[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659961":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":56,"studyPopulation":48,"armGroups":57,"interventions":68,"overallOfficials":48,"centralContacts":84,"locations":94,"responsibleParty":111,"collaborators":113,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":48,"enrollmentInfo":127,"targetDuration":48,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":139,"overallStatus":97,"whyStopped":48,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"NHS Highland Research, Development and Innovation Organisation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":41},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Percentage of patients who refuse to participate in the study","This will be measured as a percentage of the total number of potential participants approached. This figure should not be greater than 70%.","From 10 days pre surgery to 90 days post surgery",{"measure":14,"description":15,"timeFrame":12},"Percentage of participants with complete questionnaires","This will be measured as a percentage of the total number of participants recruited. This figure should be greater than 80%.",{"measure":17,"description":18,"timeFrame":19},"Participant VR Headset Use Compliance Rate","This will be measured by recording the number of days the VR headset is used for 20 minutes per day over 37 days.\n\n(These compliance rates will be measured by data which is recorded by the VR headset itself).","From 7 days pre surgery to 30 days post surgery",[21,24,27,30,34,38],{"measure":22,"description":23,"timeFrame":12},"Number of patients approached for the study","Total number of potential participants approached to join the study",{"measure":25,"description":26,"timeFrame":12},"Number of participants recruited overall","Total number of participants recruited to the study",{"measure":28,"description":29,"timeFrame":12},"Percentage of patients excluded overall","This will be measured as a percentage of the total number of potential participants approached.",{"measure":31,"description":32,"timeFrame":33},"Participant VR Headset Use Compliance Rate - Pre Operative","This will be measured by recording the participant's use of the VR headset during the pre-operative period (number of days VR headset is used for 20 minutes per day over 7 days)\n\n(These compliance rates will be measured by data which is recorded by the VR headset itself)","For 7 days pre day of surgery",{"measure":35,"description":36,"timeFrame":37},"Participant VR Headset Use Compliance Rate - Post Operative","This will be measured by recording the participant's use of the VR headset during the post-operative period (number of days VR headset is used for 20 minutes per day over 30 days)\n\n(These compliance rates will be measured by data which is recorded by the VR headset itself)","From days 1-30 post surgery",{"measure":39,"description":40,"timeFrame":12},"Percentage of participants who withdraw during the trial","This will be measured as a percentage of the total number of participants recruited.",[42],{"measure":43,"description":44,"timeFrame":19},"VR Headset Technical Complications Experienced","The number of VR headset technical complications experienced by participants will be recorded from feedback gathered at study visits",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":48,"timePerspective":48,"maskingInfo":50},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":51,"maskingDescription":52,"whoMasked":53},"DOUBLE","Due to the nature of the intervention, blinding of participants and all research study team members is not possible; however, arm allocation will remain concealed from the participant until baseline data has been collected, and all research study team members will be blinded, except those supporting VR headset training and data collection.",[54,55],"INVESTIGATOR","OUTCOMES_ASSESSOR","Psychological factors, (anxiety in particular) link into the biological human stress response systems and can thus have an important bearing on perioperative outcomes. Current pharmacological and non- pharmacological interventions to manage anxiety are not as effective as desired due to a multitude of reasons (side effects, staffing requirements such as psychologists, expense or lack efficacy).\n\nAddressing psychological factors like perioperative anxiety with a relatively easy to use, non-invasive technique such as Virtual Reality (VR) is likely to improve PROM (Patient Reported Outcome Measures). Recently, Virtual Reality (VR) has emerged as a non-pharmacological method to manage preoperative anxiety. VR is theorised to decrease perioperative pain and anxiety by diverting attention away from nociception stimulus, extinction of negative expectancy and fear towards pain and modulating pain related neuroendocrine stress responses. VR thus is able to improve PROM (Patient Reported Outcome Measures) and also improve post-operative pain \u002Fopioid use, length of stay in hospital and joint arthroplasty complication rates.\n\nThe researchers aim to perform a pilot feasibility study in preparation for the multi-centre randomised control trial that will follow. The primary objective of the pilot feasibility trial will be to test the acceptability, level of adherence to the trial protocol by patients, the ease with which the intervention can be implemented and estimates of the effect size\u002Fvariability that should be used in the statistical design of the main study.",[58,65],{"label":59,"type":60,"description":48,"interventionNames":61},"VR Headset + Questionnaires","ACTIVE_COMPARATOR",[62,63,64],"Device: Virtual Reality Headset","Diagnostic Test: Blood Samples","Behavioral: Questionnaires",{"label":66,"type":60,"description":48,"interventionNames":67},"Usual Standard of Care + Questionnaires",[63,64],[69,74,79],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":48},"DEVICE","Virtual Reality Headset","Use of VR Headset for 20 minutes per day, from between 10 and 7 days pre surgery to 30 days post surgery",[59],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":48},"DIAGNOSTIC_TEST","Blood Samples","Blood samples will be collected from 5 participants randomly selected from each arm. Samples will be collected at baseline, day of surgery, 24 hours post surgery, 30 days post surgery and 90 days post surgery",[66,59],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":48},"BEHAVIORAL","Questionnaires","Baseline and then FU data at 7, 14, 21, 30 and 90 days post-operative will be collected from participants via questionnaires",[66,59],[85,90],{"name":86,"role":87,"phone":88,"phoneExt":48,"email":89},"Devjit Srivastava","CONTACT","+44 1463 705350","dev.srivastava@nhs.scot",{"name":91,"role":87,"phone":92,"phoneExt":48,"email":93},"Frances Hines","+44 1463 255912","frances.hines@nhs.scot",[95],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"National Treatment Centre - Highland","RECRUITING","Inverness","Highlands","IV2 5NA","United Kingdom","UK",{"type":104,"coordinates":105},"Point",[106,107],-4.22398,57.47908,{"lat":107,"lon":106},[110],{"name":86,"role":87,"phone":88,"phoneExt":48,"email":89},{"type":112,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[114],{"name":115,"class":116},"Healthy Mind","INDUSTRY","100659961","virtual-reality-therapy-to-improve-arthroplasty-outcomes-100659961",false,"NCT07872670","Virtual Reality Therapy to Improve Arthroplasty Outcomes","Pilot Randomised Controlled Trial of Virtual Reality Immersive Therapy (VRIT) in Addition to Usual Care Compared to Usual Care in Patients Undergoing Joint Arthroplasty - VROOM Trial","VROOM","Inclusion Criteria:\n\n* NHS Highland patients\n* Able to provide written informed consent (remotely)\n* ASA Grade 1 and 2\n* Listed for elective surgery at NHSH NTC\n* Adults\\>18 years undergoing joint arthroplasty surgery (hip and knee) will be included\n* Fluent in English\n* Able to receive and write emails\n* Willing to comply with study protocols\u002Ftraining\n* Access to Wi-Fi to undertake VRIT and complete questionnaires online\n\nExclusion Criteria:\n\n* Not able to provide written informed consent\n* Considered unsuitable by Clinician (with reason)\n* Vision \u002Fhearing difficulties which preclude interaction with immersive environment\n* Unable or unwilling to comply with study procedures and activities\n* Participation in another interventional trial which undermines the scientific basis of the study\n* Have a history of alcohol or substance abuse or Parkinson's disease or Multiple Sclerosis or Labyrinthitis (Ménière's disease), history of seizures, motion sickness or dementia\n* Non NHS Highland patients\n* Photosensitive epilepsy\n* Patients with surgery scheduled for a Friday","ALL","18 Years",{"count":128,"type":129},40,"ESTIMATED","INTERVENTIONAL",[132],"NA","Virtual reality (VR) has recently emerged as a non-medication-based method to manage anxiety. The patient wears a VR headset and is offered an immersive environment with hypnotic components with sound and imagery in a 3D environment. VR creates an immersive 3D environment and diverts attention away from worrying thoughts (anxiety) and pain and has been found useful to manage minor procedural pain and related anxiety.\n\nThis is a pilot feasibility trial to evaluate the effectiveness of VR in improving patient related outcomes (PROM) after joint replacement surgery.",[135,136,137,138],"Surgical","Anxiety","Pain Management","Joint (Knee or Hip Replacement)",[140,141,136,142,143,144],"Psychology","Surgery","Perioperative","Virtual reality","Joint arthroplasty","2026-10-08",{"date":147,"type":148},"2026-10-13","ACTUAL",{"date":150,"type":148},"2026-03-05",{"date":152,"type":129},"2026-12-01",{"name":5,"class":6},1]