Evaluation of Pain and Patient Satisfaction Using Binaural Beats in Patients Submitted to Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain perception evaluated with VAS
研究概览
简要总结
Investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy .
详细描述
Colonoscopy is a disturbing and painful procedure, so whenever possible it is performed in sedation. Although the use of sedative drugs is effective in relieving anxiety and pain such drugs can cause significant side-effects.
This study examines the effect of Binaural Beats stimulation on pain perception during colonscopy.
Binaural Beats is a simple technique, described for the first time since by Gerald Oster , that include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies.
These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .
Binaural Beats have already been used in humans undergoing outpatient surgery in urogynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery . In this study the investigators evaluate the use of Binaural Beat in outpatients to undergo colonoscopy to reduce pain .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for outpatient colonoscopy
- •Valid consent expression to the study participation
- •Good collaboration in activities provided by the study
排除标准
- •Insufficient degree of collaboration
- •Abnormal hearing
- •Denial of informed consent to participate in the study
- •Previous colon resection surgery
结局指标
主要结局
Pain perception evaluated with VAS
时间窗: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)
Comparison between the two groups of pain perceived during the procedure by VAS scale. The Visual Analogue Scale (VAS) is a validated scale for measuring pain on 11 points, from 0 to 10, in which the patient indicates the maximum perceived pain.
次要结局
- Blood pressure assessment(3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope);)
- comparison on the number of subjects who could not complete the exam(at the end of the planned study in a year)
- Comparison between the two groups of the level of satisfaction: Likert scale(5 minutes after completing the procedure (complete withdrawal of the colonoscope))
- Heart rate assessment(3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope);)
- comparison on the use of drugs during the procedure(at the end of the planned study in a year)
研究者
Alessandro Tani
Principal Investigator
Azienda USL Toscana Nord Ovest