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Comparing Pressure Injury Occurrence in Patients Using Two Different Mattresses

NCT05207891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-04-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sunnaas Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Ingebjørg Irgens, MD · Sunnaas Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207891 on ClinicalTrials.gov