Actively Recruiting
Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in Children's Heads A Randomised Controlled Study
Led by Koç University · Updated on 2026-03-31
32
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
K
Koç University
Lead Sponsor
K
Koc University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two types of head and neck support devices—the fluidized positioner and the memory foam pillow—to see which is more effective at preventing pressure injuries in young children in the pediatric intensive care unit (PICU). The study specifically focuses on children aged 28 days to 5 years who require mechanical ventilation and are immobile. The goal is to understand differences in pressure injury rates, pressure distribution, and injury locations on the head using these two devices. Children in the study will be randomly assigned to receive either a fluidized positioner or a memory foam pillow placed under their head and neck immediately after starting mechanical ventilation support in the PICU. The study is designed as a randomized controlled trial with double blinding to compare these two devices. Both groups will be monitored over a period of up to 14 days while using their assigned support surface. Throughout the study, researchers will monitor the development of pressure injuries on the head from the start of mechanical ventilation up to 14 days. Pressure measurements on the first, seventh, and fourteenth days of device use will also be recorded to assess pressure distribution. Participants will be closely observed to collect sufficient data, and any new health conditions affecting pressure injury risk will be noted. The total participation duration for each child is up to 14 days.
CONDITIONS
Brief Title
Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Being treated in the pediatric intensive care unit
- Receiving mechanical ventilation
- Being immobile
- Age between 28 days and 5 years
- Having consent for participation in the study
You will not qualify if you...
- Having surgical intervention in the head region
- Parents wanting to leave at any stage of the project
- Having hydrocephalus or burns on the head
- Having pressure injuries on admission to hospital
- Existing dermatologic diseases affecting the skin or connective tissue
- Development of a new condition during the intervention that significantly affects pressure injury risk
- Inability to obtain sufficient data during the study (e.g., patient transfer)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days during mechanical ventilation support
Participants receive either a fluidized positioner or a memory foam pillow placed under their head and neck immediately after starting mechanical ventilation support in the pediatric intensive care unit.
Visits on Day 1, Day 7, and Day 14 for pressure measurements
Trial Site Locations
Total: 1 location
1
Koç University Hospital
Istanbul, Zeytinburnu, Turkey (Türkiye), 34010
Actively Recruiting
Research Team
E
Enes Şimşek, MSc. PhD(c)
R
Remziye Semerci, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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