Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 10:24 PM
Study NCT ID:
NCT07470918
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-17
First Post:
2026-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Study Overview
Official Title:
The Effect of Using a Color-Coded Classification System on Pressure Injury Development in the Prevention of Pressure Injury in the Intensive Care Unit
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICU PI Colors
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: