The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine

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.

Cooling beddings: linen made of the Outlast Technology https://www.outlast.com/en/. This product is made of 100 % lyocell and utilizes phase change materials based on natural wax. When this phase change material melts, heat is extracted from the environment and stored in microcapsules called thermocules. When the body cools down, these thermocules harden again release the heat from the linen. This might help to balances the body temperature and prevent warmth-aggravated itch. - The mattress is made of polyurethane foam and designed as a "cool gel" topper to be placed onto the standard hospital mattress. Heat is also absorbed and stored into this topper. This topper is covered with an Obatex cover. It protects the "cool gel" topper from moisture and organic liquids and is made of polyamide fabric.

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)

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.

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.

Patient questionnaire regarding lying comfort, cooling pleasantness (5-point Likert scales, items "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree")

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.

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).

Inclusion Criteria: Mean itch intensity NRS > 5 in the past 3 days Literacy and ability to read Inpatient stay required for > 3 nights Exclusion Criteria: 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