TKANCT07437469
Binaural Beats for Postoperative Pain and Anxiety Reduction
A study testing Binaural Beats Audio Intervention and Music of Choice in people with TKA and THA, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Binaural Beats Audio Intervention and Music of Choice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 31 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Univeristy of Miami Health System
Miami, Florida, 33132
Andrew R Moya, MD, 786-856-6463, arm577@miami.edu
Victor H Hernandez, MD
About this study
Official title: Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled 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).
- Conditions
- TKA, THA, Anxiety, Binaural Beats, Music Exposure, Total Hip Arthroplasty (THA)
- Being tested
- Binaural Beats Audio Intervention, Music of Choice
- Keywords
- THA, TKA, Total hip arthroplasty, Total knee arthroplasty, Anxiety, Pain, Binaural Beats, Music Exposure
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural Beats Audio InterventionOther
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 ChoiceOther
Usual postoperative care in addition to patient-selected music using standardized headphones
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music of Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre-operative) to 4 hours post-operation.
Secondary outcomes (5)
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)
Measured: From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
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.
Measured: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
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)
Measured: Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
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.
Measured: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
Postoperative Vital Signs Respiratory Rate
Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record.
Measured: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start9 Mar 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TKAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor H Hernandez, MD, MSc, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437469
- Sponsor's protocol ID
- 20251389
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No