Comparing Two Types of Dynamic Air Mattresses, With Focus on Changes in Pressure Injury Occurrence and Functionality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking. This will be an open label study, because it will be impossible to mask the mattresses due to different lay-out and function.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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
排除标准
- •Ongoing pressure injury
- •External fixation, except neck collar
- •Body weight > 150 kg
- •pre-test pressure assessment above the maximum pressure limit.
结局指标
主要结局
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.
时间窗: Pressure injury occurence will be assessed from baseline (day zero) and 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.
Change from Baseline in the pressure injury risk will be assessed via the Braden Scale at study completion at day 14.
时间窗: Pressure injury risk assessment will be performed at baseline (day zero) and 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.
次要结局
- 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.(Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.)
- 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.(Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.)
- 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.(Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.)
- 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.(Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study conclusion, at day 14.)
- 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.(Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.)
- 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.(Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.)