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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binaural Beats Audio Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (pre-operative) to 4 hours post-operation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew R Moya, MD | Contact | 1786-856-6463 | arm577@miami.edu, doc.a.moya1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Victor H Hernandez, MD, MSc | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Miami Health System | Recruiting | Miami | Florida | 33132 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Music of Choice | Other | Usual postoperative care in addition to patient-selected music using standardized headphones |
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| 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. | 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 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. | 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. | Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation). |