Clinical trial NCT05207891: Comparing Pressure Injury Occurrence in Patients Using Two Different Mattresses
Official title: Comparing Two Types of Dynamic Air Mattresses, With Focus on Changes in Pressure Injury Occurrence and Functionality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Sleep
Pain
Satisfaction, Patient
Noise Exposure
Strains
Satisfaction, Personal
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Inclusion, collection of baseline data at day zero, then seven days use of the first mattress and data collection on day seven, new pressure measurement at day seven, seven days use of the second mattress and final data collection after seven days of use of the second mattress. Summarized, the data collection will be at baseline, at day seven and at day 14.
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to compare a newly developed automatic reversing dynamic air mattress, with a regular care mattress, which is in daily use at the hospital. Focus will be on pressure relief in relation to occurrence of pressure injury, user satisfaction, and the mattresses impact on sleep and pain. The participants will be randomized to start with the intervention mattress or the control mattress. Outcomes will be measured via validated forms regarding pressure related injuries, quality of life, pain, and mattress comfort. Custom made forms will be used regarding resource use and comfort in the nursing service, especially in relation to position changes in the participants .

Detailed description: The investigators will conduct a randomized cross over testing, where the purpose is to compare an intervention mattress and a regular care mattress in relation to occurrence of pressure relief, experienced sleep comfort, pain and quality of life in the participants. Further on, the investigators want to examine staff needed to assist in position change of the participants, as well as physical strain for the staff.

To secure safe use of the intervention mattress, a noise-test and a pressure assessment test of the mattresses have been performed in advance of the research project. A pressure limit is defined, based on current evidence based knowledge regarding pressure injury risk. If this limit is exceeded during the project period, the participant will be excluded from further testing, due to a potential increased risk of pressure injury development.

Written and oral information regarding the project will be given, and the participants will give a written concent before inclusion.

The regular care mattress, used as control in this trial, is considered one of the best pressure relieving mattresses available in Norway.

Ten participants will be included and randomized to start with the intervention mattress or the control mattress. Baseline data regarding gender, age, level and severity of the spinal injury, together with pressure injury associated dysfunction, like increased sweat, bladder and bowel incontinency will be collected immediately after inclusion. The investigators will also ask for information of comorbidity previous to the spinal injury, including cardiovascular disease, embolisms or diabetes mellitus.

Pressure monitoring will be performed before start up, and validated questionnaires will be used in assessing pressure injury risk, pain and quality of life. Pressure injury occurrence will be assessed every day. After seven days use of the first mattress, new data will be collected, by means of validated forms regarding pain occurrence, noise from the mattress devices, sleeping wellness and participant satisfaction. Custom made forms regarding resource use in the nursing staff, especially at night and in relation to position change, will be collected, together with data regarding physical strain in the staff.

The participant will then change to the other mattress and pressure monitoring will be performed. If acceptable results, the participant will use this mattress for seven days. Pressure injury occurrence will be assessed every day. Then a end-of-study data assessment will be performed, similar to the questionnaires used in the intervention mattress.

Finally, in-depth interviews will be performed in one participants and one nurse finishing the study on the intervention mattress, and one participant and one nurse finishing the study, using the control mattress.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* SCI, neurological disease with paralysis or multi trauma, all with lack of independency in position change in bed, and hospitalized for primary rehabilitation in either the Spinal Cord Unit (SCU) or the Multi trauma, Neurological disease, Burn (MNB) Unit
* Requires manual position change
* Medically approved for the participation by the participant's physician
* Able to give consent to participate
* Psychically and cognitively able to properly answer the questionnaires
* Speaks/understands Norwegian language

Exclusion Criteria:

* Ongoing pressure injury
* External fixation, except neck collar
* Body weight \> 150 kg
* pre-test pressure assessment above the maximum pressure limit.

Primary outcomes:
measure: Change from Baseline in the pressure injury risk will be assessed via the Braden Scale at study completion at day 14.
timeFrame: Pressure injury risk assessment will be performed at baseline (day zero) and at study completion at day 14.
measure: Change in pressure injury occurence from (day zero), will be assessed, via the National Pressure Injury Advisory Panel 2019 Guideline, once a day to study completion at day 14.
timeFrame: Pressure injury occurence will be assessed from baseline (day zero) and once a day to study completion at day 14.
Secondary outcomes:
measure: Change in Quality of Life (QoL) from baseline, will be assessed via the spinal cord injury quality of Life basic data set (SCI QoL BDS) at day seven, and at day conclusion of the study at day 14.
timeFrame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study conclusion, at day 14.
measure: Change from baseline in the sleep wellness will be assessed via the Insomnia Severity Index (ISI) at day seven and at conclusion of the study at day 14.
timeFrame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
measure: Change in participant satisfaction from baseline, will be assessed via a custom made Likert scale at day seven, and at conclusion of the study at day 14.
timeFrame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
measure: Change in staff satisfaction from baseline, will be assessed via a custom made Likert scale at day seven, and at conclusion of the study at day 14.
timeFrame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
measure: Change in pain intensity from baseline will be assessed via the Brief Pain Inventory (BPI) form at change of mattress at day seven, and at end of study at day 14.
timeFrame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
measure: Change in pain's interference with functions from baseline will be assessed via the Brief Pain Inventory form at day seven and at day 14.
timeFrame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
Other outcomes:
Locations:
city: Nesoddtangen
country: Norway
facility: Sunnaas Rehabilitation Hospital
state: Akershus
Study officials:
affiliation: Sunnaas Rehabilitation Hospital
name: Ingebjørg Irgens, MD
role: PRINCIPAL_INVESTIGATOR
References: