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

NCT05460598 | Completed

• 1 other identifier: 2022-00160; th21Mueller2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Itch

Keywords

cooling beddings; sleep quality; scratching; itch reduction; itch; nocturnal

Outcome Measures

Primary Outcomes (1)

• improvement in (nocturnal) itch

  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)

  NRS ratings will be assessed every 6 hours (throughout 72 hours)

Secondary Outcomes (6)

• Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist

  Continuously recorded throughout 72 hours

• Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality

  Assessment after each night (3 times, altogether 72 hours)

• Patient questionnaire (regarding lying comfort, cooling pleasantness)

  One time assessment after the third night

• Patient questionnaire regarding cooling intensity

  One time assessment after the third night

• Staff questionnaire regarding time practicability

  Assessment after staff shift (3 times, altogether 72 hours)

Study Arms (2)

interventional group: beddings with cooling effects

ACTIVE COMPARATOR

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.

Other: beddings with cooling effects

control group: commonly used bedding

PLACEBO COMPARATOR

Other: commonly used bedding

Interventions

beddings with cooling effects OTHER

beddings with cooling effects (mattress topper and bed linen)

interventional group: beddings with cooling effects

commonly used bedding OTHER

commonly used bedding

control group: commonly used bedding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mean itch intensity NRS \> 5 in the past 3 days
• Literacy and ability to read
• Inpatient stay required for \> 3 nights

You may not qualify if:

• Age \< 18 years
• Illiteracy
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pruritus; Sleep Initiation and Maintenance Disorders

Interventions

Bedding and Linens

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies; Household Articles; Technology, Industry, and Agriculture

Study Officials

• Simon Mueller, PD Dr. med.

  Department of Dermatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded (only patients blinded)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, investigator-initiated, single-blinded, interventional, exploratory study.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 15, 2022
• Study Start: August 1, 2022
• Primary Completion: May 28, 2023
• Study Completion: May 28, 2023
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CH (1)