Binaural Beats for Postoperative Pain and Anxiety Reduction

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07437469
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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.
  • Music of Choice — OTHER
    Usual postoperative care in addition to patient-selected music using standardized headphones

Study Details

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).

Key Dates

Start date
Mar 9, 2026
Status verified
Apr 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Binaural Beats (BB)
    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.
  • Active Comparator: Music of Choice (MOC)
    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.

Primary Outcome Measure

Change in Pain Score Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline (pre-operative) to 4 hours post-operation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Univeristy of Miami Health SystemMiamiFlorida33132
Andrew R Moya, MD
[email protected]
786-856-6463
Victor H Hernandez, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Univeristy of Miami Health System· Miami, FL

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