Pressure InjuryNCT06977152
Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head
A study testing Memory foam pillow and Fluidized Positioner in people with Pressure Injury, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 28 days to 5 years
- Conditions the study is for
- Pressure Injury
- What is being tested?
- Memory foam pillow and Fluidized Positioner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 14 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University Hospital
Istanbul, Zeytinburnu, 34010
About this study
Official 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
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.
Read more
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
- Being tested
- Memory foam pillow, Fluidized Positioner
- Keywords
- pediatric patients, Pressure injury, Risk assessment, foam pillow, fluidized positioner
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory foam pillowDevice
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 PositionerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Memory foam pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Injury Development
The study will compare the incidence, stage, and anatomical location of PIs between the two groups.
Measured: 0-14 days after the beginning of mechanical ventilation support
Secondary outcomes (1)
Pressure Measurement
Regional pressure distribution across the occipital, parietal, temporal, and auricular areas, used to characterize pressure redistribution performance of the support surface.
Measured: 1st day, 7th day and 14th day of use of support surfaces.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Koc University Hospital
- Responsible party
- Principal investigator, Enes Simsek, Koç University
- Investigators
- Enes Şimşek, MSc. PhD(c), Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977152
- Sponsor's protocol ID
- 2025.114.IRB2.059
- Status last verified
- May 2025
- First submitted
- 26 Apr 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06977152
- Acronym / sponsor ID
- 2025.114.IRB2.059
- Conditions
- Pressure Injury
- Keywords
- pediatric patients, Pressure injury, Risk assessment, foam pillow, fluidized positioner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Koc University Hospital
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluidized positioner | Experimental | Device: Fluidized PositionerPatients 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. |
| Memory foam pillow | Active comparator | Device: Memory foam pillowPatients 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. |
Who may qualify
- Ages
- 28 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory foam pillowPatients 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. | Device | Memory foam pillow |
| Fluidized PositionerPatients 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. | Device | Fluidized positioner |
Primary outcome
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.
1 secondary outcome
Pressure Measurement
Time frame: 1st day, 7th day and 14th day of use of support surfaces.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enes Şimşek, MSc. PhD(c) principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory foam pillow and Fluidized Positioner in people with Pressure Injury, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Injury Development (time frame: 0-14 days after the beginning of mechanical ventilation support). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.