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CompletedNCT07355439PIP-ICUUpdated Feb 9, 2026

Positioning Duration and Pressure Injury Risk

An interventional study of Position Change - 1 Hour and Position Change - 2 Hours in Pressure Injury and Risk Assessment, sponsored by SEMA ŞAHİNER. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by SEMA ŞAHİNER · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jun 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Sex
All
01

Study summary

This research aims to investigate the effect of positioning times on the risk of pressure injury in critically ill patients.

Read the detailed description

Pressure injuries, considered an indicator of quality of care, remain a significant concern today. They are a health problem that reduces the patient's quality of life, complicates the treatment process, and significantly increases costs. Immobility is one of the main risk factors for pressure injury development. In healthy individuals, discomfort occurs in an area subjected to pressure for a long enough period to cause ischemia, and the person changes their position via the afferent sensorimotor feedback system. Fewer than 20 movements per night significantly increase the risk of ulcer development. The factor causing ulcer formation is the inability of the individual to relieve the pressure applied to the tissue. Patients with limited mobility cannot change their body position on their own, and tissue perfusion is impaired in pressure-exposed areas, facilitating ulcer formation. Both the intensity and duration of pressure affect the effect. High pressure causes pressure to build up quickly, while the longer the pressure, the greater the risk of pressure buildup. In individuals at high risk of pressure injuries, frequent position changes are a primary policy for preventing pressure injuries. Experimental studies show that irreversible ischemia occurs when pressure is applied continuously for two hours or longer. The best method for reducing pressure in patients is repositioning. The literature indicates that while pressure injuries cannot be completely prevented, their incidence can be significantly reduced through evidence-based practices, particularly through assessment of at-risk patients, appropriate early nursing interventions, and preventive measures. Advances in the early detection of pressure injuries have been reported in the literature and primarily involve measuring inflammatory markers in anatomical regions to capture the first signs of tissue damage.

02

Conditions studied

  • Pressure Injury
  • Risk Assessment

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Keywords

  • pressure ınjury
  • moisture
  • position duration
  • intensive care unit
  • temperature
03

In context

Pressure Ulcer

517 studies on the registry are indexed under Pressure Ulcer; 116 are open to participants now.

This study's enrollment of 82 is above the median of 70 across 394 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

This is the only study on the registry with SEMA ŞAHİNER as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • - If the patient is conscious, they must volunteer to participate in the study.
  • For unconscious patients, a first-degree relative (mother, father, spouse, child) must agree to participate in the study.
  • The patient's dependency level score on the Barthel Activities of Daily Living Index must be 90 or below (moderately dependent, severely dependent, completely dependent).
  • The patient must not have developed a pressure injury.
  • The patient must be meeting their daily calorie needs as determined by the nutrition team.
  • There must be no contraindications to turning the patient to any side.
  • Patients who are at low risk according to the pressure injury scale (15 points or above according to the Braden Risk Assessment Scale).
  • The patient must not have an acute neurological problem.
  • Patients with a GCS score above 7.

Exclusion criteria

Exclusion Criteria:

  • - If the patient is conscious, they do not consent to participate in the study.
  • For unconscious patients, their first-degree relative does not consent to participate in the study.
  • Patients with a Barthel Activities of Daily Living Index score above 90 (mildly dependent, fully independent).
  • The patient has an existing pressure injury.
  • The patient is not meeting their daily calorie needs as determined by the nutrition team.
  • There is a contraindication to turning the patient to any side.
  • Patients with moderate to high risk according to the pressure injury scale (score below 15 according to the Braden Risk Assessment Scale).
  • The patient has an acute neurological problem.
  • Patients with a GCS score of 7 or below.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    experimental group

    Position changes will be implemented at 1-hour intervals.

    Behavioral: Position Change - 1 Hour

  • Active comparator
    control group

    Position changes will be implemented at 2-hour intervals.

    Behavioral: Position Change - 2 Hours

Interventions

  • BehavioralPosition Change - 1 Hour

    Patient positions will be changed at 1-hour intervals.

  • BehavioralPosition Change - 2 Hours

    Patient positions will be changed at 2-hour intervals.

06

What researchers measure

Primary outcomes

  1. Skin Integrity Changes

    Evaluation of changes in body temperature as a risk factor for pressure injury.

    Time frame: Recording body temperature by measuring it with a body temperature measurement device every 24 hours for 72 hours.

  2. Skin Integrity Changes

    Evaluation of changes in body moisture level as a risk factor for pressure injury

    Time frame: Body moisture will be assessed and documented every 24 hours over a 72-hour period using a body moisture measurement device.

  3. Skin Integrity Changes

    Assessment of the occurrence of changes in skin appearance, such as bruising, considered as risk factors for pressure injury.

    Time frame: Whether changes in skin appearance, such as bruising, occur will be assessed and recorded through observation every 24 hours over a 72-hour period.

  4. Skin Integrity Changes

    Assessment of the occurrence of changes in skin appearance, such as edema, considered as risk factors for pressure injury.

    Time frame: The presence of changes in skin appearance, such as edema, will be assessed and recorded through observation at 24-hour intervals over a 72-hour period.

  5. Skin Integrity Changes

    Assessment of the occurrence of changes in skin appearance, such as redness, considered as risk factors for pressure injury.

    Time frame: The presence of changes in skin appearance, such as redness, will be assessed and recorded through observation at 24-hour intervals over a 72-hour period.

Secondary outcomes

  1. Braden Risk Assessment Score

    Pressure injury risk will be quantitatively assessed using the Braden Pressure Ulcer Risk Assessment Scale, which consists of six subdimensions: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. Total scores range from 6 to 23, with decreasing scores over the assessment period indicating an increased risk of pressure ulcer development.

    Time frame: Evaluations will be conducted and documented at 24-hour intervals over a 72-hour period using the scale.

07

Study locations

1 site
  • Bartin University
    Bartın, 74100, Turkey (Türkiye)
08

References and documents

Publications

  • Esra ÖZKAN, Kemal TURHAN, The Effect of Position Time on the Formation of Pressure Ulcer in Bedridden Patients, Turkiye Klinikleri J Nurs Sci. 2019;11(3):246-54.

Individual participant data

Plan to share: No — In this study, individual patient data was used in an anonymized form and will not be shared with third parties in accordance with the principles of patient privacy and the protection of personal data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07355439
Lead sponsor
SEMA ŞAHİNER
Collaborators
Bartin State Hospital
Responsible party
SEMA ŞAHİNER (graduate student, Bartın Unıversity) — Sponsor-investigator
First posted
Jan 21, 2026
Start date
Jun 1, 2024
Primary completion
Jun 1, 2025
Completion
Jun 30, 2025
Last update
Feb 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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