[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570206":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":18,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University Hospital Augsburg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (+ video googles)","EXPERIMENTAL","Patients undergoging surgery, video googles are used during surgery to reduce patient distress",[13],"Device: video googles",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (- video googles)","NO_INTERVENTION","Patients undergo surgery in the same way, no video googles or other devices for the reduction of distress is used",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","video googles","Patients undergoing surgery use video googles and a headphone to distract from surgery",[9],[26],"multimedial distraction",[28],{"name":29,"affiliation":30,"role":31},"Alexander Hyhlik-Dürr, Prof. Dr.","Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Hagen Kerndl","CONTACT","+49 821 400 2655","hagen.kerndl@uk-augsburg.de",{"name":39,"role":35,"phone":18,"phoneExt":18,"email":40},"Thomas Millian","thomas.millian@uk-augsburg.de",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Universitätsklinikum Augsburg","RECRUITING","Augsburg","Bavaria","86156","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],10.89851,48.37154,{"lat":54,"lon":53},[57,59,60],{"name":34,"role":35,"phone":58,"phoneExt":18,"email":37},"+49 821 40 2655",{"name":39,"role":35,"phone":18,"phoneExt":18,"email":18},{"name":34,"role":61,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[65],{"name":66,"class":67},"HappyMed GmbH (Wien, Austria)","UNKNOWN","100570206","stress-reduction-using-video-googles-on-patients-undergoing-vascular-surgery-100570206",false,"NCT06704230","Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery","Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia","MEP-VASC","Inclusion Criteria:\n\n* Planed carotid endarterectomy in local anesthesia\n\nExclusion Criteria:\n\n* patients which are not able to communicate because of stroke or language barrier,\n* Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery\n* medication with steroids","ALL","18 Years",{"count":79,"type":80},100,"ESTIMATED","INTERVENTIONAL",[83],"NA","One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia.\n\nIn many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.",[86,87,88],"Carotid Artery Diseases","Regional Anesthesia","Distress, Procedural",[22,90,91,92],"carotid endarterectomy","distress in patients","vascular surgery","2024-11-22",{"date":95,"type":96},"2024-11-26","ACTUAL",{"date":98,"type":96},"2022-09-09",{"date":100,"type":80},"2025-04",{"name":5,"class":6},1]