Traditional In-Person Vs. Remote AR Clinical Simulation (AR Brazil)

July 18, 2025 updated by: Thomas Caruso, Stanford University

Remote Augmented Reality Versus Traditional In-person Resuscitation Assessment: an International Noninferiority Randomized Controlled Trial

This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

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

  • United States
    • California
      • Stanford, California, United States, 94304
        • Lucile Parkard Children's Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Brazilian resident

Exclusion Criteria:

  • a history of severe motion sickness
  • currently have nausea
  • a history of seizures
  • wear corrective glasses.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Augmented Reality Enhanced Simulation (Treatment group)
Participants will experience augmented simulations with a holographic mixed-reality setting based on different workplace scenarios such as medical crisis via Augmented Reality (AR) headset.
Behavioral: Augmented Reality simulation
Augmented simulation of medical crisis scenarios
Active Comparator: Traditional In Situ Simulation (Control group)
Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment
Behavioral: In Person simulation
In Person simulation of medical crisis scenarios

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Technical Skill (TS) and Non Technical Skill (NTS) Performance
Time Frame: immediately after simulation
Measured with Instrument for the evaluation of advanced life support performance. The instrument consists of 26 items, which are rated on a scale from +2 to -2. A total assessment score of performance is given based on a scale from 0 to 10 (0=poor, 10=excellent) at the end of the instrument.
immediately after simulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the AR system's usability
Time Frame: immediately after simulation
Measured with the System Usability Scale (SUS). The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
immediately after simulation
Evaluation of the AR system's ergonomics
Time Frame: immediately after simulation
Measured with the ISO 9241-400 Assessment of human-ergonomic factors. The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
immediately after simulation
Reassessment of Non Technical Skill (NTS) with Behaviorally Anchored Rating Scale (BARS)
Time Frame: immediately after simulation
Measured with individual Behaviorally Anchored Rating Scale (BARS). The BARS scoring system uses four categories assessing situation awareness, decision-making, communication and teamwork. The score ranges from 1 and 9 (1 = poor and 9 = excellent)
immediately after simulation

Collaborators and Investigators

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

Sponsor

Stanford University

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)

June 22, 2024

Primary Completion (Actual)

August 3, 2024

Study Completion (Actual)

August 3, 2024

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 74626

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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