Placebo-Controlled, Randomized, Double-Blind Trial on the Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Effect on pain severity
研究概览
简要总结
This study evaluates the effect of binaural beats on pain perception and subsequent need for analgesic medication use in patients suffering from diseases causing chronic pain. All patients will receive two consecutive interventions: binaural beat signals embedded in relaxing music and placebo (relaxing music without the binaural beat component), in random order.
详细描述
Binaural beats consist of two artificially produced sound waves, differing in wave frequency, presented simultaneously and separately to each ear. The brain, following binaural beat processing, synchronizes to the frequency difference between the two waves. Therefore, using a 5 Hz frequency difference (theta rhythm), which promotes relaxation, we could alleviate pain perception and subsequent analgesic medication use.
Patients suffering from chronic pain will receive two consecutive interventions: binaural beat signals embedded in relaxing music and placebo (relaxing music without the binaural beat component), in random order.
Electroencephalogram (EEG) recordings will be used to confirm brain frequency synchronization, whereas pain severity scales and a diary recording analgesic medication use will be used to identify differences between intervention and placebo arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain
- •Regular analgesic medication use
排除标准
- •Malignant pain
- •Headache as the cause of chronic pain
- •Hearing disability
- •Neuropsychiatric disease
- •Previous experience with binaural beats
研究组 & 干预措施
Binaural Beats
Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design
干预措施: Music with Binaural Beats (Device)
Placebo
Music: Relaxing music without the binaural beat component, in a crossover design
干预措施: Music (Device)
结局指标
主要结局
Effect on pain severity
时间窗: After 30 minutes of listening to binaural beat signals or sham intervention
Comparing pre- and post-intervention perceived pain levels, using a Numeric Rating Scale (NRS) 0-10
Effect on analgesic medication use
时间窗: One week on an "as needed" basis intervention use to alleviate pain, keeping a diary
Comparing analgesic medication active substance quantity used, documented on patient diary recordings
次要结局
- Effect on electroencephalogram (EEG)(30 minutes of listening to binaural beat signals or sham intervention)
研究者
Vasileios Gkolias
MD, MSc
Aristotle University Of Thessaloniki