Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean Change in Pittsburgh Sleep Quality Index Score
研究概览
简要总结
The purpose of the study is to test the efficacy of sleep treatment in human patients following traumatic injury. Specifically, the study will determine if treatment consisting of melatonin and education related to sleep habits are effective in treating sleep disturbance and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and sleep education effectively improve sleep following traumatic injury, and improve outcomes.
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
- Double (Participant, Care Provider)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New patients visiting the Orthopaedic Trauma Clinic or undergoing orthopaedic surgery in Stanford Hospital following traumatic injury. Accidental traumatic fracture injuries that are operative and non-operative. Must be able to swallow tablets.
排除标准
- •Documented head trauma. Cognitive impairments. Minors. Previously diagnosed sleep disorders. Sleep apnea. Enrolled in another study. Women who are pregnant or may become pregnant or are nursing. Hypertension. Diabetes. Endocrine, autoimmune, depressive, bleeding or seizure disorders.
结局指标
主要结局
Mean Change in Pittsburgh Sleep Quality Index Score
时间窗: Baseline, week 6, and week 12
9-item self-rated questionnaire that assesses clinical sleep quality and disturbances. Global PSQI scores are sums of the component scores, and range from 0-21. Higher scores indicate worse sleep quality.
次要结局
- 36-Item Short Form Survey (SF-36) to measure quality of life(Baseline, week 6, and week 12)
- Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)(Baseline, week 6, and week 12)
研究者
Michael J. Gardner
PROFESSOR OF ORTHOPAEDIC SURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER
Stanford University