NCT06916949

Stress Evaluation and Management Using High Fidelity Simulation in Medical Education

The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to collect clinical and neurophysiological information to determine whether high-fidelity simulation can serve as a stress-inducing stimulus in a population of healthy residents (Emergency medicine, Anesthesia and Intensive care medicine, Paediatrics), both male and female, aged between 25 and 40 years. The main questions it aims to answer are: 1. Define in which phase of the simulation the highest level of stress is observed. 2. Determine the level of stress reached after performing a second high-fidelity simulation after a period of time. 3. Identify whether specific brain areas are activated during high-fidelity simulation. Participants will form teams, consisting of three medical trainees from the same specialty training program, that will undergo two high-fidelity simulations based on a clinical scenario relevant to their residency. * During the simulation, automatic pupillometry will be performed on all team members at the four time points. * Additionally, a two-lead ECG will be recorded for all team members at baseline and end of the debriefing * One team member will undergo EEG monitoring throughout the entire simulation. The EEG recordings will be sampled at baseline, during the simulation and end of the debriefing.

Conditions

• Stress
• Pupillometry
• High Fidelity Simulation Training
• Resident Education
• Heart Rate Variability, Biomarker of Stress
• Simulation Training

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electrocardiogram	two leads ECG
DIAGNOSTIC_TEST	Pupillometry	During the simulation, automatic pupillometry will be performed on all team members at the following time points: Baseline (T0) During the simulation (T1) End of the simulation (T2) End of the debriefing (T3)
DIAGNOSTIC_TEST	Electroencephalogram	EEG monitoring throughout the entire simulation. The EEG recordings will be sampled at: Baseline (T0) During the simulation (T1) End of the debriefing (T2)

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-04-01
• Completion: 2025-05-01
• First posted: 2025-04-08
• Last updated: 2025-04-08