[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590025":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":53,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Belfast Health and Social Care Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality","EXPERIMENTAL",null,[13],"Procedure: Virtual Reality",{"label":15,"type":16,"description":17,"interventionNames":11},"Control","NO_INTERVENTION","Standard Care",[19],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"PROCEDURE","* VR\n* Spinal anaesthesia\n* Limited propofol aiming for OAA\u002FS of 4-5 (light sedation)",[9],[24],{"name":25,"affiliation":5,"role":26},"David Johnston","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Nicola Gallagher","CONTACT","02895043746","nicola.gallagher@belfasttrust.hscni.net",[34],{"facility":35,"status":36,"city":37,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Musgrave Park Hospital","RECRUITING","Belfast","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-5.92541,54.59682,{"lat":44,"lon":43},[47,48,52],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"name":49,"role":30,"phone":50,"phoneExt":11,"email":51},"Janet Hill","02895046799","janet.hill@belfasttrust.hscni.net",{"name":25,"role":26,"phone":11,"phoneExt":11,"email":11},{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100590025","can-the-use-of-virtual-reality-improve-tka-outcomes-100590025",false,"NCT06962046","Can the Use of Virtual Reality Improve TKA Outcomes","Can the Use of Virtual Reality Improve Outcomes Following Total Knee Arthroplasty With Spinal Anaesthesia? - A Pilot Study","VR-TKA","Inclusion Criteria:\n\n* Patients ≥ 18 years old who are American Society of Anaesthesiologists (ASA) grade 1 or 2 scheduled for routine primary elective knee arthroplasty.\n\nExclusion Criteria:\n\n* Patients who are ASA grade 3 or 4.\n* Patients who cannot use VR e.g. those with dementia.\n* Patients with an existing diagnosis of delirium.\n* Patients with visual impairment if degree of myopia\u002Fhyperopia exceeds the corrective power of the VR headset.\n* Patients with hearing aids.\n* Patients with previous history of motion sickness.\n* Patients with epilepsy, history of black outs or fitting.\n* Patients who will have an operation over 1 hour in duration or any patient who requires more complex surgery.\n* Patients who have requested no sedation during the operation.\n* Patients who have received premedication.\n* Patients who have a general anaesthetic.\n* Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs.\n* Patients who are not capable of informed consent.","ALL","18 Years","100 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"NA","Virtual reality (VR) uses computer technology to create a three-dimensional environment which the user can explore and interact with. VR can be used to distract the patient during an operation and has been used to avoid sedative premedication, increase patient satisfaction and decrease pain during nerve blocks. VR used alongside spinal anaesthetic for hip, knee and ankle operations has shown a trend of less sedation being required with no decrease in patient satisfaction.\n\nThe most common type of anaesthesia given during total knee arthroplasty (TKA) is spinal. Spinal anaesthesia is given unless there are complications or other conditions present, and general anaesthesia is given instead. General anaesthesia puts the patient to sleep during the operation, whereas spinal anaesthesia allows the patient to stay awake, but numbs the lower half of the body so no pain is felt. Sedation is usually given with spinal anaesthesia to make the patient relaxed and sleepy. Light sedation will allow the patient to be awake but relaxed, whereas deeper sedation means the patient is more likely to be asleep and less likely to recall what happened during the operation. Sedation can cause a number of side effects including nausea, vomiting, headache, drowsiness, pain, confusion, memory loss and breathing difficulties.\n\nIn this study, all patients will receive spinal anaesthesia. Group 1 will receive VR and a light level of sedation, whilst Group 2 will not receive VR but will receive a deeper level of sedation (standard of care). When using VR during TKA, a lighter level of sedation should be required. This could help to reduce side effects and aid quicker patient recovery. This pilot study aims to investigate this further.",[74],"Total Knee Arthroplasty","2025-04-29",{"date":77,"type":78},"2025-05-08","ACTUAL",{"date":80,"type":78},"2024-10-16",{"date":82,"type":68},"2025-12",{"name":5,"class":6},1]