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

NCT ID: NCT05460598

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-05-28

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.

Conditions

Itch

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

interventional group: beddings with cooling effects

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.

Group Type: ACTIVE_COMPARATOR

beddings with cooling effects

Intervention Type: OTHER

beddings with cooling effects (mattress topper and bed linen)

control group: commonly used bedding

Group Type: PLACEBO_COMPARATOR

commonly used bedding

Intervention Type: OTHER

commonly used bedding

Interventions

beddings with cooling effects

beddings with cooling effects (mattress topper and bed linen)

Intervention Type: OTHER

commonly used bedding

commonly used bedding

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Mueller, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital Basel

Locations

Department of Dermatology, University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2022-00160; th21Mueller2

Identifier Type: -

Identifier Source: org_study_id