Comparing Pressure Injury Occurrence in Patients Using Two Different Mattresses

• ClinicalTrials.gov Identifier: NCT05207891
• Recruitment Status: Completed
• First Posted: January 26, 2022
• Last Update Posted: April 14, 2023
• Sponsor: Sunnaas Rehabilitation Hospital
• Information provided by (Responsible Party): Sunnaas Rehabilitation Hospital

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Pressure Injury; Sleep; Pain; Satisfaction, Patient; Noise Exposure; Strains; Satisfaction, Personal	Device: Intervention mattress	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: None (Open Label)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Comparing Two Types of Dynamic Air Mattresses, With Focus on Changes in Pressure Injury Occurrence and Functionality
• Actual Study Start Date: September 14, 2021
• Actual Primary Completion Date: March 1, 2023
• Actual Study Completion Date: March 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention mattress; At every shift during the seven days project period, the nurses will check for pressure wounds, and mark identified pressure wounds and their category on a pressure injury body map. At every shift the nurses will use a custom made form to register resources needed in each position changing of the patient, the number of times the position is changed, as well as the level of physical strain in the nurses. All participants will start with seven days use of the newly developed intervention mattress. At the end of the testing period, the participants will register their feeling of quality of life, bedrest comfort, sleep-wellness, pain and satisfaction in the study period. A custom made semi-structured interview guide has been conducted asking in more details of experienced quality in use and in managing the mattress. One participant and one nurse will be asked to participate in in-depth interviews after testing both mattresses.	Device: Intervention mattress; The intervention mattress, Tidewave, will be compared to the regular care mattress, CuroCell 4AD. Primary outcome will be change in pressure injury occurence, assessed according to the NPIAP 2019 Clinical Guidance, and marked up on pressure injury body-map figures. Secondary outcomes will be experienced quality of life, assessed with the Spinal Cord Injury Quality of Life Basic Data Set. Further mattress comfort, assessed with the Mattress Comfort Scale, sleep-wellness, assessed with the Insomnia Severity Index, and pain, assessed with the Brief Pain Inventory. Satisfaction in the participants and in the nursing staff will be assessed with custom made Likert scales. Resource use and experienced stain in the nursing staff will be assessed with custom made forms asking for number of persons needed in position change, number of position changes needed during bed-rest, and experienced strain related to the position changes.; Other Name: Tidewave
No Intervention: Regulare care mattress; At every shift during the seven days project period, the nurses will check for pressure wounds, and mark identified pressure wounds and their category on a pressure injury body map. At every shift the nurses will use a custom made form to register resources needed in each position changing of the patient, the number of times the position is changed, as well as physical strain in the nurses. At the end of the testing period, the participants will register their feeling of quality of life, bedrest comfort, sleep-wellness, pain and satisfaction in the test period. A custom made semi-structured interview guide has been conducted asking in more details of experienced quality in use and in managing the mattress. One participant and one nurse will be asked to participate in in-depth interviews after testing both mattresses.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in the pressure injury risk will be assessed via the Braden Scale at study completion at day 14. [ Time Frame: 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.
2. 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. [ Time Frame: 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.

Secondary Outcome Measures :

1. 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. [ Time Frame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study conclusion, 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.
2. 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. [ Time Frame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion 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.
3. 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. [ Time Frame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion 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.
4. 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. [ Time Frame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion 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.
5. 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. [ Time Frame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion 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.
6. 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. [ Time Frame: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Norway

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, Norway, 1450

Sponsors and Collaborators

Sunnaas Rehabilitation Hospital

Investigators

• Principal Investigator: Ingebjørg Irgens, MD; Sunnaas Rehabilitation Hospital

  Study Documents (Full-Text)

Documents provided by Sunnaas Rehabilitation Hospital:

Study Protocol  [PDF] January 1, 2022

Informed Consent Form  [PDF] January 1, 2022

More Information

• Responsible Party: Sunnaas Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT05207891
• Other Study ID Numbers: Mattress Comparison
• First Posted: January 26, 2022
• Last Update Posted: April 14, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data from the pressure measurement and questionnaires will be shared.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Time for sharing is planned to open in 2024, after finishing the study and analysing the data.
• Access Criteria: On request, and in accordance with the Norwegian privacy protecting legislation

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Wounds and Injuries; Crush Injuries