RecruitingRecruiting
Binaural Beats for Postoperative Pain and Anxiety Reduction
NCT07437469 · University of Miami
In plain English
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Official title
Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled Trial
About this study
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).
Eligibility criteria
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
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-09
Estimated completion: 2026-08-30
Last updated: 2026-04-30
Interventions
Other: Binaural Beats Audio InterventionOther: Music of Choice
Primary outcomes
- • Change in Pain Score Numeric Pain Rating Scale (NPRS) (Baseline (pre-operative) to 4 hours post-operation.)
- • Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S) (Baseline (pre-operative) to 4 hours post-operation.)
Sponsor
University of Miami · other
Contacts & investigators
ContactAndrew R Moya, MD · contact · arm577@miami.edu, doc.a.moya1@gmail.com · 1786-856-6463
InvestigatorVictor H Hernandez, MD, MSc · principal_investigator, University of Miami
All locations (1)
Univeristy of Miami Health SystemRecruiting
Miami, Florida, United States