[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516205":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":72,"collaborators":27,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":27,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":27,"enrollmentInfo":83,"targetDuration":27,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":27,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","This patient group received A standard form of patient education, consisting of oral information and an informative flyer during their outpatient clinic visit. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).\n\n1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.",[13,14],"Diagnostic Test: State Trait Anxiety Inventory","Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale",{"label":16,"type":17,"description":18,"interventionNames":19},"Intervention group - VR","EXPERIMENTAL","This patient group first received a standard form of patient education, consisting of oral information and an informative flyer. Additionally, patients watched a 360-degree VR Tour using a Pico G2 4K VR headset, describing their entire clinical pathway in more detail.\n\nAfter this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).\n\n1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again.",[20,13,14],"Behavioral: 360-degree Virtual Reality Patient Tour",[22,28,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","360-degree Virtual Reality Patient Tour","A 360-degree video that encompasses the entire clinical pathway. Patients are able to familiarize themselves with the hospital settings (nursery ward, operating room, intensive care unit).",[16],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIAGNOSTIC_TEST","State Trait Anxiety Inventory","Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.",[9,16],[34],"STAI",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Amsterdam Preoperative Anxiety and Information Scale","This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.",[9,16],[40],"APAIS",[42],{"name":43,"affiliation":44,"role":45},"Jolanda Kluin, MD, PhD","j.kluin@amsterdamumc.nl","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":27,"email":51},"Sulayman el Mathari, MD","CONTACT","+31628156982","s.elmathari@amsterdamumc.nl",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Academic Medical Center","RECRUITING","Amsterdam","North Holland","1105 AZ","Netherlands","NL",{"type":62,"coordinates":63},"Point",[64,65],4.88969,52.37403,{"lat":65,"lon":64},[68,71],{"name":69,"role":49,"phone":70,"phoneExt":27,"email":51},"Sulayman El Mathari, MD","+31 205668188",{"name":43,"role":45,"phone":27,"phoneExt":27,"email":27},{"type":45,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Jolanda Kluin","Professor of Cardiothoracic Surgery","100516205","the-effects-of-360-degree-virtual-reality-on-pre-procedural-anxiety-in-patients-awaiting-elective-cardiac-surgery-involving-a-sternotomy-100516205",false,"NCT06001489","The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy","Inclusion Criteria:\n\n* Patients awaiting elective cardiac surgery involving a sternotomy\n* 18 years or older\n\nExclusion Criteria:\n\n* Under the age of 18\n* History of previous cardiac surgery\n* (concomitant) aortic surgery\n* Cardiac surgery for congenital heart defects\n* Hearing or visual impairments\n* Language barriers (inability to understand, speak or read Dutch)\n* History of severe mental or psychiatric disorders","ALL","18 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet.\n\nObjective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education.\n\nStudy design: Single-center, randomized controlled trial\n\nStudy population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.",[91,92,93,94],"Cardiac Valve Disease","Aortic Valve Disease","Mitral Valve Disease","Tricuspid Valve Disease","2024-07-09",{"date":97,"type":98},"2024-07-10","ACTUAL",{"date":100,"type":98},"2023-07-01",{"date":102,"type":85},"2024-12",{"name":5,"class":6},1]