Clinical trial NCT06916949: Stress Evaluation and Management Using High Fidelity Simulation in Medical Education
Official title: The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Pupillometry
High Fidelity Simulation Training
Resident Education
Heart Rate Variability, Biomarker of Stress
Simulation Training
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Heart Rate Variability (HRV) Analysis in the time domain
timeFrame: From the enrolment to two weeks after
measure: Heart rate variability (HRV) analysis in the frequency domain
timeFrame: from the enrolment to two weeks after
Secondary outcomes:
measure: Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.
timeFrame: From the enrolment to two weeks after
measure: Identify brain areas involved during simulation using EEG
timeFrame: From the enrolment to two weeks after
measure: Variation of stress level over time using Perceived Stress Scale 10
timeFrame: From the enrolment to two weeks after
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Antonio Gullì
role: PRINCIPAL_INVESTIGATOR
References:
citation: Champeroux P, Fesler P, Jude S, Richard S, Le Guennec JY, Thireau J. High-frequency autonomic modulation: a new model for analysis of autonomic cardiac control. Br J Pharmacol. 2018 Aug;175(15):3131-3143. doi: 10.1111/bph.14354. Epub 2018 Jun 15.
citation: Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.