Improving Sleep Quality After Total Joint Arthroplasty ( TJA)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effect of melatonin and magnesium on pain
研究概览
简要总结
The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.
详细描述
Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep.
Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental
Melatonin and magnesium for 14 days
干预措施: Melatonin 5 mg (Drug)
Experimental
Melatonin and magnesium for 14 days
干预措施: Magnesium 500Mg Oral Tablet (Drug)
Control
Placebo for 14 days
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Effect of melatonin and magnesium on pain
时间窗: 90 days
Effect of interventions on pain will be measured. It will done at follow up period of 2 wks, 6 wks and 3 months.
次要结局
- Effect of melatonin on daily activities(90 days)
研究者
Derek Amanatullah
Assistant Professor
Stanford University