[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565992":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":35,"studyPopulation":27,"armGroups":36,"interventions":47,"overallOfficials":27,"centralContacts":53,"locations":59,"responsibleParty":95,"collaborators":99,"id":102,"slug":27,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":27,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":27,"enrollmentInfo":111,"targetDuration":27,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Göteborg University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"propofol mg\u002Fkg","dose of propofol given during surgery to the participant","during the surgery (90 minutes max)",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Surgeons satisfaction","surgeons satisfaction, measured with NASA task load index (tlx). Higher score, worse outcome.","Directly after surgery is finished",{"measure":19,"description":20,"timeFrame":12},"Stress\u002Fanxiety","Stress or anxiety felt during surgery by participant, measured with State-Trait Anxiety Inventory (STAI) . Higher score worse outcome.",{"measure":22,"description":23,"timeFrame":17},"Nurse anesthetists experience, (questionnaire).","Nurse anesthetists experience will be measured with a questionnaire egarding how well the monitoring of the patient could be carried out and the degree to which the patient was perceived as calm. The higher score, the better.",{"measure":25,"description":26,"timeFrame":17},"Level of pain","Patients level of pain after surgery, measured with Numeric rating scale (NRS). The higher scores mean worse outcome.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","RCT","TREATMENT",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE","This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery\u002Ftreatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation\u002FVR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations:\n\nHallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia.\n\nSahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters\u002Fguides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration.\n\nAlingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration.\n\nData collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11.\n\nWe also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. Postoperative data will include STAI-S, NRS, intraoperative sedative medication (type and dosage in mg\u002Fkg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward.\n\nThe patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively. The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery.\n\nThe primary outcome effect of VR glasses on mg\u002Fkg of propofol used intraoperatively or another sedative drug and\u002For the amount of local anesthetic used in mg. The secondary outcome effect of VR glasses on anxiety-induced stress perioperatively, where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory (STAI-S).",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"VR group","EXPERIMENTAL","This group use VR glasses during surgery",[42],"Device: Virtual reality",{"label":44,"type":45,"description":46,"interventionNames":27},"Control group","NO_INTERVENTION","Control group without intervention, conventional treatment",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":27},"DEVICE","Virtual reality","Participant will try virtual reality glasses with tailormade software films to see if it's possible to use them as distraction during awake surgery. We will measure doses of propofol given, level of anxiety, experience of the patient and surgeons satisfaction.",[38],[54],{"name":55,"role":56,"phone":57,"phoneExt":27,"email":58},"Pether Jildenstål, Docent","CONTACT","+46760266658","pether.jildenstal@vgregion.se",[60,79],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Alingsås lasarett","RECRUITING","Alingsås","Västra Götaland County","441 33","Sweden","SE",{"type":69,"coordinates":70},"Point",[71,72],12.53345,57.93033,{"lat":72,"lon":71},[75],{"name":76,"role":56,"phone":77,"phoneExt":27,"email":78},"Joakim Strömberg, associate professor","0046313421000","joakim.stromberg@vgregion.se",{"facility":80,"status":62,"city":81,"state":64,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Sahlgrenska universitetssjukhuset","Gothenburg","414 72",{"type":69,"coordinates":84},[85,86],11.96679,57.70716,{"lat":86,"lon":85},[89,93],{"name":90,"role":56,"phone":91,"phoneExt":27,"email":92},"Kristian Hermander, Nurse anesthetist","+46709374816","kristian.hermander@vgregion.se",{"name":94,"role":56,"phone":27,"phoneExt":27,"email":27},"Kristian Hermander",{"type":96,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Pether Jildenstal","Professor Pether Jildenstal Gothenburg University",[100],{"name":101,"class":6},"Sahlgrenska University Hospital","100565992",false,"NCT06649383","Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication","Virtual Reality for Elderly Patients in Anesthesia and Surgical Care","Inclusion Criteria:\n\n* over 65 years, planed surgery in local anesthesia\u002Fregional anesthesia\n\nExclusion Criteria:\n\n* dementia, unable to cooperate, cognitive impairment",true,"ALL","65 Years",{"count":112,"type":113},90,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.",[119,120,121],"Virtual Reality","Distraction","Elderly (people Aged 65 or More)",[123,124],"virtual reality","distraction","2025-01-10",{"date":127,"type":128},"2025-01-13","ACTUAL",{"date":130,"type":128},"2024-12-16",{"date":132,"type":113},"2029-06-15",{"name":97,"class":6},2]