Anxiety, Preoperative Stress and Music Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cardiac monitoring
研究概览
简要总结
Music can reduce anxiety in adult patients awaiting surgical interventions. The study was designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory enzymes, skin resitance between surgical patients listening music vs no sound.
详细描述
Patients undergoing elective surgical intervention will be allocated in two groups: Group M will listen prerecorded music through an individual headset for 30 min before the induction of anesthesia; Group C will listen no sound through an individual headset for 30 min before the induction of anesthesia The degree of stress and anxiety the patients will be assessed using questionnaire. Laboratory enzymes will be measured.
Heart rate, non invasive arterial pressure, pulse oximetry,skin resistance will be recorded. All the patients will receive continuous ECG holter recording .
To assess the effect of music therapy on the degree of autonomic modulation, HRV will be analyzed with traditional time and frequency measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Elective surgical patients >18 years old, after obtaining informed consent
排除标准
- •patients with hearing impairment,
- •any known psychiatric or memory disorder
- •thyroid disease.
- •atrial fibrillation
- •pace-maker
研究组 & 干预措施
Music therapy
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
干预措施: questionnaire (Diagnostic Test)
Music therapy
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
干预措施: laboratory test (Diagnostic Test)
Music therapy
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
干预措施: cardiac monitoring (Diagnostic Test)
Music therapy
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
干预措施: skin resistance (Diagnostic Test)
Music therapy
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
干预措施: Music listening (Device)
Control
patients wear headphones for 30 minuts without any sound
干预措施: questionnaire (Diagnostic Test)
Control
patients wear headphones for 30 minuts without any sound
干预措施: laboratory test (Diagnostic Test)
Control
patients wear headphones for 30 minuts without any sound
干预措施: cardiac monitoring (Diagnostic Test)
Control
patients wear headphones for 30 minuts without any sound
干预措施: skin resistance (Diagnostic Test)
Control
patients wear headphones for 30 minuts without any sound
干预措施: No sound (Device)
结局指标
主要结局
cardiac monitoring
时间窗: through study period (to 15 min before the application of headphones until 15 minutes after their removal
cardiac variability
次要结局
- questionnaire(questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones))
- laboratory test(enzyme level change early after the application of headphones from baseline (early before the application of headphones))
研究者
Cotoia Antonella
Aggregate Professor, PhD
University of Foggia