Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention … (NCT06977152) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head
Turkey (Türkiye)32 participantsStarted 2025-06-01
Plain-language summary
This study aims to compare the effectiveness of fluidized positioners and memory foam pillows in preventing pressure injuries in the head among pediatric patients.
H1: There is a significant difference between the fluidized positioner and the memory foam pillow in terms of pressure injury incidence in pediatric intensive care patients.
H2: The fluidized positioner reduces the risk of developing pressure injuries more effectively than the memory foam pillow.
H3: There is a significant difference in the pressure applied to the head region of the patient between the fluidized positioner and the memory foam pillow.
H4: The anatomical locations of pressure injuries (occipital, parietal, temporal, and ear regions) vary depending on the type of pillow used.
H5: Compared to the memory foam pillow, the fluidized positioner is associated with a more homogeneous pressure distribution across the occipital, parietal, and temporal regions.
Who can participate
Age range
28 Days – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Being treated in the pediatric intensive care unit
* Being mechanically ventilated
* Being immobile, being in age interval of 28 days to 5 years
* Having consent for the participation of the study
Exclusion Criteria:
* Having surgical intervention in the head region
* Parents want to leave at any stage of the project
* Having hydrocephalus or burn in the head area
* Having PIs on admission to hospital
* Existing dermatologic diseases affecting the skin or connective tissue
* Having emergence of a new condition during the intervention may significantly affect the risk of pressure injury (e.g., sudden surgery or complication)
* Inability to obtain sufficient data during the study (e.g., patient transfer)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared a fluidized positioner versus a memory foam pillow to prevent pressure injuries on children's heads — based on the results, does my child's care team have a preference for one over the other given my child's specific situation?
2Since this trial has already been completed, have the findings been published or shared anywhere, and could you help me understand what the results showed about which pillow type was more effective at preventing head pressure injuries in children?
3Pressure injuries on a child's head can develop during prolonged stays or immobility — how does my child's level of mobility or time spent in one position factor into which positioning device their care team would recommend?
4Are there other factors beyond pillow type — like repositioning schedules or skin monitoring routines — that this trial may not have addressed but that are equally important for reducing my child's risk of a head pressure injury?
5If my child's hospital or clinic hasn't yet adopted findings from trials like this one, what is the current standard approach being used to protect my child's head from pressure injuries, and is there a reason to consider something different?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pressure Injury Development
Timeframe: 0-14 days after the beginning of mechanical ventilation support