Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.
详细描述
Primary Objective:
To determine the feasibility of using weighted blankets to improve Sleep Disturbances (SD) for patients with hematological malignancies in an outpatient setting.
Secondary Objectives:
To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question. A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 +/-2 days.
To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index (ISI) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Outpatient at MD Anderson Cancer Center
- •Adult patients ≥ 18 years
- •Diagnosis of hematological malignancy
- •ESAS Sleep>/=4
- •Performance status as measured by Eastern Cooperative Oncology Practice group (ECOG) score of 2 or below
排除标准
- •Platelet count of 25 or below
- •History of seizures/intracranial metastasis/ sleep apnea/restless leg syndrome/paralysis
- •Weight less than 150 lbs.
- •Attending physician assessment of prognosis with expected life expectancy of <1 month
- •Patients who are unable to tolerate their blankets/sheets in the night due to medical conditions such as pain, peripheral neuropathy, night sweats, hot flashes etc.
- •Patients with difficulty breathing, disorders of poor circulation, fragile skin, rash, or open wounds, or by those who are claustrophobic or cleithrophobic.
- •Prior use of weighted blankets within the past 1-year
研究组 & 干预措施
Patients more than 200 pounds
干预措施: Weighted Blanket (Other)
Patients between 150-200 pounds
干预措施: Weighted Blanket (Other)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点