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Completed

NCT Number: NCT07355439

Positioning Duration and Pressure Injury Risk

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bartin University

Bartın, 74100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • - 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.

Treatment and study plan

Position Change - 1 Hour

Behavioral

Patient positions will be changed at 1-hour intervals.

Position Change - 2 Hours

Behavioral

Patient positions will be changed at 2-hour intervals.

Primary outcomes

  1. Skin Integrity Changes

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

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

  2. Skin Integrity Changes

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

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

  3. Skin Integrity Changes

    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.

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

  4. Skin Integrity Changes

    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.

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

  5. Skin Integrity Changes

    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.

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

Secondary outcomes

  1. Braden Risk Assessment Score

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

    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.

Sponsors and collaborators

Lead sponsor

SEMA ŞAHİNER

Other

Collaborators

  • Bartin State Hospital

Registry information

Official study title

The Effect of Positioning Duration on Pressure Injury Risk in Intensive Care Patients

Acronym: PIP-ICU

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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