Binaural Beats for Postoperative Pain and Anxiety Reduction
Purpose
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)
- Total Knee Arthroplasty
- Total Knee Replacement
- Total Hip Replacement
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Miami
