The BARBER Trial: Music and Binaural Beats During Prostate Biopsy
Classical Music and Binaural Beats During Prostate Biopsy: The BARBER Randomized Controlled Trial
The goal of this clinical trial was to learn whether listening to classical music or binaural beats could reduce anxiety and pain in adult men undergoing prostate biopsy.
The main questions it aimed to answer were:
- Does listening to classical music reduce anxiety and pain during prostate biopsy compared with no music?
- Does listening to classical music with binaural beats reduce anxiety and pain during prostate biopsy compared with classical music alone or no music?
Researchers compared three groups of participants: one group listened to classical music, one group listened to the same music with binaural beats, and one group did not listen to music.
Participants were asked to complete anxiety questionnaires before and after the biopsy. They also rated their pain after the procedure, and blood pressure and heart rate were recorded before and after the biopsy.
研究概览
地位
详细说明
Prostate biopsy is a common urological procedure that may be associated with anxiety, pain, and discomfort. Music listening and binaural beats have been proposed as low-risk, non-pharmacological strategies to improve patient comfort during medical procedures.
This study was designed to evaluate whether a standardized auditory intervention could reduce anxiety and pain in men undergoing prostate biopsy under local anesthesia. Eligible participants were randomly assigned to one of three groups: classical music, the same classical music track embedded with binaural beats, or no music. Anxiety was assessed before and after the procedure using the State-Trait Anxiety Inventory Form Y, while pain was assessed using a visual analog scale. Physiological parameters were also recorded before and after the procedure.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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TS
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Trieste、TS、意大利、34100
- Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male patients aged 18 years or older
- Scheduled to undergo prostate biopsy
- Italian speaking
- At least formal schooling, defined as 1 to 8 years of education
- Able to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Severe hearing loss requiring the use of a hearing aid
- History of epilepsy
- Psychiatric disorders
- History of chronic pelvic pain syndrome
- Chronic use of antidepressant and/or analgesic drugs
- Use of analgesic drugs within 24 hours before the procedure
- Previous prostate biopsy
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Binaural Beats Group
Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure.
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Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure.
The binaural beat was generated by presenting a 384-Hz tone to the right ear and a 378-Hz tone to the left ear.
The audio track was delivered through wireless stereo headphones.
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有源比较器：Classical Music Group
Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure.
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Participants listened to Samuel Barber's *Adagio for Strings* during the prostate biopsy procedure.
The same musical track used in the binaural beats group was delivered without embedded binaural beats through wireless stereo headphones.
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有源比较器：No Music Group
Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
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Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
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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 |
|---|---|---|
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Change in State Anxiety Score
大体时间：Baseline and 15 minutes after prostate biopsy
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Change in state anxiety score from baseline to after prostate biopsy, assessed using the State-Trait Anxiety Inventory Form Y-1.
The change was compared between the study groups.
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Baseline and 15 minutes after prostate biopsy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Score After Prostate Biopsy
大体时间：15 minutes after prostate biopsy
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Pain intensity after prostate biopsy, assessed using a visual analog scale ranging from 0 to 10, where higher scores indicate greater pain.
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15 minutes after prostate biopsy
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
与本研究相关的术语
其他研究编号
- BARBER-136-2023
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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