[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610939":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":30,"collaborators":18,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":18,"enrollmentInfo":43,"targetDuration":18,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":18},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Music","EXPERIMENTAL","Group submitted to prostate biopsy with music",[13],"Other: Music intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"No music","NO_INTERVENTION","Group submitted to prostate biopsy without music",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Music intervention","music during the biopsy",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Luca Boeri, MD","CONTACT","+393663142529","luca.boeri@policlinico.mi.it",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Luca Boeri","Dr","100610939","the-influence-of-music-on-perceived-pain-and-levels-of-anxiety-while-undergoing-transperineal-prostate-biopsy-the-vivaldi-trial-100610939",false,"NCT07234097","The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial","VIVALDI","Inclusion Criteria:\n\n* Suspected prostate cancer eligible for transperineal prostate biopsy\n* Patients who have signed informed consent\n* Age \\> 50 years\n* Male\n\nExclusion Criteria:\n\n* patients who have had prostate biopsies in the past","MALE","50 Years",{"count":44,"type":45},78,"ESTIMATED","INTERVENTIONAL",[48],"NA","Prostate biopsy is the key examination for the histological diagnosis of prostate cancer. This procedure can be performed via the transrectal (TR) or transperineal (TP) approach. Current Guidelines recommend the transperineal route because it is associated with fewer infectious complications compared to the transrectal approach. However, when the same type of anesthesia is used, the transperineal approach is more painful.\n\nSeveral strategies have been developed to improve pain management during TR biopsy. Some studies have shown that allowing patients to listen to music during the procedure can reduce perceived pain and stress. However, this effect has never been investigated in TP biopsies, which are now the gold standard and generally more painful than TR biopsies.\n\nPrimary Objective:\n\nTo evaluate the reduction in pain levels in patients undergoing transperineal prostate biopsy with the aid of music compared to patients undergoing the same procedure without music.\n\nSecondary Objectives:\n\nTo evaluate the reduction in stress levels related to the procedure in patients undergoing transperineal prostate biopsy with music compared to those without music.\n\nTo evaluate the reduction in the use of painkillers and sedatives during the procedure in patients undergoing transperineal biopsy with music compared to those without.\n\nTo assess pain management and procedure tolerability in both groups.",[51,52],"Prostate Cancer","Pain Management",[54,55],"pain management","prostate biopsy","NOT_YET_RECRUITING","2025-11-14",{"date":59,"type":60},"2025-11-18","ACTUAL",{"date":62,"type":45},"2025-12-01",{"date":64,"type":45},"2026-04-30",{"name":5,"class":6}]