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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07437469
- Acronym / sponsor ID
- 20251389
- Conditions
- TKA, THA, Anxiety, Binaural Beats, Music Exposure, Total Hip Arthroplasty (THA)
- Keywords
- THA, TKA, Total hip arthroplasty, Total knee arthroplasty, Anxiety, Pain, Binaural Beats, Music Exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binaural Beats (BB) | Experimental | Other: Binaural Beats Audio InterventionParticipants 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. |
| Music of Choice (MOC) | Active comparator | Other: Music of ChoiceParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural Beats Audio Intervention30-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. | Other | Binaural Beats (BB) |
| Music of ChoiceUsual postoperative care in addition to patient-selected music using standardized headphones | Other | Music of Choice (MOC) |
Primary outcome
Change in Pain Score Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (pre-operative) to 4 hours post-operation.
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.
Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)
Time frame: Baseline (pre-operative) to 4 hours post-operation.
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.
5 secondary outcomes
Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)
Time frame: From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
Postoperative Vital Signs Heart Rate
Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
Patient Satisfaction Score
Time frame: Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
Postoperative Vital Signs Blood Pressure
Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
Postoperative Vital Signs Respiratory Rate
Time frame: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for TKA
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor H Hernandez, MD, MSc principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew R Moya, MD (1786-856-6463, arm577@miami.edu, doc.a.moya1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score Numeric Pain Rating Scale (NPRS) (time frame: Baseline (pre-operative) to 4 hours post-operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.