Music Therapy for Anxiety During TAVR Procedures

This study is looking at whether listening to music during a heart valve replacement procedure called TAVR (transcatheter aortic valve replacement) can help reduce anxiety. TAVR is a minimally invasive procedure where a new heart valve is put in place, often with light sedation, meaning you might be awake. Researchers want to see if music can make you feel more comfortable. You could join if you are 18 or older, are having an elective TAVR at Rhode Island Hospital with monitored anesthesia care, and can answer questions about your anxiety. You would either listen to music through headphones or wear headphones without music. The study will measure your anxiety before, during, and after the procedure, and again 24 hours later. The study is currently recruiting 100 participants, but its status is unclear.

Study design
This is an interventional study where 100 participants will be randomly assigned to either listen to music or wear headphones without music during their TAVR procedure.
What's involved
You would participate in the TAVR procedure as planned, with the addition of wearing headphones and answering questions about your anxiety at several points.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety will be measured up to 24 hours after your surgery.

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NCT07591922

Intraoperative Music Therapy in TAVR Patients

Recruiting
NAAges 18+InterventionalSupportive care
Rhode Island Hospital
~100 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:MusicControl Group (no music)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anxiety
Measured over 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.
Anxiety
1 sites across 1 states
Rhode Island1
  • Shyamal Asher, MD · PRINCIPAL_INVESTIGATOR · Brown University Health

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Eligibility criteria

Inclusion

Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital
Able to answer questions about anxiety

Exclusion

Transfemoral TAVR procedures requiring general anesthesia
Emergent TAVR procedures
Significant hearing impairment that would preclude ability to hear music via headphones
Documented severe claustrophobia or inability to tolerate headphones
Inability to complete questionnaires
Inability or unwillingness to provide informed consent
  • AnxietyPreoperative (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.

    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.