Binaural Beats for Postoperative Pain and Anxiety Reduction

NCT07437469 | Recruiting

• 1 other identifier: 20251389
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

TKA; THA; Anxiety; Binaural Beats; Music Exposure; Total Hip Arthroplasty (THA); Total Knee Arthroplasty; Total Knee Replacement; Total Hip Replacement

Keywords

THA; TKA; Total hip arthroplasty; Total knee arthroplasty; Anxiety; Pain; Binaural Beats; Music Exposure

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

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

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

• Postoperative Vital Signs Heart Rate

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

• Patient Satisfaction Score

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

• Postoperative Vital Signs Blood Pressure

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

• Postoperative Vital Signs Respiratory Rate

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

Study Arms (2)

Binaural Beats (BB)

EXPERIMENTAL

Participants assigned to this arm will listen to a 30-minute binaural beats audio session at a comfortable volume through standardized over-ear headphones while in the post-anesthesia care unit (PACU). The audio will use a primary target frequency of 10 Hz (alpha range), created using soft sine-wave carriers in the 200-600 Hz range that generate a 10 Hz interaural difference (e.g., 400 Hz left ear / 410 Hz right ear). Volume will be set at a comfortable conversational level (\~55-65 dBA) and may be adjusted by the participant. The session will begin within 15 minutes of PACU arrival. Participants may stop the audio at any time.

Other: Binaural Beats Audio Intervention

Music of Choice (MOC)

ACTIVE COMPARATOR

Participants in this arm will receive usual postoperative care in the post-anesthesia care unit (PACU) and may listen to music of their choice using standardized headphones. They will select their preferred music and listen for 30 minutes at a comfortable volume (\~55-65 dBA), which they may adjust as needed. No binaural beat frequencies will be used. Music listening is optional and may be stopped at any time.

Other: Music of Choice

Interventions

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.

Binaural Beats (BB)

Music of Choice OTHER

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

Music of Choice (MOC)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Univeristy of Miami Health System

Miami, Florida, 33132, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victor H Hernandez, MD, MSc

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew R Moya, MD

CONTACT

1786-856-6463; arm577@miami.edu, doc.a.moya1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Joint Replacement

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)