Intraoperative Music Therapy in TAVR Patients
Recruiting · NCT07591922 · Interventional (participants receive a specific treatment) · Lead sponsor: Rhode Island Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Control Group (no music)Music
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- The Rhode Island Hospital - Providence, Rhode Island, United States