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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
15
beddings with cooling effects (mattress topper and bed linen)
commonly used bedding
Department of Dermatology, University Hospital Basel
Basel, Switzerland
improvement in (nocturnal) itch
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)
Time frame: NRS ratings will be assessed every 6 hours (throughout 72 hours)
Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist
Comparison of the actigraphy of the interventional versus control group.to record hand movements as a surrogate marker for scratching activity and to record sleep tracking functions.
Time frame: Continuously recorded throughout 72 hours
Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality
Sleep quality assessment by RCSQ. It consists of six items addressing "Sleep depth", "Sleep latency", "Awakenings", "Returning to sleep", "Sleep quality" and "Noise", each of which is rated on a visual analogue scales ranging from 0-100 mm. A higher value of the average score represents better sleep.
Time frame: Assessment after each night (3 times, altogether 72 hours)
Patient questionnaire (regarding lying comfort, cooling pleasantness)
Patient questionnaire regarding lying comfort, cooling pleasantness (5-point Likert scales, items "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree")
Time frame: One time assessment after the third night
Patient questionnaire regarding cooling intensity
Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling).
Time frame: One time assessment after the third night
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Staff questionnaire regarding time practicability
Staff questionnaire regarding time practicability (putting on/of the linen, weight of topper, cleaning procedure of cooling beddings) (5-point Likert scales: "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree") after their shift.
Time frame: Assessment after staff shift (3 times, altogether 72 hours)
Vital signs measured by Fitbit tracker
On the non-dominant wrist, patients will wear a tracker (Fitbit Charge 5, Fitbit LLC, USA) to capture vital signs (e.g. heart rate, respiratory rate and skin temperature).
Time frame: Continuously recorded throughout 72 hours