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NCT07591922NARecruiting

Intraoperative Music Therapy in TAVR Patients

Rhode Island Hospital

Start Date

5/26/2026

Completion Date

5/1/2027

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Music

BEHAVIORAL

Control Group (no music)

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Conditions

Anxiety

Locations

The Rhode Island Hospital

Providence, Rhode Island 02903

United States