Clinical Trial

Stress Evaluation and Management Using High Fidelity Simulation in Medical Education

Study acronym: STRATAGEM
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT06916949
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Stress, Pupillometry, High Fidelity Simulation Training, Resident Education, Heart Rate Variability, Biomarker of Stress, Simulation Training
Enrollment 45 participants
Start Date 2025-04
Primary Completion 2025-04 (estimated)
Study Completion 2025-05 (estimated)
Updated on ClinicalTrials.gov 2025-04-08