Recruiting

Intraoperative Music

Sponsor:

Rhode Island Hospital

Code:

NCT07591922

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Music

Control Group (no music)

Study Details

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

Study ID

NCT07591922

Start date

May 26, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Music

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

Control Group (no music)

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Shyamal Asher, M.D.

401-444-5172SAsher@brownhealth.org

Locations

The Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Stephanie Farias

1 (401) 444-4943Stephanie.Farias@brownhealth.org

Mark Kendall, M.D.

401-444-4722mark.kendall@brownhealth.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jul 20, 2026

Last verified

May, 2026

Keywords

  • Anxiety
  • Music
  • Heart valve surgery
  • Intraoperative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-07-20.