame: Post-Simulation, Approximate time duration (3-5 minutes)
The first secondary aim is to evaluate AR simulation usability via the System Usability Scale (SUS) and ISO 9241-400 Assessment of human-ergonomic factors.
Post-Simulation, Approximate time duration (3-5 minutes)
Ergonomic Survey
Time Frame: Post-Simulation, Approximate time duration (3-5 minutes)
: The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 Assessment of human-ergonomic factors.
Post-Simulation, Approximate time duration (3-5 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2020

Primary Completion (Estimated)

August 18, 2024

Study Completion (Estimated)

August 18, 2025

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 55657

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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