Binaural beats to reduce pain and anxiety after hip or knee replacement
Binaural Beats vs Music of Choice for Early Postoperative Pain After Ambulatory Total Knee and Total Hip Arthroplasty: A Randomized Controlled Trial
NA · University of Miami · NCT07437469
This will try a 30-minute binaural beats audio session in the PACU to see if it lowers pain and anxiety for adults having same-day total hip or knee replacement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07437469 on ClinicalTrials.gov |
What this trial studies
Adults undergoing ambulatory primary total knee or total hip arthroplasty under spinal anesthesia with a postoperative nerve block will receive a 30-minute binaural beats audio intervention in the post-anesthesia care unit (PACU). Pain and anxiety outcomes will be collected immediately after surgery and again four hours after surgery completion. The intervention is compared with music of the patient's choice as an alternative audio exposure. The approach tests a brief, non-pharmacologic method for short-term postoperative symptom relief.
Who should consider this trial
Good fit: Ideal candidates are adults having primary ambulatory total hip or knee arthroplasty under spinal anesthesia with a postoperative nerve block, ASA class 1–3, without significant hearing loss or chronic high-dose opioid use.
Not a fit: Patients with moderate-to-severe hearing impairment or hearing-aid use, significant tinnitus, active delirium, major psychiatric disorders, chronic high-dose opioid therapy (>60 MME/day), or those receiving general anesthesia are unlikely to benefit.
Why it matters
Potential benefit: If effective, the audio intervention could lower postoperative pain and anxiety and reduce short-term opioid needs after ambulatory hip or knee replacement.
How similar studies have performed: Previous small trials and music-therapy research have shown modest reductions in postoperative anxiety and pain with audio interventions, but evidence specifically for binaural beats is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida
- Univeristy of Miami Health System — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Victor H Hernandez, MD, MSc — University of Miami
- Study coordinator: Andrew R Moya, MD
- Email: arm577@miami.edu, doc.a.moya1@gmail.com
- Phone: 1786-856-6463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TKA, THA, Anxiety, Binaural Beats, Music Exposure, Total Hip Arthroplasty, Total Knee Arthroplasty, Total Knee Replacement