Intraoperative Music Therapy in TAVR Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Music; Behavioral: Control Group (no music)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shyamal Asher, M.D.; Phone Number: 401-444-5172; Email: SAsher@brownhealth.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • The Rhode Island Hospital
      • Contact: Mark Kendall, M.D.; Phone Number: 401-444-4722; Email: mark.kendall@brownhealth.org
      • Contact: Stephanie Farias; Phone Number: 1 (401) 444-4943; Email: Stephanie.Farias@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Music; Music will be selected from a standardized playlist and initiated by a member of the research team.
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.	Behavioral: Control Group (no music); Headphones will be worn without audio; no music will be played.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	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."	24 hours after surgery

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Shyamal Asher, MD, Brown University Health

Publications and helpful links

General Publications

• Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
• Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
• Cruise CJ, Chung F, Yogendran S, Little D. Music increases satisfaction in elderly outpatients undergoing cataract surgery. Can J Anaesth. 1997 Jan;44(1):43-8. doi: 10.1007/BF03014323.
• Ebrahimi R, Tan W. Role of Music for Conscious Sedation During Invasive Cardiac Catheterization. Am J Cardiol. 2018 Sep 15;122(6):1095-1097. doi: 10.1016/j.amjcard.2018.05.039. Epub 2018 Jun 20.

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Music; Intraoperative; Heart valve surgery
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Control Groups; Music Therapy
• Other Study ID Numbers: 2401855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No