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Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head

Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head: A Randomised Controlled Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06977152
Enrollment
32
Registered
2025-05-18
Start date
2025-06-01
Completion date
2026-06-14
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Injury

Keywords

pediatric patients, Pressure injury, Risk assessment, foam pillow, fluidized positioner

Brief 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.

Interventions

DEVICEMemory foam pillow

Patients in the memory foam pillow intervention group will have a memory foam pillow placed under their head and neck immediately after the initiation of mechanical ventilation support in the PICU.

DEVICEFluidized Positioner

Patients in the fluidized positioner intervention group will have a fluidized positioner placed under their head and neck immediately after the initiation of mechanical ventilation support in the PICU.

Sponsors

Koç University
Lead SponsorOTHER
Koc University Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Days to 5 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pressure Injury Development0-14 days after the beginning of mechanical ventilation supportThe study will compare the incidence, stage, and anatomical location of PIs between the two groups.

Secondary

MeasureTime frameDescription
Pressure Measurement1st day, 7th day and 14th day of use of support surfaces.Regional pressure distribution across the occipital, parietal, temporal, and auricular areas, used to characterize pressure redistribution performance of the support surface.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOREnes Şimşek, MSc. PhD(c)

Koç University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026