- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05686590
Prehospital Provider Training With Augmented Reality (AR)
February 14, 2024 updated by: Thomas Caruso
Prehospital Provider Training Using Augmented Reality Simulation: A Mixed-Methods Study
The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers.
The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
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
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California
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Mountain View, California, United States, 94041
- Mountain View Fire Department
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Palo Alto, California, United States, 94305
- Lucile Packard Children's Hospital at Stanford
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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/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
- 18 years and older
Exclusion Criteria:
- Participants who do not consent
- 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)
- Currently pregnant
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Augmented Reality Enhanced Simulation (Treatment group)
Each simulation will have between two and five participants.
After consent, demographic data will be collected.
Then, a study RA will fit a Magic Leap One (ML1) headsets (Magic Leap Inc., Plantation, FL) to participants.
Following a scripted briefing, the instructor will also orient the participants to the ML1 headset for those in that group.
After orienting the participant to the use of the headsets, the instructor will remain in a room separate from the participants, who will conduct the scenario outside.
This will enable assessment of the feasibility of providing simulation instruction remotely.
Prior to starting the scenario, the simulation instructor will conduct an orientation to review the core tenets of effective communication skills during prehospital care.
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The simulation scenario will be a pediatric hypoglycemia-induced seizure case, which will be done through an AR simulation.
AR (Augmented Reality) headset, which is 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thematic Analysis of Post-Simulation Discussions
Time Frame: Duration of post-simulation debrief (15-20 minutes)
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The primary aim is to study the acceptance of AR simulation amongst prehospital providers via thematic analysis of semi-structured discussions using qualitative research methods.
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Duration of post-simulation debrief (15-20 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Usability Scale (SUS)
Time Frame: Duration of Intervention (less than one hour)
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The first secondary aim is to evaluate AR simulation usability amongst prehospital providers via the System Usability Scale (SUS).
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Duration of Intervention (less than one hour)
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Headset Ergonomics
Time Frame: Duration of Intervention (less than one hour)
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The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 assessment of human-ergonomic factors.
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Duration of Intervention (less than one hour)
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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)
December 12, 2022
Primary Completion (Estimated)
December 13, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
January 6, 2023
First Submitted That Met QC Criteria
January 6, 2023
First Posted (Actual)
January 17, 2023
Study Record Updates
Last Update Posted (Estimated)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67544
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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