NCT06326450

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 22, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2024

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

March 15, 2024

Last Update Submit

July 18, 2025

Conditions

Keywords

Augmented RealityAdvanced Cardiac Life SupportClinical SimulationMedical Education

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Technical Skill (TS) and Non Technical Skill (NTS) Performance

    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 Outcomes (3)

  • Reassessment of Non Technical Skill (NTS) with Behaviorally Anchored Rating Scale (BARS)

    immediately after simulation

  • Evaluation of the AR system's usability

    immediately after simulation

  • Evaluation of the AR system's ergonomics

    immediately after simulation

Study Arms (2)

Experimental: Augmented Reality Enhanced Simulation (Treatment group)

EXPERIMENTAL

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

Traditional In Situ Simulation (Control group)

ACTIVE COMPARATOR

Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment

Behavioral: In Person simulation

Interventions

Augmented simulation of medical crisis scenarios

Experimental: Augmented Reality Enhanced Simulation (Treatment group)

In Person simulation of medical crisis scenarios

Traditional In Situ Simulation (Control group)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Brazilian resident

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Parkard Children's Hospital

Stanford, California, 94304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 22, 2024

Study Start

June 22, 2024

Primary Completion

August 3, 2024

Study Completion

August 3, 2024

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations