Recruiting

Binaural Beats

Sponsor:

University of Miami

Code:

NCT07437469

Conditions

TKA

THA

Anxiety

Binaural Beats

Music Exposure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Binaural Beats Audio Intervention

Music of Choice

Study Details

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

Study ID

NCT07437469

Start date

Mar 9, 2026

Status verified date

Sep, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Music of Choice

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Andrew R Moya, MD

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

Locations

Univeristy of Miami Health System

Recruiting

Miami, Florida, United States, 33132

Contacts

Andrew R Moya, MD

786-856-6463arm577@miami.edu

Principal Investigator:

Victor H Hernandez, MD

More Information

Sponsor

University of Miami

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Miami on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.