CTRI/2024/09/074055尚未招募不适用
Comparison of effect of music therapy alone or with intravenous midazolam on pre-operative anxiety in adult patients undergoing laparoscopic cholecystectomy
Dr Gijo Paul1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- APAIS SCORE
研究概览
简要总结
This is a randomized control study comparing three techniques to decrease pre operative anxiety using:
(i) Music therapy
(ii) Intravenous midazolam
(iii) combination of music therapy and intravenous midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of anesthesiologists Grade I and II Elective laparoscopic cholecystectomy surgical procedure requiring general anesthesia Patients with informed consent.
排除标准
- •Patient refusal History of allergy to midazolam Patients with cardiovascular diseases Patients with known respiratory disease Patients with significant hepatic and/ or renal dysfunction Patients suffering from any psychiatric disorder Deaf or hearing-impaired patients Pregnant and lactating patients.
结局指标
主要结局
APAIS SCORE
时间窗: baseline | 20 minutes
次要结局
- To establish efficacy of music therapy and midazolam on:(Hemodynamics- Heart Rate and Blood Pressure)
研究者
Dr Gijo Paul
The Mission Hospital
研究点 (1)
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