Comparing Pressure Injury Occurrence in Patients Using Two Different Mattresses

NCT05207891 | Completed DMC

• 1 other identifier: Mattress Comparison
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 .

Conditions

Pressure Injury; Sleep; Pain; Satisfaction, Patient; Noise Exposure; Strains; Satisfaction, Personal

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 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.

  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.

  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.

  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.

• 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.

Study Arms (2)

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.

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.

Interventions

Intervention mattress DEVICE

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.

Also known as: Tidewave

Intervention mattress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, Akershus, 1450, Norway

Location

MeSH Terms

Conditions

Pressure Ulcer; Pain; Patient Satisfaction; Sprains and Strains; Personal Satisfaction

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Wounds and Injuries

Study Officials

• Ingebjørg Irgens, MD

  Sunnaas Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: January 26, 2022
• Study Start: September 14, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

NO (1)