Stress Evaluation and Management Using High Fidelity Simulation in Medical Education
NCT ID: NCT06916949
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2025-04-30
2025-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Electrocardiogram
two leads ECG
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)
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)
Interventions
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Electrocardiogram
two leads ECG
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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal hearing and vision, or corrected to normal.
Exclusion Criteria
* 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.
25 Years
40 Years
ALL
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Antonio Gullì
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Contacts
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References
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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.
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.
Other Identifiers
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ID7328
Identifier Type: -
Identifier Source: org_study_id
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