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OpenTrials
Completed

NCT Number: NCT05674188

AR vs In Person Simulation for Medical Workplace Training

This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. One group will wear an AR headset and participate in an AR medical crisis scenario and the other group will participate in the same scenario with a traditional, mannequin based in situ simulation.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included

Exclusion criteria

  • Participants with reported severe motion sickness
  • Nausea
  • Seizure disorder
  • Currently using chronotropic heart medications, such as β blockers

Treatment and study plan

Augmented Reality Headset

Behavioral

Augmented simulation of workplace-related scenarios of pre-recorded videos using the same actors

Primary outcomes

  1. Parasympathetic response indexed by RSA

    Time frame: Duration of simulation (15-20 minutes)

    Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.

Secondary outcomes

  1. Sytem Usability Scale (SUS)

    Time frame: Post-simulation (5 minutes)

    10-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to measure usability. Only administered to the AR group.

  2. ISO 9241-400

    Time frame: Post-simulation (5 minutes)

    6-item ergonomic questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale only administered to the AR group.

  3. Simulation Design Scale (SDS)

    Time frame: Post-simulation (5-10 minutes)

    20-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to assess user satisfaction

  4. Learning effectiveness

    Time frame: 5 months-post simulation (5 minutes)

    Five months post-simulation, an assessment was sent out to participants with a 10-item, multiple choice with questions related to key learning points about resuscitation management.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

The Physiologic and Emotional Effects of Augmented Reality Simulation Versus In Person Simulation - A Noninferiority, Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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