Intraoperative Music Therapy in TAVR Patients

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT07591922
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Music — BEHAVIORAL
    Music will be selected from a standardized playlist and initiated by a member of the research team.
  • Control Group (no music) — BEHAVIORAL
    Headphones will be worn without audio; no music will be played.

Study Details

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.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Music Group
    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.
  • Sham Comparator: Control Group (No music)
    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.

Primary Outcome Measure

Anxiety [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Rhode Island HospitalProvidenceRhode Island02903
Stephanie Farias
[email protected]
1 (401) 444-4943
Mark Kendall, M.D.
[email protected]
401-444-4722

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By research site
The Rhode Island Hospital· Providence, RI

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