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Completed

NCT Number: NCT06977152

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

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.

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Key information

Conditions

Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

28 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Memory foam pillow

Device

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.

Fluidized Positioner

Device

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.

Primary outcomes

  1. Pressure Injury Development

    Time frame: 0-14 days after the beginning of mechanical ventilation support

    The study will compare the incidence, stage, and anatomical location of PIs between the two groups.

Secondary outcomes

  1. Pressure Measurement

    Time frame: 1st 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.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Collaborators

  • Koc University Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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