Classical Music and Binaural Beats During Prostate Biopsy: The BARBER Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in State Anxiety Score
时间窗: Baseline and 15 minutes after prostate biopsy
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.
次要结局
- Pain Score After Prostate Biopsy(15 minutes after prostate biopsy)
研究者
Francesca Vedovo
MD, FEBU
University of Trieste