The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit (ICU PI Colors)

March 13, 2026 updated by: Ece Nur Aykenar, Saglik Bilimleri Universitesi

The Effect of Using a Color-Coded Classification System on Pressure Injury Development in the Prevention of Pressure Injury in the Intensive Care Unit

This study is designed as a randomized controlled trial to examine the effect of using a color-coded classification system that identifies the risks of pressure injuries in the intensive care unit on the development of pressure injuries.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Pressure injuries, generally defined as localized injuries resulting from pressure or friction accompanied by pressure and/or tearing/rupture in the skin and/or deep tissues over bony prominences, are one of the most significant health problems in healthcare services worldwide, both for individuals and institutions. In pressure injuries, the primary roles of nurses are to assess individuals at risk using valid and reliable risk assessment tools, take measures to eliminate causative factors, protect and maintain skin integrity, and prevent the development of pressure injuries; and, when a pressure injury develops, to provide nursing care in collaboration with the individual and their family, taking into account individual characteristics, to promote healing and prevent recurrence.

Since pressure injuries are largely preventable, identifying individuals at the highest risk and providing timely preventive care is crucial. Many valid and reliable risk assessment tools have been developed to identify individuals in the high-risk group. However, there is much debate in the literature regarding the benefits of pressure injury risk assessment tools. One of these debates is that the tools used by nurses to assess the risk of pressure injuries require a great deal of time, energy, and effort. Furthermore, the literature suggests that these tools should be presented in a user-friendly format to encourage clinicians to use them. A study by Creehan and Brindle found that nurses frequently record a risk score for pressure injuries in their records but often fail to implement interventions.

A review of the literature reveals that the lack of user-friendly formats in risk assessment tools used in intensive care units to prevent pressure injuries, inconsistencies in interpreting the separate categories causing pressure injuries, and the insufficient reflection of risk scores obtained in risk assessments in nursing care are identified as obstacles to preventing pressure injuries. Moreover, the number of applications developed to address these problems is quite limited in the literature.

The study will be conducted as a prospective randomized controlled trial. After obtaining verbal and written consent from individuals before and after clinical intervention, the study will be conducted using various data collection forms.

These forms are: Braden Pressure Injury Risk Assessment Scale, Color-Coded Braden Pressure Injury Risk Assessment Scale, Participant Identification Form, Skin Assessment Form, Pressure Injury Incidence Monitoring Form, and Position Monitoring-Control Form. Participants will be randomized.

Color-Coded Braden Pressure Injury Risk Assessment Scale group in group-I (n=48), and group II (n=48) will be the control group.

In the first stage; pressure injury risk score for individuals in Group I (n=48) will be determined using the Color-Coded Braden Pressure Injury Risk Assessment Scale, and the pressure injury risk score for individuals in Group II (n=48) will be determined using the Braden Pressure Injury Risk Assessment Scale. The defining characteristics of individuals in Group-I and Group-II, whose risk scores have been determined, will be recorded on the Participant Identification Form.

Color-coded pressure injury risk levels for individuals in Group I will be displayed at the bedside of the patient using color-coded cards: red indicates high risk, yellow indicates medium risk, and green indicates low risk. This application aims to enable nurses to quickly and visually identify pressure injury risks in patients. The skin condition of individuals identified by color codes will be observed and recorded on the Skin Assessment Form. The development of possible pressure injuries will be monitored using the Pressure Injury Incidence Monitoring Form, and the frequency of position changes will be monitored using the Position Monitoring-Control Form.

Individuals in Group II, whose risk level for pressure injuries is determined using the Braden Pressure Injury Risk Assessment Scale, will have their skin condition observed and recorded on the Skin Assessment Form. Pressure injuries will be monitored using the Pressure Injury Incidence Monitoring Form, and the regularity of position changes will be monitored using the Position Monitoring-Control Form.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • University of Health Sciences Turkiye Gulhane Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Agreeing to participate in the study
  • Participants who do not have a pre-existing pressure injury upon hospital admission

Exclusion Criteria:

  • Wanting to withdraw from the study
  • Discharge from hospital or change of department before completing the number of days determined during the data collection phase

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Color-Coded Pressure Injury Risk Assessment Group

Participants' pressure injury risk will be assessed with the Color-Coded Braden Pressure Injury Risk Assessment Scale.

Participants will be evaluated every 24 hours from the beginning of the 0th measurement time to the end of the 5th measurement time. Pressure injury status (present/absent), occurrence time, stage, location, and cause will be recorded.
Other: Color-Coded Pressure Injury Risk Assessment Group
Color-coded pressure injury risk levels will be displayed at the bedside of the patient using color-coded cards: red indicates high risk, yellow indicates medium risk, and green indicates low risk. Participants will be evaluated every 24 hours from the beginning of the 0th measurement time to the end of the 5th measurement time. Pressure injury status (present/absent), occurrence time, stage, location, and cause will be recorded.
No Intervention: No Intervention: Control Group

Participants' pressure injury risk will be assessed with the Braden Risk Assessment Scale.

Participants will be evaluated every 24 hours from the beginning of the 0th measurement time to the end of the 5th measurement time. Pressure injury status (present/absent), occurrence time, stage, location, and cause will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital-Acquired Pressure Injury Incidence
Time Frame: During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.
The Color-Coded Braden Pressure Injury Risk Assessment Scale will be used to assess the risk of pressure injury in participants. This scale, which presents risk levels using a color-coded system, is expected to facilitate rapid risk identification and support timely preventive nursing interventions. The impact of this approach on pressure injury development and patient outcomes will be evaluated. This status will be evaluated with the Pressure Injury Frequency Monitoring Form, developed based on the European Pressure Ulcer Advisory Panel / National Pressure Injury Advisory Panel (2019) pressure injury staging system. All participants hospitalized in the unit will be assessed every 24 hours from the first day of their hospital admission until the 5th day. The presence or absence of pressure ulcers, time of onset, stage, anatomical location, and cause will be recorded.
During the hospital stay, assessments are conducted every 24 hours from day 1 to day 5 of hospital admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12121212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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