Binaural Beats for Postoperative Pain and Anxiety Reduction

University of Miami

Status: Enrolling

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

Treatments: Other: Music of Choice; Other: Binaural Beats Audio Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07437469

20251389

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Binaural Beats (BB)

Experimental group

Description:

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.

Treatment:

Other: Binaural Beats Audio Intervention

Music of Choice (MOC)

Active Comparator group

Description:

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.

Treatment:

Other: Music of Choice