Clinical trial NCT05460598: The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine
Official title: The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch
Keywords: cooling beddings
sleep quality
scratching
itch reduction
itch; nocturnal
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, investigator-initiated, single-blinded, interventional, exploratory study.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: improvement in (nocturnal) itch
timeFrame: NRS ratings will be assessed every 6 hours (throughout 72 hours)
Secondary outcomes:
measure: Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist
timeFrame: Continuously recorded throughout 72 hours
measure: Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality
timeFrame: Assessment after each night (3 times, altogether 72 hours)
measure: Patient questionnaire (regarding lying comfort, cooling pleasantness)
timeFrame: One time assessment after the third night
measure: Patient questionnaire regarding cooling intensity
timeFrame: One time assessment after the third night
measure: Staff questionnaire regarding time practicability
timeFrame: Assessment after staff shift (3 times, altogether 72 hours)
measure: Vital signs measured by Fitbit tracker
timeFrame: Continuously recorded throughout 72 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Mueller, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: