Pressure InjuryPIP-ICUNCT07355439
Positioning Duration and Pressure Injury Risk
A study testing Position Change - 1 Hour and Position Change - 2 Hours in people with Pressure Injury and Risk Assessment, run by SEMA ŞAHİNER at 1 site in Turkey (Türkiye).
Trial summary
This research aims to investigate the effect of positioning times on the risk of pressure injury in critically ill patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Risk Assessment
- What is being tested?
- Position Change - 1 Hour and Position Change - 2 Hours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 30 Jun 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- - 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.
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- 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.
Who cannot join
- - 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Positioning Duration on Pressure Injury Risk in Intensive Care Patients
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.
- Conditions
- Pressure Injury, Risk Assessment
- Being tested
- Position Change - 1 Hour, Position Change - 2 Hours
- Keywords
- pressure ınjury, moisture, position duration, intensive care unit, temperature
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position Change - 1 HourBehavioural
Patient positions will be changed at 1-hour intervals.
Position Change - 2 HoursBehavioural
Patient positions will be changed at 2-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Position changes will be implemented at 1-hour intervals. Receives: Behavioral: Position Change - 1 Hour |
| control group | Active comparator | Position changes will be implemented at 2-hour intervals. Receives: Behavioral: Position Change - 2 Hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Integrity Changes
Evaluation of changes in body temperature as a risk factor for pressure injury.
Measured: Recording body temperature by measuring it with a body temperature measurement device every 24 hours for 72 hours.
Skin Integrity Changes
Evaluation of changes in body moisture level as a risk factor for pressure injury
Measured: Body moisture will be assessed and documented every 24 hours over a 72-hour period using a body moisture measurement device.
Skin Integrity Changes
Assessment of the occurrence of changes in skin appearance, such as bruising, considered as risk factors for pressure injury.
Measured: Whether changes in skin appearance, such as bruising, occur will be assessed and recorded through observation every 24 hours over a 72-hour period.
Skin Integrity Changes
Assessment of the occurrence of changes in skin appearance, such as edema, considered as risk factors for pressure injury.
Measured: 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.
Skin Integrity Changes
Assessment of the occurrence of changes in skin appearance, such as redness, considered as risk factors for pressure injury.
Measured: 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.
Measured: Evaluations will be conducted and documented at 24-hour intervals over a 72-hour period using the scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 82 patients will be divided into 2 groups. One group will have their position changed every hour, and the other group every two hours.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEMA ŞAHİNER
- Sponsor type
- University, hospital or other
- Collaborators
- Bartin State Hospital
- Responsible party
- Sponsor-investigator, SEMA ŞAHİNER, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355439
- Sponsor's protocol ID
- 2024-SBB-0140
- Acronym
- PIP-ICU
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positioning Duration on Pressure Injury Risk in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT07355439
- Acronym / sponsor ID
- PIP-ICU / 2024-SBB-0140
- Conditions
- Pressure Injury, Risk Assessment
- Keywords
- pressure ınjury, moisture, position duration, intensive care unit, temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- SEMA ŞAHİNERUniversity, hospital or other
- Collaborators
- Bartin State Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Jan 2026 (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 research aims to investigate the effect of positioning times on the risk of pressure injury in critically ill patients.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 82 patients will be divided into 2 groups. One group will have their position changed every hour, and the other group every two hours.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Position Change - 1 HourPosition changes will be implemented at 1-hour intervals. |
| control group | Active comparator | Behavioral: Position Change - 2 HoursPosition changes will be implemented at 2-hour intervals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- - 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.
Key exclusion criteria (9 listed)
- - 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.
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 |
|---|---|---|
| Position Change - 1 HourPatient positions will be changed at 1-hour intervals. | Behavioural | experimental group |
| Position Change - 2 HoursPatient positions will be changed at 2-hour intervals. | Behavioural | control group |
Primary outcome
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.
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
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.
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.
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.
1 secondary outcome
Braden Risk Assessment Score
Time frame: Evaluations will be conducted and documented at 24-hour intervals over a 72-hour period using the scale.
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 9 Feb 2026.
- BackgroundEsra 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.
- NATIONAL PRESSURE ULCER ADVISORY PANELLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position Change - 1 Hour and Position Change - 2 Hours in people with Pressure Injury and Risk Assessment, run by SEMA ŞAHİNER 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 9 inclusion and 9 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 9 Feb 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?
Skin Integrity Changes (time frame: Recording body temperature by measuring it with a body temperature measurement device every 24 hours for 72 hours.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07355439, which also lists 1 linked publication.
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 9 Feb 2026.