NCT04590742Unknown不适用
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Patient Sleep Quality
研究概览
简要总结
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty
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
- None
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
- 是
入选标准
- •Patients who undergo unilateral primary total joint arthroplasty
- •Patient willing and able to complete postoperative surveys
排除标准
- •Patients who undergo revision total joint arthroplasty
- •Patients who undergo bilateral total joint arthroplasty
- •Patients currently taking melatonin supplementation
- •Patient has history of substance abuse (drug or alcohol)
- •Patient is a workman's comp patient or patient has current litigation pending
- •Patient has an allergy to melatonin
- •Patient has a history of delirium/psychiatric/depression/on antidepressants
- •Patient has a history of insomnia/ on sleep aid medication
- •Anyone on warfarin
- •Sleep apnea
- •Patient discharged to SNF or rehab
- •Patients who have inflammatory conditions
- •Shift work or night work
研究组 & 干预措施
Group 1
Placebo Comparator
Placebo Tablet
干预措施: Placebo (Drug)
Group 2
Active Comparator
Melatonin (6mg)
干预措施: melatonin 6mg (Drug)
结局指标
主要结局
Patient Sleep Quality
时间窗: 6 weeks
Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires
次要结局
未报告次要终点
研究者
研究点 (1)
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