[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599822":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":26,"locations":18,"responsibleParty":37,"collaborators":18,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":18,"enrollmentInfo":50,"targetDuration":18,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":18},{"fullName":5,"class":6},"Institut de Cancérologie de Lorraine","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"surgical trainees group","The study group consists of surgical trainees with limited experience in simulated surgery. They will perform multiple 15-minute surgical sequences in a controlled environment, where anesthesia alarm sound levels will vary between 64 and 75 dB(A). These sound levels will be randomized across the sequences to assess the impact of noise on their mental workload, concentration, and surgical performance.",[12],"Other: effects of sound",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"effects of sound","The surgical trainees will perform four 15-minute surgical sequences in a controlled environment, with varying sound levels (64, 67, 73, and 75 dB(A)) randomized across the sequences to assess the surgeons' responses.",[9],null,[20,23],{"name":21,"affiliation":5,"role":22},"Frédéric MARCHAL, Pr.","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":5,"role":25},"Nour Mammari Halabi, PhD.","STUDY_CHAIR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Jean-Louis JL MERLIN, PU.","CONTACT","+33383598307","8307","jl.merlin@nancy.unicancer.fr",{"name":34,"role":29,"phone":35,"phoneExt":18,"email":36},"Lydie LEMOINE","03 83 59 86 89","l.lemoine@nancy.unicancer.fr",{"type":38,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100599822","impact-of-anesthesia-alarm-volume-on-mental-workload-in-surgical-trainees-100599822",false,"NCT07089485","Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees","Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees: A Randomized Pilot Simulation Study","ASLEC02","Inclusion Criteria:\n\n* Surgical residents or experienced surgeons;\n* Surgeons with normal hearing;\n* Surgeons capable of performing surgical sutures (regardless of skill level);\n* Surgeons able and willing to follow all study procedures according to the protocol;\n* Surgeons who have understood, signed, and dated the informed consent form provided on the day of enrollment.\n\nExclusion Criteria:\n\n* Surgeons undergoing beta-blocker treatment;\n* Surgeons with known cardiac pathology;\n* Surgeons who do not consent to participate in the study;\n* Surgeons with known hearing problems;\n* Surgeons who fail the hearing test;\n* Surgeons who worked on-call or night shifts during the night before the evaluation day.\n* Surgical trainees at the Lorraine Cancer Institute.\n* Adults under legal protection (guardianship, curatorship, or legal supervision);Persons deprived of liberty;Pregnant or breastfeeding women.",true,"ALL","18 Years",{"count":51,"type":52},26,"ESTIMATED","INTERVENTIONAL",[55],"NA","Noise in hospital environments, particularly in operating rooms, poses challenges to both patient comfort and healthcare professionals' performance. Among the sources of noise, anesthesia monitoring alarms are essential for patient safety, yet no clear guidelines exist regarding their optimal sound level. Excessive alarm volume may increase distraction and cognitive load, especially for surgical trainees, potentially impairing their focus and performance during procedures. This randomized pilot interventional study aims to evaluate the impact of anesthesia alarm sound intensity on the mental workload of surgical trainees performing simulated surgeries. Participants will be randomly assigned to conditions with either an optimized alarm volume or a higher standard volume during simulated tasks. Cognitive load will be assessed using objective physiological measures such as heart rate variability and pupillometry, as well as subjective evaluations with tools like the NASA-TLX and SURG-TLX scales. The primary goal is to determine whether an optimized alarm sound level can reduce cognitive strain without compromising vigilance required for patient safety. Findings from this study are expected to provide evidence-based recommendations for auditory ergonomics in operating rooms, ultimately improving working conditions for surgical teams and enhancing both training and patient safety.",[58,59,60,61],"Surgical Procedures","Noise","Hearing Disorder","Mental Workload",[63,64,65],"Noise\u002Fadverse effects","Cognition Disorders","Surgical procedures","NOT_YET_RECRUITING","2025-09-22",{"date":69,"type":70},"2025-09-25","ACTUAL",{"date":69,"type":52},{"date":73,"type":52},"2026-09-26",{"name":5,"class":6}]