[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596824":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":53,"collaborators":25,"id":55,"slug":25,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual reality","EXPERIMENTAL","Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia)",[13],"Device: Virtual reality",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","ACTIVE_COMPARATOR","Routine preoperative procedure (local anesthesia)",[19],"Procedure: Usual Care Group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Virtual reality hypnosis software applications are Class I medical devices according to Rule 12 of Directive 93\u002F42\u002FEC. They allow, through a virtual reality headset and headphones, to immerse the patient in a hypnotic sound and visual environment. Several visual scenarios can be proposed, allowing the patient to virtually travel to a beach, the seabed, on an alpine walk, etc.).\n\nThe HypnoVR Biofeedback virtual reality device is provided by the HypnoVR company.",[9],null,{"type":27,"name":28,"description":17,"armGroupLabels":29,"otherNames":25},"PROCEDURE","Usual Care Group",[15],[31],{"facility":32,"status":33,"city":34,"state":25,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Clinique Monticelli","RECRUITING","Marseille","13008","France","FR",{"type":39,"coordinates":40},"Point",[41,42],5.38107,43.29695,{"lat":42,"lon":41},[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Louis HOFFART, MD","CONTACT","04 91 16 22 22","33","louis.hoffart@me.com",{"name":46,"role":52,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100596824",false,"NCT07050498","Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery","ERVAN","Inclusion Criteria:\n\n* Patient aged 18 years or older,\n* Patient who has read and signed the consent form for participation in the study after a reflection period (between 10 and 45 minutes)\n* Patient who is a candidate for refractive surgery\n\nExclusion Criteria:\n\n* Contraindication to virtual reality (uncontrolled epilepsy, hearing impairment)\n* Pregnant or breastfeeding patient\n* Cushing's disease, Addison's disease, hypo- or hyperthyroidism\n* Patient treated with topical or systemic corticosteroids\n* Patient treated with neuroleptics, anxiolytics, or antidepressants\n* Patient under legal protection, guardianship, or curatorship\n* Patient participating in another blinded research study\n* Patient not affiliated with the French social security system\n* Patient unable to understand the information provided and\u002For give written informed consent: dementia, psychosis, impaired consciousness, non-French-speaking patient","ALL","18 Years",{"count":64,"type":65},68,"ESTIMATED","INTERVENTIONAL",[68],"NA","The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels.\n\nThe assessment of preoperative anxiety levels will be based on the administration of a psychometric scale (APAIS scale) and the measurement of salivary cortisol, which is a sensitive marker of the patient's stress level.",[71],"Refractive Disorders",[73],"refractive surgery","2025-06-24",{"date":76,"type":77},"2025-07-03","ACTUAL",{"date":79,"type":77},"2024-09-18",{"date":81,"type":65},"2026-09-18",{"name":5,"class":6},1]