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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Simulation Training; Heart Rate Variability, Biomarker of Stress; High Fidelity Simulation Training; Resident Education; Pupillometry
• Intervention / Treatment: Diagnostic test: Electrocardiogram; Diagnostic test: Pupillometry; Diagnostic test: Electroencephalogram

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Gulli', MD; Phone Number: +39 3288647390; Email: antonio.gulli@policlinicogemelli.it
• Study Contact Backup: Name: Mariagiovanna Caporale, MD; Phone Number: +39 3889844590; Email: mariagiovanna.caporale@guest.policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Simulation team; 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.

Diagnostic test: Electrocardiogram; two leads ECG; Other Names: ECG, EKG; 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); Other Names: EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability (HRV) Analysis in the time domain	To assess whether stress levels vary during simulation phases. All subjects will undergo electrocardiographic (ECG) recording at baseline and at the end of the debriefing using a portable Holter ECG device. The ECG traces will then be extracted, artifact-cleaned, and converted for Heart Rate Variability (HRV) analysis using dedicated software. HRV is a measure of the variation in R-R intervals between consecutive heartbeats and reflects the extrinsic regulation of heart rate mediated by the autonomic nervous system on the sinoatrial node.	From the enrolment to two weeks after
Heart rate variability (HRV) analysis in the frequency domain	Low frequency (LF) reflects the simultaneous influence of both sympathetic and parasympathetic control on the sinoatrial node; and high frequency (HF) reflects parasympathetic nervous system modulation. The LF/HF ratio will be calculated as an indicator of the sympathovagal balance.	from the enrolment to two weeks after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.	The subjects undergo quantitative measurement of the pupillary light reflex at four time points: baseline, during simulation, at the end of the simulation, and at the end of the debriefing. The technique involves exposing both pupils of the subjects to an infrared light stimulus and assessing their reactivity parameters using an infrared sensor. The instrument used for data collection is the NPi-200 (NeurOptics, Irvine, CA, USA), a portable pupillometer that provides a light stimulus with fixed intensity (1000 lux) and duration (0.8s). We measure the Neurological Pupillary Index (NPI), a composite parameter, automatically derived, indicative of pupillary reactivity. An NPi ≥ 3 is considered normal.	From the enrolment to two weeks after
Identify brain areas involved during simulation using EEG	Identify whether specific brain areas are activated during high-fidelity simulation. One member from each simulation team (identified as the team leader) will undergo continuous electroencephalographic (EEG) monitoring using a 19-electrode device in fixed positions according to the international 10-20 system during three phases of the advanced medical simulation: Baseline stage during quiet wakefulness (eyes closed);; During the medical simulation;; During the debriefing. The EEG recordings will be transmitted to a computer and analyzed using the eLORETA software (exact Low Resolution Brain Electromagnetic Tomography), that allows connectivity analysis. The study of brain connectivity allows for the identification of statistically significant synchronization between signals recorded from two or more electrodes. Connectivity can be estimated as functional connectivity, which is bidirectional and does not determine a causal effect.	From the enrolment to two weeks after
Variation of stress level over time using Perceived Stress Scale 10	Determine the level of stress reached after performing a second high-fidelity simulation after a period of time. Assessment of Stress Level and Emotional Component through the completion of the Perceived Stress Scale 10 (PSS-10) by the medical trainee. This scale consists of ten items, with each item rated on a scale from 0 (not stressful at all) to 4 (very stressful), focusing on thoughts and emotions experienced over the past 30 days. A score between 0 and 13 indicates good emotional management in both personal and professional life. A score between 14 and 26 suggests initial difficulties in managing emotions and stress. A score between 27 and 40 indicates an excessive stress load that negatively affects the individual's well-being.	From the enrolment to two weeks after

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Antonio Gullì, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Estimated): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ID7328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Access Criteria: All researchers that wish to, can gain access to the IPD and supporting information by contacting the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No