The Effect of Music Over the Tolerance to Colonoscopy ¿Does it Reduce the Discomfort, the Anxiety and the Need of Sedation? Multicentric Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- The administered dose of midazolam
研究概览
简要总结
This study will evaluate the efficacy of music (a very well selected list of songs)on improving the tolerance to the colonoscopy. The patients will be randomly assigned to receive music or not. The authors hypothesis is that music is able to improve the tolerance to colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain experimented during the procedure and a reduction of the administered dose of midazolam during the colonoscopy.
详细描述
To select the music that will be administered on this trial we will performed as the first part of the study, a two fase pilot study. In the first part, five song belonging to different musical styles (Rock, Bosa Nova, Classical Music, Popular chilean music and New age) will be heard by 40 persons and the main emotion produced by every song will be registered (chosen among a previously defined list of emotions) and then rated using a visual analog scale. Thus, we will be able to select the musical style that with more frequency produce "tranquility and/or peace". Once this musical style will be selected we generate a set of songs belonging to this style. This set of songs will be validated using again a similar methodology in the second part of the pilot study to be sure that is able to produce the same emotion that the song previously evaluated. The validated set of songs will be the music that will be administered to the patients participating on a multicentric randomized controlled trial where the effect of the selected music over the tolerance to colonoscopy will be evaluated measuring the level of anxiety, the administered dose of midazolam and the intensity of pain experimented during the procedure among another variables on the experimental and the control groups, including 150 patients on each arm.
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
- Single (Care Provider)
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
- •Adults (over 18 years)
- •Diagnostic colonoscopy
- •Signed informed consent
排除标准
- •Hypoacusia
- •Significant cognitive impairment
- •Hypotension
- •Signs of digestive haemorrhage (other than a small amount of rectorrhagia)
- •More than moderate intensity of pain before the colonoscopy.
- •Previous colorectal surgery
- •allergy to midazolam or pethidine
研究组 & 干预措施
Music
A previously defined list of songs will be administered by headphones to these patients during the colonoscopy.
干预措施: Music (Other)
Control
These patients will receive an MP3 device (and headphones) which will be functioning but without volume.
干预措施: No music (Other)
结局指标
主要结局
The administered dose of midazolam
时间窗: After colonoscopy is finished.
The accumulated dose of midazolam administered during the procedure will be registered and compared between both arms.
Level of anxiety
时间窗: rigth before colonoscopy and after it at the moment of discharge
We will use a self-adminsitered questonary (STAI)
次要结局
- Colonoscopy time(During the colonoscopy)
- Time since the beginning of the procedure until the discharge(since the beginning of the procedure until the discharge.)
- Patient's global evaluation of the procedure(after the colonoscopy at the moment of discharge.)
- Willing of repeating the procedure.(After colonoscopy at the moment of discharge)
- How difficult the colonoscopy was?(After the procedure.)
- Adverse effects(Since the begining of the procedure until the discharge.)
- The level of pain(After colonoscopy at the moment of discharge)
- Evolution of vital signs(Rigth before and during the colonoscopy)