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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pressure Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fluidized positioner

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.

Group Type EXPERIMENTAL

Fluidized Positioner

Intervention Type 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.

Memory foam pillow

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.

Group Type ACTIVE_COMPARATOR

Memory foam pillow

Intervention Type 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.

Interventions

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Memory 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.

Intervention Type DEVICE

Fluidized 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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

28 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No