AR vs In Person Simulation for Medical Workplace Training

Augmented Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674188
• Other study ID #: 68663
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: March 22, 2023

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß blockers

Related Conditions & MeSH terms

• Augmented Reality

Intervention

Behavioral:
• Augmented Reality Headset
Augmented simulation of workplace-related scenarios of pre-recorded videos using the same actors

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasympathetic response indexed by RSA	Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.	Duration of simulation (15-20 minutes)
Secondary	Sytem Usability Scale (SUS)	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.	Post-simulation (5 minutes)
Secondary	ISO 9241-400	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.	Post-simulation (5 minutes)
Secondary	Simulation Design Scale (SDS)	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	Post-simulation (5-10 minutes)
Secondary	Learning effectiveness	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.	5 months-post simulation (5 minutes)