NCT05686590

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

4 days

First QC Date

January 6, 2023

Last Update Submit

December 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thematic Analysis of Post-Simulation Discussions

    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.

    Duration of post-simulation debrief (15-20 minutes)

Secondary Outcomes (2)

  • System Usability Scale (SUS)

    Duration of Intervention (less than one hour)

  • Headset Ergonomics

    Duration of Intervention (less than one hour)

Study Arms (1)

Augmented Reality Enhanced Simulation (Treatment group)

EXPERIMENTAL

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.

Behavioral: Augmented Reality Headset

Interventions

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.

Augmented Reality Enhanced Simulation (Treatment group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trainees/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
  • years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mountain View Fire Department

Mountain View, California, 94041, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

HypoglycemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 17, 2023

Study Start

December 12, 2022

Primary Completion

December 16, 2022

Study Completion

December 16, 2022

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations