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Recruiting NCT07591922

Intraoperative Music Therapy in TAVR Patients

No phase Interventional Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music, Control Group (no music).
Who it may be relevant to
Registry conditions: Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • Participant satisfaction [Time frame: 24 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The Rhode Island Hospital — Providence

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. PMID 22588767
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07591922 · 2401855

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗