[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637991":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":65,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Music Group","ACTIVE_COMPARATOR","Open ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued.",[13],"Behavioral: Music",{"label":15,"type":16,"description":11,"interventionNames":17},"Control Group (No music)","SHAM_COMPARATOR",[18],"Behavioral: Control Group (no music)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Music","Music will be selected from a standardized playlist and initiated by a member of the research team.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Control Group (no music)","Headphones will be worn without audio; no music will be played.",[15],[31],{"name":32,"affiliation":33,"role":34},"Shyamal Asher, MD","Brown University Health","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Shyamal Asher, M.D.","CONTACT","401-444-5172","SAsher@brownhealth.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Rhode Island Hospital","RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.41283,41.82399,{"lat":54,"lon":53},[57,61],{"name":58,"role":38,"phone":59,"phoneExt":25,"email":60},"Stephanie Farias","1 (401) 444-4943","Stephanie.Farias@brownhealth.org",{"name":62,"role":38,"phone":63,"phoneExt":25,"email":64},"Mark Kendall, M.D.","401-444-4722","mark.kendall@brownhealth.org",{"type":34,"investigatorFullName":32,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator","100637991","intraoperative-music-therapy-in-tavr-patients-100637991",false,"NCT07591922","Intraoperative Music Therapy in TAVR Patients","Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience","Inclusion Criteria:\n\n* Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital\n* Able to answer questions about anxiety\n\nExclusion Criteria:\n\n* Transfemoral TAVR procedures requiring general anesthesia\n* Emergent TAVR procedures\n* Significant hearing impairment that would preclude ability to hear music via headphones\n* Documented severe claustrophobia or inability to tolerate headphones\n* Inability to complete questionnaires\n* Inability or unwillingness to provide informed consent","ALL","18 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","The purpose of this study is to evaluate the effect of intraoperative music on patient anxiety and comfort during transcatheter aortic valve replacement (TAVR) procedures.",[84],"Anxiety",[84,22,86,87],"Heart valve surgery","Intraoperative","2026-05-14",{"date":90,"type":91},"2026-05-18","ACTUAL",{"date":93,"type":78},"2026-05-13",{"date":95,"type":78},"2027-05",{"name":5,"class":6},1]