- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376255
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
Conditions
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.
Sponsor
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
Keywords
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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