Augmented Reality Medical Simulation

Educational Problems Clinical Trial

Official title:

Augmented Reality Medical Simulation: A Multi-Collaborative Study of Acceptance and Usability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04376255
• Other study ID #: 55657
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: August 18, 2025

Study information

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

Clinical Trial Summary

In order to improve the quality of care we provide to patients, medical trainees need to experience low incident, high mortality events in a safe learning environment. There is a selection bias for predisposing characteristics of health care providers, as most people who have pursued a career in medicine are motivated to learn how to manage medical emergencies. Resources have been traditionally enabled with conventional simulation centers or mobile simulation units. However, these are costly and difficult to access. The purpose of this study is to evaluate a mixed reality alternative to conventional simulation. The need for this is inherent in becoming a medical provider and use of these resources will improve health practices and health services.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 18, 2025
• Est. primary completion date: August 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
• 18 years and older

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Educational Problems

Intervention

Other:
• Augmented Reality (AR)
AR headset - 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

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	Qualitative Interview Assessment of Remote Simulations	Primary Aim: The primary aim is to study the acceptance of AR simulation among anesthesia residents using the Technology Acceptance Model (TAM)	Post-Simulation, Approximate time duration (3-5 minutes)
Secondary	System Usability Scale (SUS) Questionnaire	The first secondary aim is to evaluate AR simulation usability via the System Usability Scale (SUS) and ISO 9241-400 Assessment of human-ergonomic factors.	Post-Simulation, Approximate time duration (3-5 minutes)
Secondary	Ergonomic Survey	: The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 Assessment of human-ergonomic factors.	Post-Simulation, Approximate time duration (3-5 minutes)