Intraoperative Music Therapy in TAVR Patients

NCT07591922 | Recruiting

• 1 other identifier: 2401855
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

Anxiety; Music; Heart valve surgery; Intraoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant satisfaction

  24 hours after surgery

Study Arms (2)

Music Group

ACTIVE COMPARATOR

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

Control Group (No music)

SHAM COMPARATOR

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)

Interventions

Music BEHAVIORAL

Music will be selected from a standardized playlist and initiated by a member of the research team.

Music Group

Control Group (no music) BEHAVIORAL

Headphones will be worn without audio; no music will be played.

Control Group (No music)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital
• Able to answer questions about anxiety

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

The Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 22588767 BACKGROUND

• 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.

  PMID: 8988823 BACKGROUND

• 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.

  PMID: 36371942 BACKGROUND

• 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.

  PMID: 30072130 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy; Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shyamal Asher, MD

  Brown University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shyamal Asher, M.D.

CONTACT

401-444-5172; SAsher@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The surgeon will also be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 18, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)