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

Itch Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05460598
• Other study ID #: 2022-00160; th21Mueller2
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Itch
• Pruritus

Intervention

Other:
• beddings with cooling effects
beddings with cooling effects (mattress topper and bed linen)
• commonly used bedding
commonly used bedding

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	Patient questionnaire regarding cooling intensity	Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling).	One time assessment after the third night
Secondary	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)
Secondary	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