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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06351397
Other study ID # 75021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2025

Study information

Verified date April 2024
Source Stanford University
Contact Thomas Caruso, MD, PhD
Phone 6282750341
Email tjcaruso@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
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: - a history of severe motion sickness - currently have nausea - have a history of seizures - are uncomfortable wearing a ~7 pound weighted vest.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mixed Reality (MR)
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

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 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 Satisfaction of Design Features of the Simulation Measured by Simulation Design Scale. The simulation design scale consists of 20 items in total. In the first stage, in order to evaluate whether the items used in the simulation method were given in the best way for the participant, they were expressed as strongly disagree, disagree, undecided, agree, strongly agree. The survey contains 20 item with 5-point scale, 1 indicates strongly disagree and 5 indicates strongly agree (a higher number on the scale indicates more agreement).
In the second stage, there are statements that will determine the level of importance of the scale items for the participant, not important, partially important, undecided, important, very important. The survey contains 20 item with 5-point scale, 1 indicates not important and 5 indicates very important (a higher number on the scale indicates more important).
In the evaluation phase, the scale score is calculated by dividing the total and the total of the sub-dimensions by the number of items.
immediately after the intervention
Secondary Evaluation of the CHARM system's usability Measured by System Usability Scale (SUS). The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree) immediately after simulation
Secondary Evaluation of the CHARM system's ergonomics Measured by the ISO Ergonomic scale. The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree) immediately after simulation
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