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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05460598

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Itch	Other: beddings with cooling effects Other: commonly used bedding	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

single-blinded (only patients blinded)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

improvement in (nocturnal) itch [NRS ratings will be assessed every 6 hours (throughout 72 hours)]
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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