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

The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Itch
• Intervention / Treatment: Other: beddings with cooling effects; Other: commonly used bedding

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Dermatology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: beddings with cooling effects; beddings with cooling effects (mattress topper and bed linen)
Placebo Comparator: control group: commonly used bedding	Other: commonly used bedding; commonly used bedding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist	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.	Continuously recorded throughout 72 hours
Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality	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.	Assessment after each night (3 times, altogether 72 hours)
Patient questionnaire (regarding lying comfort, cooling pleasantness)	Patient questionnaire regarding lying comfort, cooling pleasantness (5-point Likert scales, items "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree")	One time assessment after the third night
Patient questionnaire regarding cooling intensity	Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling).	One time assessment after the third night
Staff questionnaire regarding time practicability	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.	Assessment after staff shift (3 times, altogether 72 hours)
Vital signs measured by Fitbit tracker	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).	Continuously recorded throughout 72 hours

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Simon Mueller, PD Dr. med., Department of Dermatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 28, 2023
• Study Completion (Actual): May 28, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: sleep quality; scratching; cooling beddings; itch reduction; itch; nocturnal
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: 2022-00160; th21Mueller2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No