NCT07591922 · Rhode Island Hospital
Intraoperative Music Therapy in TAVR Patients
What this study is about
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.
View original scientific description
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations