Stress Evaluation and Management Using High Fidelity Simulation in Medical Education
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrocardiogram, Pupillometry, Electroencephalogram.
- Who it may be relevant to
- Registry conditions: Stress, Pupillometry, High Fidelity Simulation Training, Resident Education. Basic parameters: 25 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care
Overview
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.
Interventions
- Diagnostic test Electrocardiogram
two leads ECG - 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)
Primary outcome measures
- Heart Rate Variability (HRV) Analysis in the time domain [Time frame: From the enrolment to two weeks after]
- Heart rate variability (HRV) analysis in the frequency domain [Time frame: from the enrolment to two weeks after]
Secondary outcome measures (3)
- Changes in autonomic parameters in response to stress induced by high-fidelity simulation: automatic pupillometry. [Time frame: From the enrolment to two weeks after]
- Identify brain areas involved during simulation using EEG [Time frame: From the enrolment to two weeks after]
- Variation of stress level over time using Perceived Stress Scale 10 [Time frame: From the enrolment to two weeks after]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
Identifiers
NCT: NCT06916949 · ID7328