- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06908512
Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)
March 26, 2025 updated by: İbrahim Caner Di̇ki̇ci̇, Harran University
Turkish Adaptation, Validity and Reliability of the Intensive Care Unit-specific Pressure Injury Risk Assessment Scale
The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale
Study Overview
Status
Not yet recruiting
Detailed Description
This was a prospective, cross-sectional study aimed at translation and cultural adaptation of the RAPS-ICU into Turkish, while also assessing its validity and reliability.Patients who meet the inclusion criteria and who are hospitalized in the Intensive Care Clinics of Istinye University Bahçeşehir Liv Hospital and Harran University Hospital will participate in the study.
In this study, Turkish adaptation of the 'Intensive care unit-specific pressure injury risk assessment scale' is planned.
After language adaptation, its validity and reliability will be tested.
The reliability of the intensive care unit-specific pressure injury risk assessment scale will be assessed by inter-rater reliability and internal consistency (determined by calculating Cronbach alpha coefficient), and its validity will be assessed by convergent and divergent validity of the scale.
Relative reliability was obtained by calculating the intraclass correlation coefficient (ICC).
Relative reliability will be obtained by calculating the intraclass correlation coefficient (ICC).
The receiver operator characteristics (ROC) curve has been used to estimate sensitivity and specificity and will represent the false positive rate versus the true positive rate across various thresholds for different scores.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ibrahim C Dikici, Assist. Prof.
- Phone Number: +905376729057
- Email: ibrahimcanerdikici@gmail.com
Study Contact Backup
- Name: Yunus E Tütüneken, Research Assistant
- Phone Number: +905435912455
- Email: yunus.tutuneken@istinye.edu.tr
Study Locations
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Sanliurfa, Turkey, 63000
- Harran University
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients in intensive care units
Description
Inclusion Criteria:
- 18 years of age or older,
- Staying in the Intensive Care Unit for at least 1 day,
- Agreeing to participate in the study by themselves or a family member.
- Volunteering to participate in the research
- Full orientation and no psychiatric problems
Exclusion Criteria:
- Having communication problems
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU-Specific Pressure Injury Risk Assessment Scale (RAPS-ICU)
Time Frame: Baseline
|
The RAPS-ICU was developed by W°ahlin et al to identify patients at risk of developing pressure injuries in the ICU.
The RAPS-ICU has six domains that assess failure in vital organs, mobility, moisture, sensory perceptions, special treatments, and consciousness.
Five of the six domains scored 1-4 points progressing from most to least severity of alteration; failure in vital organs domains ranged from 1-3 points.
Overall PI risk is reflected by a total score ranging from 6 to 23.
The lower the total score the greater the estimated risk of developing a PI.
Risk scores can be categorized as increased (16-18), high (12-15), and very high (≤11) risk for PI.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ayşe Şahin, Assist. Prof., Harran University
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.
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 (Estimated)
March 30, 2025
Primary Completion (Estimated)
July 12, 2025
Study Completion (Estimated)
November 12, 2025
Study Registration Dates
First Submitted
March 19, 2025
First Submitted That Met QC Criteria
March 26, 2025
First Posted (Actual)
April 3, 2025
Study Record Updates
Last Update Posted (Actual)
April 3, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NT268347145
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
product manufactured in and exported from the U.S.
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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