Binaural Beats for Postoperative Pain and Anxiety Reduction
Recruiting · NCT07437469 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Binaural Beats Audio InterventionMusic of Choice
What this trial is about
To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).
Who can take part
Age range
18 Years to 99 Years
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
- American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3
- Spinal anesthesia
- Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)
- Primary total hip or total knee arthroplasty
Exclusion criteria
- Moderate-severe hearing impairment or use of hearing aids
- History of significant tinnitus, active delirium, chronic high-dose opioid therapy (\>60 MME/day baseline)
- Major psychiatric pathology
- General anesthesia
Where it is running
1 location listed across 1 US state.
- Univeristy of Miami Health System - Miami, Florida, United States