Itch
Conditions
Keywords
cooling beddings, sleep quality, scratching, itch reduction, itch; nocturnal
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.
Interventions
OTHERbeddings with cooling effects
beddings with cooling effects (mattress topper and bed linen)
OTHERcommonly used bedding
commonly used bedding
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
single-blinded (only patients blinded)
Intervention model description
Single-center, investigator-initiated, single-blinded, interventional, exploratory study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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). |
| Patient questionnaire regarding cooling intensity | One time assessment after the third night | Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling). |
Countries
Switzerland
Outcome results
None listed