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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation team | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram | Diagnostic Test | two leads ECG |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Gulli', MD | Contact | 3288647390 | +39 | antonio.gulli@policlinicogemelli.it |
| Mariagiovanna Caporale, MD | Contact | 3889844590 | +39 | mariagiovanna.caporale@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Gullì | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29723392 | Background | 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. | |
| 15313543 | Background | 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. |
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All IPD collected throughout the trial
Beginning 3 months and ending 3 years after the publication of results
All researchers that wish to, can gain access to the IPD and supporting information by contacting the corresponding author
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| Pupillometry | Diagnostic Test | 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) |
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| Electroencephalogram | Diagnostic Test | EEG monitoring throughout the entire simulation. The EEG recordings will be sampled at: Baseline (T0) During the simulation (T1) End of the debriefing (T2) |
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| 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:
| 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 |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D003943 | Diagnostic Techniques, Neurological |
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