Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID07437469

Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled Trial

Led by University of Miami · Updated on 2026-04-30

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a 30-minute binaural beats audio session on pain and anxiety in adults undergoing outpatient total knee or hip replacement surgery. The trial compares this intervention with listening to participant-selected music during the early recovery period after surgery. The study is designed as a randomized controlled trial led by the University of Miami to understand whether binaural beats can influence postoperative outcomes. Participants are randomly assigned to one of two groups. One group listens to a 30-minute binaural beats audio session through standardized over-ear headphones shortly after arriving in the post-anesthesia care unit (PACU). The audio targets a 10 Hz alpha frequency using specific sound tones and is played at a comfortable volume. The other group receives usual postoperative care and may listen to their preferred music through the same type of headphones for 30 minutes. Music listening is optional and can be stopped anytime. During the study, participants’ pain and anxiety levels are measured before surgery and again four hours after surgery using validated scales. Researchers also monitor opioid use, vital signs such as heart rate, blood pressure, and respiratory rate every 30 minutes while in the PACU. Patient satisfaction is assessed once during the PACU stay. The study aims to capture these outcomes within the first four hours after surgery to evaluate early postoperative recovery effects. Total participation time is limited to the immediate postoperative period in the PACU.

CONDITIONS

Brief Title

Binaural Beats for Postoperative Pain and Anxiety Reduction

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3
  • Receiving spinal anesthesia
  • Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)
  • Undergoing primary total hip or total knee arthroplasty
Not Eligible

You will not qualify if you...

  • Moderate to severe hearing impairment or use of hearing aids
  • History of significant tinnitus
  • Active delirium
  • Chronic high-dose opioid therapy (more than 60 MME/day baseline)
  • Major psychiatric pathology
  • General anesthesia use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 hours post-operation

Participants receive either a 30-minute binaural beats audio session or listen to music of their choice through standardized headphones in the post-anesthesia care unit (PACU) shortly after surgery.

1 visit (in-person) during PACU stay

Trial Site Locations

Total: 1 location

1

Univeristy of Miami Health System

Miami, Florida, United States, 33132

Actively Recruiting

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Research Team

A

Andrew R Moya, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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