[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586559":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":39,"locations":28,"responsibleParty":50,"collaborators":28,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":28,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":28,"overallStatus":77,"whyStopped":28,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":28},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15],"Diagnostic Test: Electrocardiogram","Diagnostic Test: Pupillometry","Diagnostic Test: Electroencephalogram",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","Electrocardiogram","two leads ECG",[9],[23],"ECG, EKG",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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)",[9],null,{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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)",[9],[34],"EEG",[36],{"name":37,"affiliation":5,"role":38},"Antonio Gullì","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Antonio Gulli', MD","CONTACT","3288647390","+39","antonio.gulli@policlinicogemelli.it",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Mariagiovanna Caporale, MD","3889844590","mariagiovanna.caporale@guest.policlinicogemelli.it",{"type":51,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100586559","stress-evaluation-and-management-using-high-fidelity-simulation-in-medical-education-100586559",false,"NCT06916949","Stress Evaluation and Management Using High Fidelity Simulation in Medical Education","The Role of High-fidelity Medical Simulation in Managing Emotional Components and Stress During Emergency and Urgent Care","STRATAGEM","Inclusion Criteria:\n\n* Medical trainees from the specialties of Emergency Medicine, Anesthesia and Intensive Care, Clinical Toxicology, Pediatrics, and Neonatology.\n* Normal hearing and vision, or corrected to normal.\n\nExclusion Criteria:\n\n* Known history of psychiatric disorders, cognitive impairment, or cardiac arrhythmias.\n* Current treatment with psychoactive, cardio-stimulant, or cardio-inhibitory medications.\n* Significant stressful life events in the past six months (e.g., family bereavement).\n* Previous systematic experience in meditation.",true,"ALL","25 Years","40 Years",{"count":65,"type":66},45,"ESTIMATED","INTERVENTIONAL",[69],"NA","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:\n\n1. Define in which phase of the simulation the highest level of stress is observed.\n2. Determine the level of stress reached after performing a second high-fidelity simulation after a period of time.\n3. Identify whether specific brain areas are activated during high-fidelity simulation.\n\nParticipants 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.\n\n* During the simulation, automatic pupillometry will be performed on all team members at the four time points.\n* Additionally, a two-lead ECG will be recorded for all team members at baseline and end of the debriefing\n* 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.",[72,25,73,74,75,76],"Stress","High Fidelity Simulation Training","Resident Education","Heart Rate Variability, Biomarker of Stress","Simulation Training","NOT_YET_RECRUITING","2025-04-01",{"date":80,"type":81},"2025-04-08","ACTUAL",{"date":83,"type":66},"2025-04",{"date":85,"type":66},"2025-05",{"name":5,"class":6}]