Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Impact of Music on skin temperature in degrees Celsius
研究概览
简要总结
The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves.
The Null hypothesis: The comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant.
Alternative hypothesis: The comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.
详细描述
In the field of endoscopy, stress and pain play a relevant role before and during the examination. A variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. Especially the use of relaxation music. However, the previous studies refer to a subjective assessment of the participants after the examination. Here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. Pain reactions express themselves explicitly in autonomous function. In contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction.
The activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface:
- in the face area (corrugator, zygomaticus)
- on the hand (skin conductance, temperature)
- on the torso (electrocardiogram) The satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Indication for colonoscopy
- •conscious sedation with propofol
- •ASA state 1 or 2
排除标准
- •lack of written informed consent
- •pregnancy
- •General anaesthetics
- •ASA state >2
- •deafness, Hearing impairment
结局指标
主要结局
Impact of Music on skin temperature in degrees Celsius
时间窗: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on skin conductance in micro Siemens
时间窗: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on Propofol Dosis in millilitres
时间窗: During colonoscopy procedure
Evaluation of sedation requirements for the objective operationalization of stress reduction
Impact of Music on procedure time in minutes
时间窗: During colonoscopy procedure
Evaluation of examination time for the objective operationalization of stress reduction
Endoscopist satisfaction by means of questionnaire
时间窗: immediately after colonoscopy was finished
Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)
时间窗: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on EKG (heart rate, heart rate variability)
时间窗: During colonoscopy procedure
Evaluation of biopotential signals for the objective operationalization of stress reduction
Patient satisfaction with endoscopical procedure by means of questionnaire
时间窗: Approximately 45 minutes after colonoscopy was finished
Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)
Patient satisfaction with sedation by means of questionnaire
时间窗: Approximately 45 minutes after colonoscopy was finished
Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
次要结局
未报告次要终点
研究者
Thomas Seufferlein
Professor, Head of Department
University of Ulm