Effects of Ascending Warm Footbaths on Sleep Disturbances in Women Before Climacteric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change of sleep quality
研究概览
简要总结
The purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Minimum age: 18 years
- •Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month)
排除标准
- •secundary sleeping disease
- •Mental diseases which require therapy
- •Medication: benzodiazepine,Z-drugs, barbiturat, antihistaminika, melatonin
- •Severe comorbidity
- •Gravidity
- •Shift work
- •Voyages (>3 times during the study)
- •regulary application of Kneipp
- •Participation on other studies to therapy sleeping diseases or stress
研究组 & 干预措施
Footbath, care of sleep
Warm water (37°C) filled up to the level of the ankle. Water has to be heated up to 42°C and increased to the calf 's half height within 15 minutes.
Information about wrong and correct behaviour.
干预措施: footbath (Procedure)
Footbath, care of sleep
Warm water (37°C) filled up to the level of the ankle. Water has to be heated up to 42°C and increased to the calf 's half height within 15 minutes.
Information about wrong and correct behaviour.
干预措施: care of sleep (Behavioral)
Care of sleep
Information about wrong and correct behaviour.
干预措施: care of sleep (Behavioral)
结局指标
主要结局
Change of sleep quality
时间窗: T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization
Use Pittsburgh sleep quality index
次要结局
未报告次要终点
研究者
Petra Klose
Director
Universität Duisburg-Essen