Comparison Between Music Therapy and Intravenous Midazolam 0,02 mg/kgBW in Reducing Preoperative Anxiety: Study on Patient Undergoing Brachytherapy With Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- APAIS score
研究概览
简要总结
This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia
详细描述
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula had been set and The Amsterdam Preoperative Anxiety and Information (APAIS) score questionnaire was filled by the subject. Blood pressure, pulse rate, and mean arterial pressure were recorded. Subjects were then randomized into two groups (music therapy and midazolam). In music therapy group, subjects listened to music using headphone attached to music player for 30 minutes. Music player has been filled with variety of slow beat songs (60 - 80 BPM), including instrumental, pop, jazz, classical, and so forth. In midazolam group, subjects was given intravenous midazolam 0,02 mg/kgBW injection without listening to music. After injection, subjects are allowed to rest or sleep for 30 minutes. After intervention, APAIS score was filled by subjects with blood pressure, pulse rate, and mean arterial pressure recorded again. Subjects then were moved to brachytherapy room.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman aged 18-65 years old
- •Undergoing one day care brachtherapy with spinal anesthesia
- •American Society of Anesthesiologist (ASA) physical status of I-III
- •Agreed to participate in this study and signed informed consent
- •Able to read, write, and speak in Indonesian language.
排除标准
- •Subjects with severe hearing impairment
- •Subjects with cognitive/mental impairment based on medical record
- •Subjects with previous routine use of antipsychotic and benzodiazepine drug
- •Subjects with prior heart disease or uncontrolled hypertension.
研究组 & 干预措施
Music therapy
干预措施: Music therapy (Other)
Midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
APAIS score
时间窗: Day 1
Pulse rate
时间窗: Day 1
Blood pressure
时间窗: Day 1
Mean Arterial Pressure
时间窗: Day 1
次要结局
未报告次要终点
研究者
Christopher Kapuangan
Anesthesiologist
Indonesia University
