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

Koç University

Status: Begins enrollment this month

Conditions: Pressure Injury

Treatments: Device: Fluidized Positioner; Device: Memory foam pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT06977152

2025.114.IRB2.059

Details and patient eligibility

About

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 provides a more evenly distributed pressure across the occipital, parietal, temporal, and ear regions and prevents pressure concentration in specific areas.

Enrollment: 64 estimated patients

Sex: All

Ages: 28 days to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Fluidized positioner

Experimental group

Description:

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

Treatment:

Device: Fluidized Positioner

Memory foam pillow

Active Comparator group

Description:

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

Treatment:

Device: Memory foam pillow