Evaluation of the persistency of the preoperative anxiolytic effect of music therapy vs midazolam: electroencephalographic and clinical analysis
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia
概览
简要总结
To evaluate the persistence of the preoperative anxiolytic effect of music therapy versus midazolam using electroencephalographic and clinical analysis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who have been scheduled for surgery and have agreed to give informed consent for the study.
排除标准
- •Refusal to be part of the study on a voluntary basis
- •Patients who report dissatisfaction with music therapy
- •Severe hearing loss
- •A patient condition that impairs the ability to comprehend the study information.
- •A history of allergic reactions to benzodiazepines
- •Conditions in which benzodiazepine use is not recommended, such as severe obstructive apnea, morbid obesity, or other relevant conditions considered by an anesthesiologist.
结局指标
主要结局
Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia
Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia
Scales to measure anxiety:“Preoperative Anxiety and Information Scale (APAIS), The Hospital Anxiety Depression Scale (HADS) and Visual Analogue anxiety Scale (VAS)
Scales to measure anxiety:“Preoperative Anxiety and Information Scale (APAIS), The Hospital Anxiety Depression Scale (HADS) and Visual Analogue anxiety Scale (VAS)
次要结局
- Processed EEG (BIS index), blood pressure, heart rate and oxygen saturation, demographics, surgery type (ambulatory vs. admitted patient), adverse effects, chronic use prescriptions
研究者
Hospital del Mar
Scientific
Consorci Mar Parc De Salut De Barcelona