Intraoperative Music Therapy for TAVR Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomizes patients undergoing transfemoral TAVR under monitored anesthesia care to listen to relaxing music via headphones or to wear headphones without music. The goal is to see if music during the procedure lowers anxiety and improves comfort. Outcome measures focus on patient-reported anxiety and ease during the procedure, with data collected while awake in parts of the procedure. This is a single-site interventional study led by Rhode Island Hospital to explore a simple, non-pharmacologic approach to improving the patient experience during TAVR.

Why it matters

Who can join: the full rules

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

Where it's running

• The Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Shyamal Asher, MD — Brown University Health
• Study coordinator: Shyamal Asher, M.D.
• Email: SAsher@brownhealth.org
• Phone: 401-444-5172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.