CTRI/2018/02/011895尚未招募不适用
To assess the effect of preoperative melatonin and music on anxiety and recovery profile in patients undergoing day care surgery: A randomized control trial.
Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2018年2月20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
- 99
- 试验地点
- 1
- 主要终点
- To compare preoperative anxiety in melatonin music and placebo groups
研究概览
简要总结
A randomized control study to Assess the effect of Preoperative melatonin and music on Anxiety and Recovery profile in patients undergoing day care surgery.
The anxiolytic properties of melatonin and music distinguish them as a better choices for premedication to reduce preoperative anxiety in day care patients.
99 adults patients will be enrolled in this study. They will be allocated in three groups Melatonin , Music and Placebo.
Study period: one year
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and 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
- •ASA I and ASA II patients undergoing day-care surgery under general anesthesia.
排除标准
- •1.Patients refusal to participate in the study 2.Patients taking analgescis, sedatives, anti-depressant agents.
- •3.History of allergy to study drugs 4.Patients requiring hearing aid 5.Patients having history of any surgery or previous exposure to anesthesia.
- •6.Diabetic patients.
结局指标
主要结局
To compare preoperative anxiety in melatonin music and placebo groups
时间窗: 1. baseline (as soon as patient is received in preoperative area) | 2. Postintervention (5 min prior to shifting the patient to operation theatre)
次要结局
- To compare incidence of emergence agitation using Richmond Agitation-sedation scale .(First 4 hrs in postoperative period)
- postoperative pain scores and rescue analgesics requirement(First 4hrs in postoperative period.)
- Incidence of postoperative nausea and vomiting and requirement of rescue agents(First 4hrs in postoperative period.)
- Time to attain Modified Aldrette Score 9(6 hr)
- Patient satisfaction score(At the time of discharge)
- Postoperative anxiety score(When Aldrette score will be more than 9)
研究者
研究点 (1)
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