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

Not Applicable

Completed

• Conditions: Itch

• Registration Number: NCT05460598
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-15
• Study Start: 2022-08-01
• Primary Completion: 2023-05-28
• Study Completion: 2023-05-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
improvement in (nocturnal) itch	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)

Secondary Outcome Measures

Name	Time	Method
Patient questionnaire regarding cooling intensity	One time assessment after the third night	Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling).
Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality	Assessment after each night (3 times, altogether 72 hours)	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.
Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist	Continuously recorded throughout 72 hours	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.
Patient questionnaire (regarding lying comfort, cooling pleasantness)	One time assessment after the third night	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	Assessment after staff shift (3 times, altogether 72 hours)	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.
Vital signs measured by Fitbit tracker	Continuously recorded throughout 72 hours	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).

Trial Locations

Locations (1)

Department of Dermatology, University Hospital Basel; 🇨🇭 Basel, Switzerland