[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596870":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":33,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":93,"whyStopped":33,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Receives the MindfulGarden intervention in addition to routine post-operative management and standard delirium reduction measures.",[13],"Device: A novel device developed providing nature-driven responsive imagery that responds to the patient's physiological to distract, engage, and de-escalate behaviours of delirium.",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Participants will receive standard care, which includes routine post-operative care pathways for cardiac surgery, and standard delirium reduction measures.",[19],"Procedure: Routine post-operative management and standard delirium reduction measures.",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","A novel device developed providing nature-driven responsive imagery that responds to the patient's physiological to distract, engage, and de-escalate behaviours of delirium.","This device will be provided on top of routine post-operative management and standard delirium reduction measures. It has proven effective in a previous clinical trial by reducing agitation and unscheduled medications. It displays nature-driven responsive imagery through an available mobile screen\u002Fdevice for the first 7 days after surgery or discharge, whichever comes first. The imagery adapts in real-time to the participant's movement and sound. The device will be placed at the foot of the bed while the patient is awake and may be interrupted at the discretion of the patient, bedside RN or attending physician.",[9],[27],"MindfulGarden",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Routine post-operative management and standard delirium reduction measures.","Examples of routine post-operative care are sleep optimization, avoidance of delirium-promoting medications, orientation, and mobilization.",[15],null,[35],{"name":36,"affiliation":5,"role":37},"Alana Flexman, MD MBA","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Alana Flexman, MD","CONTACT","604-682-2344","62115","aflexman@providencehealth.bc.ca",[46],{"facility":47,"status":33,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"St. Paul's Hospital","Vancouver","British Columbia","V6Z 1Y6","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-123.11934,49.24966,{"lat":57,"lon":56},[60],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Alana Flexman","Clinical Associate Professor",[65],{"name":66,"class":6},"Canadian Anesthesiologists' Society","100596870","responsive-nature-driven-imagery-to-reduce-delirium-after-cardiac-surgery-100596870",false,"NCT07051096","Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery","Responsive Nature-Driven Imagery to Reduce Delirium After Cardiac Surgery: A Pilot Randomized Controlled Trial","RESPITE","Inclusion Criteria:\n\n* Planned open-heart cardiac surgery (e.g. coronary artery bypass grafting, valve replacement surgery);\n* Able to understand study procedures and provide informed consent in English;\n* At least one delirium risk factor: 1) Age less than 65yrs; 2) History of delirium; 3) History of stroke\u002FTIA; 4) Known cognitive impairment; 5) Depression requiring medication.\n\nExclusion Criteria:\n\n* Severe pre-existing cognitive impairment (Montreal Cognitive Assessment \\[MOCA6\\]\\\u003C10)\n* Uncorrected visual impairment;\n* Significant impairment from psychiatric disease;\n* Enrolment in another clinical trial which may interfere with the study outcome measures.","ALL","18 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn if a novel device (MindfulGarden) is beneficial in a population of patients undergoing cardiac surgery. The main questions it aims to answer are:\n\nIs a novel device (MindfulGarden) that uses responsive nature-driven imagery feasible in patients undergoing cardiac surgery? Will use of this device reduce the use of psychotropic medications, improve recovery experience, and improve delirium?\n\nParticipants will receive routine post-operative management and standard delirium reduction measures. They will be randomized into two groups where one receives the novel device (MindfulGarden) and the other does not.",[85,86,87,88],"Delirium - Postoperative","Agitation","Anxiety","Cardiac Surgery Recovery",[90,91,92,27],"Randomized trial","Delirium","Cardiac surgery","NOT_YET_RECRUITING","2025-06-26",{"date":96,"type":97},"2025-07-03","ACTUAL",{"date":99,"type":79},"2025-09",{"date":101,"type":79},"2027-01",{"name":5,"class":6},1]