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Recruiting NCT07437469

Binaural Beats for Postoperative Pain and Anxiety Reduction

No phase Interventional TKA THA Anxiety Binaural Beats

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Binaural Beats Audio Intervention, Music of Choice.
Who it may be relevant to
Registry conditions: TKA, THA, Anxiety, Binaural Beats. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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).

Interventions

  • Other Binaural Beats Audio Intervention
    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.
  • Other Music of Choice
    Usual postoperative care in addition to patient-selected music using standardized headphones

Primary outcome measures

  • Change in Pain Score Numeric Pain Rating Scale (NPRS) [Time frame: Baseline (pre-operative) to 4 hours post-operation.]
  • Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S) [Time frame: Baseline (pre-operative) to 4 hours post-operation.]
Secondary outcome measures (5)
  • 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)]
  • Postoperative Vital Signs Heart Rate [Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).]
  • Patient Satisfaction Score [Time frame: Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation]
  • Postoperative Vital Signs Blood Pressure [Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).]
  • Postoperative Vital Signs Respiratory Rate [Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Univeristy of Miami Health System — Miami

Identifiers

NCT: NCT07437469 · 20251389

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗