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

NCT06977152 | Recruiting

• 1 other identifier: 2025.114.IRB2.059
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pressure Injury Development

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

  0-14 days after the beginning of mechanical ventilation support

Secondary Outcomes (1)

• Pressure Measurement

  1st day, 7th day and 14th day of use of support surfaces.

Study Arms (2)

Fluidized positioner

EXPERIMENTAL

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.

Device: Fluidized Positioner

Memory foam pillow

ACTIVE COMPARATOR

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.

Device: Memory foam pillow

Interventions

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.

Memory foam pillow

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.

Fluidized positioner

Eligibility Criteria

• Age: 28 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Koç University Hospital: collaborator
• Koç University: lead

Study Sites (1)

Koç University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Enes Şimşek, MSc. PhD(c)

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enes Şimşek, MSc. PhD(c)

CONTACT

+90 546 250 2050; enessimsek19@ku.edu.tr

Remziye Semerci, PhD.

CONTACT

+90 535 011 28 21

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 18, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)