Anxiety, Binaural Beats, Music Exposure, THA, TKA, Total Hip Arthroplasty (THA), Total Hip Replacement, Total Knee Arthroplasty, Total Knee Replacement
Conditions
Keywords
THA, TKA, Total hip arthroplasty, Total knee arthroplasty, Anxiety, Pain, Binaural Beats, Music Exposure
Brief 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).
Interventions
OTHERBinaural Beats Audio Intervention
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.
OTHERMusic of Choice
Usual postoperative care in addition to patient-selected music using standardized headphones
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score Numeric Pain Rating Scale (NPRS) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME) | From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation) | 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) |
| Postoperative Vital Signs Heart Rate | Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation). | Heart rate (beats per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
| Patient Satisfaction Score | Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation | 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) |
| Postoperative Vital Signs Blood Pressure | Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation). | 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. |
| Postoperative Vital Signs Respiratory Rate | Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation). | Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Countries
United States
Contacts
CONTACTAndrew R Moya, MD
PRINCIPAL_INVESTIGATORVictor H Hernandez, MD, MSc
University of Miami
Outcome results
None listed