NCT06351397

Brief Summary

This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

January 24, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

April 1, 2024

Last Update Submit

January 17, 2026

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • Changes in self-reported empathy from before and after the simulation

    Measured with Jefferson Scale of Physician Empathy for physicians and other practicing health professionals (HP-Version). The survey contains 20 item with 7-point scale, 1 indicates strongly disagree and 7 indicates strongly agree (a higher number on the scale indicates more agreement).

    baseline, immediately after the intervention

Secondary Outcomes (3)

  • Satisfaction of Design Features of the Simulation

    immediately after the intervention

  • Evaluation of the CHARM system's usability

    immediately after simulation

  • Evaluation of the CHARM system's ergonomics

    immediately after simulation

Study Arms (2)

Mixed Reality Group

EXPERIMENTAL

In the MR group, the simulation instructor will explain the scope of the simulation embodiment experience and equip a weighted vest on the participant as they are asked to lay on a hospital patient gurney, seated upright. The participant, who is wearing a weighted vest to simulate an anterior mediastinal mass, will be asked to be seated upright and will view various holograms including vitals monitors, hear hospital related sounds via the headset, and also see additional holographic assets including intravenous polls and a defibrillator as well as experience heat (simulating a fever) from heat lamps. The simulation instructor will play the role of a physician who is using good communication skills based on the Calgary-Cambridge Guide to review a scripted consent for a high risk biopsy under sedation that may require life saving interventions such as extracorporeal membranous oxygenation (ECMO).

Behavioral: Mixed Reality (MR)

Control

ACTIVE COMPARATOR

In the control group, there will be no headset, no heat lamps, and no weighted vest and the participant will rely on their imagination to embody the teenager while lying in the simulation room bed while being consented for the same procedure as the MR group.

Behavioral: Control

Interventions

Mixed Reality simulation of medical crisis scenarios. MR 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

Mixed Reality Group
ControlBEHAVIORAL

Tradition simulation of medical crisis scenarios.

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • a history of severe motion sickness
  • currently have nausea
  • have a history of seizures
  • are uncomfortable wearing a \~7 pound weighted vest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94303, 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

April 1, 2024

First Posted

April 8, 2024

Study Start

January 24, 2025

Primary Completion

October 8, 2025

Study Completion

October 8, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations