Stress Evaluation and Management Using High Fidelity Simulation in Medical Education

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06916949
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-11
• Study Start: 2025-04
• Primary Completion: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability (HRV) Analysis in the time domain	From the enrolment to two weeks after	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.
Heart rate variability (HRV) analysis in the frequency domain	from the enrolment to two weeks after	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.

Secondary Outcome Measures

Name	Time	Method
Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.	From the enrolment to two weeks after	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.
Identify brain areas involved during simulation using EEG	From the enrolment to two weeks after	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.
Variation of stress level over time using Perceived Stress Scale 10	From the enrolment to two weeks after	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.