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NCT Number: NCT07591922

Intraoperative Music Therapy in TAVR Patients

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Participant satisfaction

    Time frame: 24 hours after surgery

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Shyamal Asher, M.D.

CONTACT

[email protected]

401-444-5172

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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