双耳节拍用于减轻术后疼痛和焦虑
双耳节拍与自选音乐对门诊全膝关节和全髋关节置换术后早期疼痛的缓解效果：一项随机对照试验
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).
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Andrew R Moya, MD
- 电话号码：1786-856-6463
- 邮箱：arm577@miami.edu, doc.a.moya1@gmail.com
学习地点
-
-
Florida
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Miami、Florida、美国、33132
- 招聘中
- Univeristy of Miami Health System
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首席研究员：
- Victor H Hernandez, MD
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接触：
- Andrew R Moya, MD
- 电话号码：786-856-6463
- 邮箱：arm577@miami.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
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. |
|
有源比较器：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. |
Usual postoperative care in addition to patient-selected music using standardized headphones |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pain Score Numeric Pain Rating Scale (NPRS)
大体时间：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. |
Baseline (pre-operative) to 4 hours post-operation.
|
|
Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)
大体时间：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. |
Baseline (pre-operative) to 4 hours post-operation.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)
大体时间：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) |
From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
|
|
Postoperative Vital Signs Heart Rate
大体时间：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. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
|
Patient Satisfaction Score
大体时间：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) |
Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
|
|
Postoperative Vital Signs Blood Pressure
大体时间：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. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
|
Postoperative Vital Signs Respiratory Rate
大体时间：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. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
合作者和调查者
调查人员
- 首席研究员：Victor H Hernandez, MD, MSc、University of Miami
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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