CTRI/2019/04/018842尚未招募不适用
Role of music on perioperative anxiety in patients undergoing surgeries under spinal anaesthesia.
GGS Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月5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
- 70
- 试验地点
- 1
- 主要终点
- Anxiety by Visual Analogue scale for Anxiety
研究概览
简要总结
This study is a randomized prospective trial to compare the role of music on perioperative anxiety with standard OT noise for 18 months in 70 patients undergoing surgeries under spinal anaesthesia. The primary outcome measure will be anxiety- preoperative, intraoperative and postoperative. The secondary outcome measure will be patient satisfaction at 24 hours and haemodynamic parameters- intraoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator 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
- •Patients undergoing elective surgeries under spinal anaesthesia.
- •ASA (American Society of Anaesthesiologists) grade I and II.
- •Age group 18-60 years of either gender, giving valid informed and written consent.
排除标准
- •Unwillingness to participate in the study (no consent).
- •ASA grade III and IV patients.
- •Patients with any contra-indication to spinal anaesthesia.
- •Patients with hearing impairment.
- •Known psychiatric or memory disorder.
结局指标
主要结局
Anxiety by Visual Analogue scale for Anxiety
时间窗: Pre-operative,Intra-operative,Post-operative
次要结局
- Patient satisfaction by Patient Satisfaction score(At 24 hours)
- Hemodynamic parameters(Intra-operative)
研究者
研究点 (1)
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