Stress Evaluation and Management Using High Fidelity Simulation in Medical Education

NCT06916949 | Not Yet Recruiting

• 1 other identifier: ID7328
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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:

• 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry.

  From the enrolment to two weeks after

• Identify brain areas involved during simulation using EEG

  From the enrolment to two weeks after

• Variation of stress level over time using Perceived Stress Scale 10

  From the enrolment to two weeks after

Study Arms (1)

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.

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

Interventions

Electrocardiogram DIAGNOSTIC_TEST

two leads ECG

Also known as: ECG, EKG

Simulation team

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)

Simulation team

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)

Also known as: EEG

Simulation team

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (2)

• 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.

  PMID: 29723392 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.

  PMID: 15313543 BACKGROUND

MeSH Terms

Interventions

Electrocardiography; Electroencephalography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Diagnostic Techniques, Neurological

Study Officials

• Antonio Gullì

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Gulli', MD

CONTACT

3288647390; antonio.gulli@policlinicogemelli.it

Mariagiovanna Caporale, MD

CONTACT

3889844590; mariagiovanna.caporale@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: All researchers that wish to, can gain access to the IPD and supporting information by contacting the corresponding author