Evaluation of the effect of music therapy on perioperative stress in patients undergoing elective lower limb surgery under regional anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Decrease in perioperative stress
研究概览
简要总结
This is randomised control trial to evaluate the effect of music therapy on perioperative stress in patients undergoing elective lower limb surgery under regional anaesthesia. The primary outcome being decrease in serum cortisol levels in the post operative period in patients who have recieved music therapy. Secondary outcome being stable hemodynamic parameters intraoperatively and post operatively decrease in sedative and anxiolytic requirement intraoperatively decrease in perioperative anxiety and postoperative delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Those undergoing elective lower limb surgery belonging to ASA physical status 1 and 2.
排除标准
- •Known cognitive impairment and language difficulty Known auditory and hearing concerns Patient on psychotropic medications Any problem with the placement of headphones.
结局指标
主要结局
Decrease in perioperative stress
时间窗: Vital parameters before anaesthesia or music therapy that is baseline. | Intraoperative, every 2min for first 10minutes, every 10 minutes for the next 30 minutes and every 15 minutes till the end of the procedure | Postoperatively within 1 hour of surgery
次要结局
- Decrease in sedative & anxiolytic requirement(Every 2 minutes for the first 10 minutes)
- Decrease in anxiety(Before anaesthesia)
- Decrease in delirium(Postoperatively within 1 hour of surgery)
- Stable hemodynamic parameters(Every 2 minutes for the first 10 minutes every 10 minutes for the next 30 minutes & every 15 minutes until the end of surgery)
研究者
SPOORTHI RAO
VMMC AND SAFDARJUNG HOSPITAL