Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rhode Island Hospital
- Enrollment
- 100
- Locations
- 1
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Investigator)
Masking Description
The surgeon will also be blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Control Group (no music) (Behavioral)
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.
Intervention: Music (Behavioral)
Investigators
Shyamal Asher, MD
Principal Investigator
Rhode Island Hospital