Intraoperative Music Therapy in TAVR Patients
ConditionAnxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRhode Island Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital
Able to answer questions about anxiety
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Music
BehavioralMusic will be selected from a standardized playlist and initiated by a member of the research team.
Control Group (no music)
BehavioralHeadphones will be worn without audio; no music will be played.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Music GroupActive comparator 1 intervention
Group B: Control Group (No music)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety
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.
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.Secondary outcomes
1
Participant satisfaction
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."
Time frame
24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov