[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637991":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":29,"studyPopulation":18,"armGroups":30,"interventions":42,"overallOfficials":52,"centralContacts":57,"locations":63,"responsibleParty":87,"collaborators":18,"id":89,"slug":18,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":18,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":18,"enrollmentInfo":97,"targetDuration":18,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Anxiety","Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-6), a validated 6-item questionnaire. Scores will be subsequently transformed to the full STAI-S scale (range 20-80) for reporting. Higher scores indicate greater anxiety.","Preoperative (baseline, prior to intervention), intraoperative (after valve deployment), postoperatively upon arrival to the post-anesthesia care unit (PACU) when the patient is alert and able to respond, and 24 hours after surgery.",[14],{"measure":15,"description":16,"timeFrame":17},"Participant satisfaction","A questionnaire comprising multiple items to assess participants' overall intraoperative experience and satisfaction. Each item is scored on a numeric rating scale from 0 to 10, where 0 indicates \"extremely dissatisfied\" and 10 indicates \"extremely satisfied.\"","24 hours after surgery",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":24,"maskingDescription":25,"whoMasked":26},"DOUBLE","The surgeon will also be blinded.",[27,28],"CARE_PROVIDER","INVESTIGATOR","This study is exploring whether listening to music during a minimally invasive heart valve procedure called transcatheter aortic valve replacement (TAVR) can help reduce patient anxiety. TAVR is often done with light sedation, so patients may be awake and aware during parts of the procedure, which can sometimes feel stressful. In this study, patients will be randomly assigned to either listen to relaxing music through headphones during the procedure or to wear headphones without music.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"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.",[36],"Behavioral: Music",{"label":38,"type":39,"description":34,"interventionNames":40},"Control Group (No music)","SHAM_COMPARATOR",[41],"Behavioral: Control Group (no music)",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"BEHAVIORAL","Music","Music will be selected from a standardized playlist and initiated by a member of the research team.",[32],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":18},"Control Group (no music)","Headphones will be worn without audio; no music will be played.",[38],[53],{"name":54,"affiliation":55,"role":56},"Shyamal Asher, MD","Brown University Health","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":18,"email":62},"Shyamal Asher, M.D.","CONTACT","401-444-5172","SAsher@brownhealth.org",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"The Rhode Island Hospital","RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-71.41283,41.82399,{"lat":76,"lon":75},[79,83],{"name":80,"role":60,"phone":81,"phoneExt":18,"email":82},"Stephanie Farias","1 (401) 444-4943","Stephanie.Farias@brownhealth.org",{"name":84,"role":60,"phone":85,"phoneExt":18,"email":86},"Mark Kendall, M.D.","401-444-4722","mark.kendall@brownhealth.org",{"type":56,"investigatorFullName":54,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Principal Investigator","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":98,"type":99},100,"ESTIMATED","INTERVENTIONAL",[102],"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.",[10],[10,45,106,107],"Heart valve surgery","Intraoperative","2026-05-14",{"date":110,"type":111},"2026-05-18","ACTUAL",{"date":113,"type":99},"2026-05-13",{"date":115,"type":99},"2027-05",{"name":5,"class":6},1]