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

University Hospital Basel

Status: Completed

Conditions: Itch

Treatments: Other: beddings with cooling effects; Other: commonly used bedding

Study type: Interventional

Funder types: Other

Identifiers

NCT05460598

2022-00160 th21Mueller2;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups, including a placebo group

interventional group: beddings with cooling effects

Active Comparator group

Description:

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.

Treatment:

Other: beddings with cooling effects

control group: commonly used bedding

Placebo Comparator group

Treatment:

Other: commonly used bedding