NCT07355439

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

December 16, 2025

Last Update Submit

February 6, 2026

Conditions

Keywords

pressure ınjurymoistureposition durationintensive care unittemperature

Outcome Measures

Primary Outcomes (5)

  • Skin Integrity Changes

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

    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

    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.

    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.

    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.

    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

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

Study Arms (2)

experimental group

EXPERIMENTAL

Position changes will be implemented at 1-hour intervals.

Behavioral: Position Change - 1 Hour

control group

ACTIVE COMPARATOR

Position changes will be implemented at 2-hour intervals.

Behavioral: Position Change - 2 Hours

Interventions

Patient positions will be changed at 1-hour intervals.

experimental group

Patient positions will be changed at 2-hour intervals.

control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartin University

Bartın, 74100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 82 patients will be divided into 2 groups. One group will have their position changed every hour, and the other group every two hours.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 21, 2026

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations