[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442065":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":32,"centralContacts":47,"locations":57,"responsibleParty":76,"collaborators":32,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":32,"enrollmentInfo":88,"targetDuration":32,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":60,"whyStopped":32,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Heart and Brain Research Group, Germany","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Relaxation intervention with natural sounds","EXPERIMENTAL","The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.",[13],"Device: Intervention with natural sounds administered via headphones",{"label":15,"type":10,"description":16,"interventionNames":17},"Relaxation intervention with natural sounds and binaural beats","The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds and binaural beats.",[18],"Device: Intervention with natural sounds and binaural beats administered via headphones",{"label":20,"type":10,"description":21,"interventionNames":22},"Relaxation intervention with natural sounds and virtual reality","The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with a nature scene in a spherical 360° environment with associated nature sounds.",[23],"Device: Intervention with natural sounds and virtual reality administered via headphones and head mounted display",{"label":25,"type":10,"description":26,"interventionNames":27},"Relaxation intervention with natural sounds, binaural beats and virtual reality","The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with a nature scene in a spherical 360° environment with associated nature sounds and binaural beats.",[28],"Device: Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display",{"label":30,"type":31,"description":32,"interventionNames":32},"Control without Intervention","NO_INTERVENTION",null,[34,38,41,44],{"type":35,"name":36,"description":11,"armGroupLabels":37,"otherNames":32},"DEVICE","Intervention with natural sounds administered via headphones",[9],{"type":35,"name":39,"description":16,"armGroupLabels":40,"otherNames":32},"Intervention with natural sounds and binaural beats administered via headphones",[15],{"type":35,"name":42,"description":21,"armGroupLabels":43,"otherNames":32},"Intervention with natural sounds and virtual reality administered via headphones and head mounted display",[20],{"type":35,"name":45,"description":26,"armGroupLabels":46,"otherNames":32},"Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display",[25],[48,53],{"name":49,"role":50,"phone":51,"phoneExt":32,"email":52},"Rolf Meyer, M.Sc.-Psych.","CONTACT","+496032 996 2557","r.meyer@kerckhoff-klinik.de",{"name":54,"role":50,"phone":55,"phoneExt":32,"email":56},"Marius Butz, Dipl.-Psych.","+496032 996 5812","m.butz@kerckhoff-klinik.de",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Kerckhoff Heart Center, Heart and Brain Research Group","RECRUITING","Bad Nauheim","Hesse","61231","Germany","DE",{"type":67,"coordinates":68},"Point",[69,70],8.73859,50.36463,{"lat":70,"lon":69},[73,74],{"name":54,"role":50,"phone":32,"phoneExt":32,"email":56},{"name":75,"role":50,"phone":32,"phoneExt":32,"email":52},"Rolf Meyer, M.Sc.",{"type":77,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100442065","decreasing-preoperative-stress-to-prevent-postoperative-delirium-and-postoperative-cognitive-decline-in-cardiac-surgical-patients-100442065",false,"NCT05036538","Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.","Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Relaxation Interventions Via Virtual Reality and Binaural Beats.","DESTRESS-SURG","Inclusion Criteria:\n\n1. Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement\u002Freconstruction, or combination surgery) with standardized extracorporeal circulation.\n2. A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent.\n\nExclusion Criteria:\n\n1. History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation.\n2. Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy),\n3. Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli.\n4. Taking sedatives on the day of surgery.\n5. Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons.\n6. Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team.\n7. Participation in an interventional study according to AMG\u002FMPG will also be excluded.\n8. Patients with missing informed consent.","ALL","18 Years",{"count":89,"type":90},125,"ESTIMATED","INTERVENTIONAL",[93],"NA","Patients undergoing cardiac surgery often complain of anxiety before a major operation and the resulting stress. This circumstance is a risk factor for mental problems that may occur after the operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.",[96,97,98],"Preoperative Stress","Postoperative Cognitive Dysfunction","Postoperative Delirium",[100,101,98,96,102,103,104],"Cardiac Surgery","Postoperative Cognitive Decline","Relaxation Intervention","Virtual Reality","Binaural Beats","2026-02-13",{"date":107,"type":108},"2026-02-17","ACTUAL",{"date":110,"type":108},"2023-07-27",{"date":112,"type":90},"2028-11",{"name":5,"class":6},1]