Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Change in anxiety ratings from before to during blanket use before surgery
研究概览
简要总结
The strongest psychological predictor of persistent pain after surgery is anxiety before surgery. The weight of blanket a person uses overnight may alter both anxiety and pain levels. The proposed study will determine whether a heavier or lighter blanket alters presurgical anxiety or postsurgical pain in individuals undergoing a breast surgery. We will also study whether any blanket-induced changes in postsurgical pain are related to reductions in anxiety before surgery induced by the blanket. Finally, we will examine clinical and psychological factors that might explain differences in how surgical patients respond to blanket weight. This research will improve our understanding of whether blanket weight can alter anxiety before a surgery or pain after a surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Partial masking: Although blanket heaviness will be perceived, blanket weights tested in the study will not be disclosed to participants. Wait-list control group will know they are not receiving active intervention.
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
- •Fluent in English
- •Undergoing breast surgery
- •Willing to sleep with a weighted blanket for up to 3 months
- •BMI of at least 18.5 and able to safely lift up to 15lb
- •Willing and able to use their personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan
排除标准
- •Pregnancy
- •Chronic high-dose opioid use
- •Current or previous use of a weighted blanket
- •Claustrophobia
- •Incarceration
研究组 & 干预措施
Waitlist control
No blanket will be provided until the end of the study; participants will sleep with their normal bedding.
Heavier blanket
A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
干预措施: Weighted blanket (Device)
Lighter blanket
A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
干预措施: Weighted blanket (Device)
结局指标
主要结局
Change in anxiety ratings from before to during blanket use before surgery
时间窗: arrival to surgical center and final rating prior to surgery
Anxiety ratings will be compared before and during use of weighted blanket on the following scale: "Extremely anxious" to "Neutral" to "Extremely calm"
Change in postsurgical pain from before to after overnight blanket use
时间窗: baseline (before surgery) and 1 and 3 months after surgery
Brief Pain Inventory score will be compared before and after overnight use of assigned blanket
Change in medication use from before to after overnight blanket use
时间窗: baseline (before surgery) and 1 and 3 months after surgery
Medications taken in past 24 hours will be self-reported
次要结局
- Change in medication use from before to after overnight blanket use(baseline, 1 week, 1 month, and 3 months)
- Change in postsurgical pain from before to after overnight blanket use(baseline, 1 week, 1 month, and 3 months)
研究者
Laura Case
Adjunct Professor
University of California, San Diego