The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- improvement in (nocturnal) itch
研究概览
简要总结
This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch.
The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.
详细描述
Itch is the most common skin-related symptom. Staying/sleeping in a bed with a cooling properties could have a positive effect on (nocturnal) itch intensity, sleep quality and daytime performance in consequence. A mattress topper and bed linen with cooling effects that are commercially available (https://www.oba.ch/cool\_gel\_topper) by the OBA AG (Basel), which is the supplier of beds and bedding items of the University Hospital Basel, has been used in clinical routine. This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch and to better rationalize the beddings 'use. No comparative data is available and the design is purely exploratory. The primary objective of this study is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
single-blinded (only patients blinded)
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
- •Mean itch intensity NRS > 5 in the past 3 days
- •Literacy and ability to read
- •Inpatient stay required for > 3 nights
排除标准
- •Age < 18 years
- •Illiteracy
- •Cognitive impairment (exclusion in case of mild cognitive impairment according to the Montreal-Cognitive Assessment (MOCA))
- •The duration of the hospitalisation is foreseen to be shorter than 3 days
- •Para- and Tetraplegia
- •Hemisensory syndrome
- •Core body temperature >38°C
- •Use of other bedding > 8 hours or 2nd time request
- •Use of an occlusive therapy
结局指标
主要结局
improvement in (nocturnal) itch
时间窗: NRS ratings will be assessed every 6 hours (throughout 72 hours)
improvement in (nocturnal) itch as measured by the 0-10 Numeric rating Scale (NRS) (at least 2 NRS points per 24 hours to obtain a meaningful therapeutic benefit). (NRS, 0= no itch, 10= worst imaginable)
次要结局
- Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality(Assessment after each night (3 times, altogether 72 hours))
- Patient questionnaire regarding cooling intensity(One time assessment after the third night)
- Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist(Continuously recorded throughout 72 hours)
- Patient questionnaire (regarding lying comfort, cooling pleasantness)(One time assessment after the third night)
- Staff questionnaire regarding time practicability(Assessment after staff shift (3 times, altogether 72 hours))
- Vital signs measured by Fitbit tracker(Continuously recorded throughout 72 hours)