CTRI/2025/10/095580尚未招募2/3 期
Evaluation of the effect of music therapy on postoperative pain on patients undergoing elective lower segment cesarean section under regional anaesthesia
Vardhaman Mahavir Medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年10月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Postoperative pain levels measured using Numeric Rating Scale (NRS).
研究概览
简要总结
This randomized controlled study will evaluate the effect of music therapy on postoperative pain and perioperative anxiety in women undergoing elective lower segment cesarean section under regional anaesthesia. A total of 104 patients will be randomized into music and no-music groups. Pain (NRS), anxiety (APAIS), hemodynamics, sedative use, and patient satisfaction will be assessed to determine whether music provides a safe, cost-effective, non-pharmacological adjunct for improved perioperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA II patients undergoing elective lower segment cesarean section under regional anaesthesia.
排除标准
- •Patients with hearing impairment, psychiatric illness or anxiety disorder, patients on anxiolytics, antidepressants, or analgesics preoperatively, and patients with contraindication to regional anaesthesia.
结局指标
主要结局
Postoperative pain levels measured using Numeric Rating Scale (NRS).
时间窗: 1 hour 2 hour 4 hour postoperatively
次要结局
- Perioperative anxiety measured using Amsterdam Preoperative Anxiety and Information Scale (APAIS)(Preoperatively and postoperative)
- Hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure, SpO2).(Baseline vitals after wheeling in ot, after administration of regional anaesthesia then at 10 minutes 20 minutes 30 minutes 60 minutes 90 minutes 120 minutes)
- Sedative/anxiolytic and rescue analgesic requirement (number of doses and total consumption — e.g., IV tramadol 50 mg).(Intraoperative and upto 4 hour postoperatively)
- Patient satisfaction measured by 5-point Likert scale(Before discharge from Post anaesthesia care unit)
研究者
Karishma Binyala
Vardhman Mahavir Medical College and Safdarjung Hospital
研究点 (1)
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