Weighted Blankets and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Change in pain ratings from before to after nightly blanket use
研究概览
简要总结
The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •18 years or older
- •Fluent in English
- •Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org)
- •Willing to sleep with a weighted blanket and fitness watch for 1 week
- •Able to safely lift up to 15lb
- •Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan
排除标准
- •Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder)
- •Current or previous use of a weighted blanket
- •Claustrophobia
结局指标
主要结局
Change in pain ratings from before to after nightly blanket use
时间窗: at baseline (3 nights) and over 7 nights of use
Pain ratings will be compared before and after 1 week of nightly use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse).
Change in pain ratings from before to after brief blanket use
时间窗: 0 and 15 minutes
Pain ratings will be compared before and after use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse).
次要结局
- Change in anxiety ratings from before to after brief blanket use(0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use)
- Change in ratings of sleep quality from before to after brief blanket use(baseline (3 nights) and over 7 nights of use)
- Change in sleep quality measured by fitness watch from before to during week of blanket use(baseline (3 nights) and over 7 nights of use)
研究者
Laura Case
Assistant Professor
University of California, San Diego