Pressure InjuryNCT05207891
Comparing Pressure Injury Occurrence in Patients Using Two Different Mattresses
A study testing Intervention mattress in people with Pressure Injury and Sleep, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Sleep, Pain
- What is being tested?
- Intervention mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 14 Sep 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- Ongoing pressure injury
- External fixation, except neck collar
- Body weight > 150 kg
- pre-test pressure assessment above the maximum pressure limit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Two Types of Dynamic Air Mattresses, With Focus on Changes in Pressure Injury Occurrence and Functionality
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 .
Read the 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.
- Conditions
- Pressure Injury, Sleep, Pain, Satisfaction, Patient, Noise Exposure, Strains
- Being tested
- Intervention mattress
- Medical subject headings
- Pressure Ulcer, Pain, Patient Satisfaction, Sprains and Strains, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention mattressDevice
Also called Tidewave
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention mattress | Experimental | 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. Receives: Device: Intervention mattress |
| Regulare care mattress | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pressure injury risk assessment will be performed at baseline (day zero) and at study completion at day 14.
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.
Measured: Pressure injury occurence will be assessed from baseline (day zero) and once a day to study completion at day 14.
Secondary outcomes (6)
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.
Measured: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study conclusion, 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.
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.
Measured: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
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.
Measured: 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.
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.
Measured: 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 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.
Measured: 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.
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.
Measured: Assessment will be performed at baseline (day zero), at change of mattress at day seven, and at study completion at day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start14 Sep 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingebjørg Irgens, MD, Principal investigator, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207891
- Sponsor's protocol ID
- Mattress Comparison
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the pressure measurement and questionnaires will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Types of Dynamic Air Mattresses, With Focus on Changes in Pressure Injury Occurrence and Functionality
- ClinicalTrials.gov ID
- NCT05207891
- Acronym / sponsor ID
- Mattress Comparison
- Conditions
- Pressure Injury, Sleep, Pain, Satisfaction, Patient, Noise Exposure, Strains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention mattress | Experimental | Device: Intervention mattressAt 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. |
| Regulare care mattress | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 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
Key exclusion criteria (4 listed)
- Ongoing pressure injury
- External fixation, except neck collar
- Body weight > 150 kg
- pre-test pressure assessment above the maximum pressure limit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention mattressAlso: TidewaveThe 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. | Device | Intervention mattress |
Primary outcome
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Yes. Data from the pressure measurement and questionnaires will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingebjørg Irgens, MD principal investigator
Sunnaas Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention mattress in people with Pressure Injury and Sleep, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.