[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563450":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":60,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Standard treatment with Virtual Reality headset and Active-Noise-Cancelling headphones",[13],"Device: Virtual Reality",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Standard treatment without VR headset and ANC-headphones",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Virtual Reality","Participants in the intervention group will undergo ESWL according to standard treatment but with the addition of Virtual Reality and ANC-headphones as a supplement.",[9],[26],{"name":27,"affiliation":28,"role":29},"Karsten L Lassen, PhD student","Urologisk Afdeling, Region Sjælland","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","4526131350","karlas@regionsjaelland.dk",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Nanna W Christiansen, Engineer","4540306799","nanchr@regionsjaelland.dk",[40],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Urologisk Afdeling","RECRUITING","Roskilde","4000","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],12.08035,55.64152,{"lat":51,"lon":50},[54,57,58],{"name":55,"role":32,"phone":56,"phoneExt":18,"email":34},"Karsten Lomholt Lassen PhD. student, CRNA","0045 261313509",{"name":18,"role":32,"phone":18,"phoneExt":18,"email":34},{"name":59,"role":29,"phone":18,"phoneExt":18,"email":18},"Karsten Lassen, PhD. student",{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100563450","virtual-reality-to-reduce-pain-and-anxiety-during-extracorporeal-shock-wave-lithotripsy-100563450",false,"NCT06616324","Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy","Virtual Reality: An Innovative Approach to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Scheduled for ESWL at Region Zealand\n* Age of 18 or above\n* Ability to understand the trial protocol, risks, and benefits and provide signed informed consent\n\nExclusion Criteria:\n\n* Inability to read and understand Danish.\n* Uncooperativeness (as judged by investigators)\n* Claustrophobia or fear of small spaces\n* Disorders that prevent the person from wearing a VR device\n* Highly visually or auditive impaired","ALL","18 Years",{"count":72,"type":73},72,"ESTIMATED","INTERVENTIONAL",[76],"NA","The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements.\n\nThe primary outcome is pain at energy level 900 during ESWL for the intervention and the control group.\n\nThe secondary outcomes are as follows:\n\n* Type and dose of analgesia\n* Conductance scores\u002Fvalues\n* Anxiety levels\n* Patient satisfaction\n* Procedure duration\n* Adverse events\n\nParticipants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not",[79,80,22,81],"Anxiety","Pain","Lithotripsy",[22,80,79,83,84,85,81,86],"VR","ESWL","Extracorporeal Shock Wave Lithotripsy","Non-pharmacological","2025-09-22",{"date":89,"type":90},"2025-09-23","ACTUAL",{"date":92,"type":90},"2024-10-24",{"date":94,"type":73},"2025-10-01",{"name":5,"class":6},1]