Stress Evaluation and Management Using High Fidelity Simulation in Medical Education (STRATAGEM)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: High Fidelity Simulation Training; Simulation Training; Resident Education; Heart Rate Variability, Biomarker of Stress; Pupillometry; Stress

Treatments: Diagnostic Test: Electroencephalogram; Diagnostic Test: Electrocardiogram; Diagnostic Test: Pupillometry

Study type: Interventional

Funder types: Other

Identifiers

NCT06916949

ID7328

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medical trainees from the specialties of Emergency Medicine, Anesthesia and Intensive Care, Clinical Toxicology, Pediatrics, and Neonatology.
• Normal hearing and vision, or corrected to normal.

Exclusion criteria

• Known history of psychiatric disorders, cognitive impairment, or cardiac arrhythmias.
• Current treatment with psychoactive, cardio-stimulant, or cardio-inhibitory medications.
• Significant stressful life events in the past six months (e.g., family bereavement).
• Previous systematic experience in meditation.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Simulation team

Experimental group

Description:

All participants will be divided in teams, each one consisting of three medical trainees from the same specialty training program, and all of them will undergo two high-fidelity simulations based on a clinical scenario relevant to their specialization.

Treatment:

Diagnostic Test: Pupillometry

Diagnostic Test: Electrocardiogram

Diagnostic Test: Electroencephalogram