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NCT Number: NCT07437469

Binaural Beats for Postoperative Pain and Anxiety Reduction

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).

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Key information

Conditions

TKA Anxiety Anxiety Disorders Binaural Beats Mental Disorders Music Exposure Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms THA Total Hip Arthroplasty (THA) Total Hip Replacement Total Knee Arthroplasty Total Knee Replacement

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Miami Health System

Miami, Florida, 33132, United States

Location status: Recruiting

Location contact

Andrew R Moya, MD

CONTACT

[email protected]

786-856-6463

Victor H Hernandez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Binaural Beats Audio Intervention

Other

30-minute binaural beats audio session targeting 400 and 410 hertz (Hz) alpha 400 hertz (Hz) in one ear 410 hertz (Hz) in other ear frequency delivered through standardized headphones in the PACU.

Music of Choice

Other

Usual postoperative care in addition to patient-selected music using standardized headphones

Primary outcomes

  1. Change in Pain Score Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline (pre-operative) to 4 hours post-operation.

    Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where 0 = no pain and 10 = worst imaginable pain. Change will be calculated as the difference between the pre-operative NPRS score and the NPRS score obtained 4 hours after surgery. Higher scores indicate greater pain intensity.

  2. Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)

    Time frame: Baseline (pre-operative) to 4 hours post-operation.

    Anxiety will be measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, producing a total score range of 20-80, with higher scores indicating greater state anxiety. Change will be calculated as the difference between the pre-operative STAI-S score and the STAI-S score obtained 4 hours after surgery.

Secondary outcomes

  1. Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)

    Time frame: From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)

    Total opioid use administered during the post-anesthesia care unit (PACU) stay will be recorded, including all intravenous and oral opioid medications. All doses will be converted to morphine milligram equivalents (MME) using standard Centers for Disease Control and Prevention (CDC) conversion factors. Unit of Measure: Morphine milligram equivalents (MME)

  2. Postoperative Vital Signs Heart Rate

    Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).

    Heart rate (beats per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.

  3. Patient Satisfaction Score

    Time frame: Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation

    Patient satisfaction with the postoperative experience will be measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. Unit of Measure: Likert score (1-5)

  4. Postoperative Vital Signs Blood Pressure

    Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).

    Systolic and diastolic blood pressure (millimeters of mercury) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.

  5. Postoperative Vital Signs Respiratory Rate

    Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).

    Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew R Moya, MD

CONTACT

[email protected], [email protected]

1786-856-6463

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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