Binaural Beats for Postoperative Pain and Anxiety Reduction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Miami

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Binaural Beats Audio Intervention

    Other 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.

  • Music of Choice

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Binaural Beats (BB)Experimental treatment 1 intervention
Group B: Music of Choice (MOC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain Score Numeric Pain Rating Scale (NPRS)

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.

Time frame
Baseline (pre-operative) to 4 hours post-operation.
2

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

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.

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

Secondary outcomes

1

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

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)

Time frame
From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
2

Postoperative Vital Signs Heart Rate

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

Time frame
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
3

Patient Satisfaction Score

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)

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

Postoperative Vital Signs Blood Pressure

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.

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

Other outcomes

Sponsors and contacts

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