Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from Baseline in the pressure injury risk will be assessed via the Braden Scale at study completion at day 14. |
The Braden scale assesses a patient's risk of developing a pressure injury by examining the patient's sensory perception related to discomfort or pain caused by pressure. Further, the scale assesses the degree of moisture the skin is exposed to, level of physical activity, the capability and willingness of a patient to adjust the body positioning independently, the nutritional status and the amount of assistance a patient needs to move, as well as the degree of sliding in bed or chair. The total rating of each of these categories gives an indication of the pressure injury risk for the specific person. |
Pressure injury risk assessment will be performed at baseline (day zero) and at study completion at day 14. |
|
Primary |
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. |
Pressure injury assessment will be performed with categorization of any occuring pressure injuries in accordance with the National Pressure Injury Advisory Panel 2019 Guideline, regarding severity of the pressure injury. |
Pressure injury occurence will be assessed from baseline (day zero) and once a day to study completion at day 14. |
|
Secondary |
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. |
Self-assessment will be performed, using the spinal cord injury quality of life basic data set (SCI QoL BDS), with a Likert scale from 0 to 10, where all numbers, including 0 can be used, and where 10 is the best possible health, while 0 is the worst possible. |
Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study conclusion, at day 14. |
|
Secondary |
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. |
Assess the sleep wellness for the past 7 days, using the Insomnia Severity Index (ISI), consisting of seven questions, each with five possible answers going from no problem (0 points) to severe problem (4 points). The seven answers will then be added up, and the total score gives a numeric indication of the sleep wellness, with 0 to 7 points indicating absence of insomnia, 8 to 14 indicating sub-threshold insomnia, 15 to 21 indicating moderate insomnia, and 22 to 28 indicating severe insomnia. |
Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14. |
|
Secondary |
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. |
Assess the participant satisfaction using the mattresses, via a custom made Likert scale, where 1 is completely dissatisfied, and 5 is totally satisfied. |
Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14. |
|
Secondary |
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. |
Assess the staff's satisfaction with the mattress regarding body strain. The assessment will be performed via a custom made Likert scale, where 1 is completely dissatisfied, and 5 is totally satisfied. |
Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14. |
|
Secondary |
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. |
Assess experienced pain, using the the pain intensity part of the Brief Pain Inventory (BPI). The participants will perform a self-assessment of the pain intensity, they experience at the time of assessment, on a 0 to 10 scale where 0 being no pain and 10 being the worst possible pain. |
Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14. |
|
Secondary |
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. |
The interference part of the Brief Pain Inventory (BPI) form will be used. The participants will perform a self-assessment of their pain's interference with functions, regarding general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each of the activities will be scored on a 0 to 10 scale, where 0 being no interference at all, and 10 being the worst possible interference.The pain interference will be scored as the mean of the seven activities assessed. |
Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14. |
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