Anxiety
Conditions
Keywords
Anxiety, Music, Heart valve surgery, Intraoperative
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.
Interventions
BEHAVIORALMusic
Music will be selected from a standardized playlist and initiated by a member of the research team.
BEHAVIORALControl Group (no music)
Headphones will be worn without audio; no music will be played.
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The surgeon will also be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction | 24 hours after surgery | A questionnaire comprising multiple items to assess participants' overall intraoperative experience and satisfaction. Each item is scored on a numeric rating scale from 0 to 10, where 0 indicates "extremely dissatisfied" and 10 indicates "extremely satisfied." |
Countries
United States
Contacts
CONTACTShyamal Asher, M.D.
PRINCIPAL_INVESTIGATORShyamal Asher, MD
Brown University Health
Outcome results
None listed