Pressure InjuryNCT06908512
Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)
An observational study of Pressure Injury and Reliability and Validity, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Reliability and Validity, Intensive Care Units (ICUs)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 12 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients in intensive care units
Who may be able to join
- 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
Who cannot join
- Having communication problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Keywords
- Pressure Injury, Reliability and Validity, Intensive Care Units, Assessment Scale
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-Specific Pressure Injury Risk Assessment Scale (RAPS-ICU)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start30 Mar 2025 (estimated)
- Primary completion12 Jul 2025 (estimated)
- Study completion12 Nov 2025 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Caner Di̇ki̇ci̇, Harran University
- Investigators
- Ayşe Şahin, Assist. Prof., Study chair, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908512
- Sponsor's protocol ID
- NT268347145
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wahlin I, Ek AC, Lindgren M, Geijer S, Arestedt K. Development and validation of an ICU-specific pressure injury risk assessment scale. Scand J Caring Sci. 2021 Sep;35(3):769-778. doi: 10.1111/scs.12891. Epub 2020 Jul 14.
PubMed 32666602
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability of the Intensive Care Unit-specific Pressure Injury Risk Assessment Scale
- ClinicalTrials.gov ID
- NCT06908512
- Acronym / sponsor ID
- NT268347145
- Keywords
- Pressure Injury, Reliability and Validity, Intensive Care Units, Assessment Scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 12 Jul 2025 (estimated)
- Study completion
- 12 Nov 2025 (estimated)
- First posted
- 3 Apr 2025 (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.
The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in intensive care units
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Having communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 32666602Wahlin I, Ek AC, Lindgren M, Geijer S, Arestedt K. Development and validation of an ICU-specific pressure injury risk assessment scale. Scand J Caring Sci. 2021 Sep;35(3):769-778. doi: 10.1111/scs.12891. Epub 2020 Jul 14.
- Individual participant dataSharing planned: No
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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.
Ayşe Şahin, Assist. Prof. study chair
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury and Reliability and Validity, run by Harran University 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim C Dikici, Assist. Prof. (+905376729057, ibrahimcanerdikici@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU-Specific Pressure Injury Risk Assessment Scale (RAPS-ICU) (time frame: Baseline). 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 NCT06908512, 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 3 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.