Pressure InjuriesNCT07454746
Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale
An observational study of Pressure Injuries and Intensive Care (ICU), run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to translate and culturally adapt the Critical Care Pressure Ulcer Assessment Tool Made Easy (CALCULATE) into Turkish and to evaluate its validity and reliability for use in ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injuries, Intensive Care (ICU)
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 30 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants were recruited from the Anesthesiology and Reanimation Intensive Care Unit of a training and research hospital in Istanbul, Türkiye. Participants were enrolled from patients receiving routine care in this ICU.
Who may be able to join
- participants were adults (≥ 18 years)
- ICU length of stay of ≥24 h
- No Pressure ınjury at admission
Who cannot join
- Patients discharged before completing 24 hours in the ICU
- Patients who were not cared for on specialized beds used in the ICU
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Mehmet Ali Aydınlar University Department of Nursing, Faculty of Health Sciences
Istanbul, Ataşehir, 34758
About this study
Official title: Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale in Intensive Care Unit Patients
This study aimed to translate and culturally adapt the Critical Care Pressure Ulcer Assessment Tool Made Easy (CALCULATE) into Turkish and to evaluate its validity and reliability for use in ICU patients.
This study sought to answer the following questions:
Is the Turkish version of the CALCULATE Pressure Injury Risk Assessment Scale a valid instrument for determining the risk of pressure injury in patients hospitalized in the Intensive Care Unit (ICU)?
Is the Turkish version of the CALCULATE Pressure Injury Risk Assessment Scale a reliable instrument for determining the risk of pressure injury in patients hospitalized in the Intensive Care Unit (ICU)?
Read the detailed description
Pressure injuries (PIs) are largely preventable adverse events that reduce patients' quality of life and create a substantial financial burden on healthcare systems. A PI is a localized injury to the skin and/or underlying tissue, usually over a bony prominence or related to a medical device, caused by pressure and/or shear forces.
Patients in intensive care units (ICUs) are among the most vulnerable groups because they are exposed to multiple risk factors, including immobility, sedation, mechanical ventilation, hemodynamic instability, and medical devices. As a result, the risk of developing PIs in the ICU is reported to be about four times higher than in other patient groups, and most cases occur between 5 and 25 days of hospitalization.
International evidence shows that PI prevalence and incidence are higher in ICUs than in general wards. PIs, especially advanced-stage injuries, are also associated with significantly increased treatment costs. In Türkiye, although rates vary across institutions, PI occurrence in ICUs remains clinically significant, and medical device-related pressure injuries (MDRPIs) constitute a considerable proportion of cases.
Preventing hospital-acquired PIs is widely accepted as an important indicator of healthcare quality and remains a major clinical priority. The 2025 EPUAP guideline emphasizes that risk assessment should be considered not only as a screening step but as a comprehensive clinical decision-making process that guides individualized preventive care plans. Although more than 40 instruments have been developed to assess PI risk, tools designed for general patient populations may not adequately reflect the unique risk profile of critically ill ICU patients.
Based on this rationale, a validity and reliability study of the CALCULATE Pressure Injury Risk Assessment Scale, which was developed in the United Kingdom, was conducted in Türkiye.
- Conditions
- Pressure Injuries, Intensive Care (ICU)
- Being tested
- ICU pressure injury prevention protocol as standard care
- Keywords
- pressure injury, intensive care, risk assessment, CALCULATE, validity, reliability, ROC, inter-rater reliability
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU pressure injury prevention protocol as standard careOther
Patients were followed from the time of ICU admission until discharge. During the follow-up period, pressure injury risk was assessed only through the CALCULATE and Braden scales; no additional intervention was applied as part of the study. Throughout hospitalization, all patients received the unit's routine ICU pressure injury prevention protocol as standard care.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients | Population consisted of patients admitted to a Level III Anesthesiology and Reanimation ICU Receives: Other: ICU pressure injury prevention protocol as standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the CALCULATE Pressure Injury Risk Assessment Scale
Validity of the CALCULATE Pressure Injury Risk Assessment Scale for assessing pressure injury risk in ICU patients, evaluated using daily risk assessments during ICU stay and comparison with the Braden Scale. The Braden Scale used in clinical settings and generates a total score ranging from 6 to 23, with lower scores indicating a higher risk of PI development. According to the CALCULATE for Pressure Injury risk assessment total score, patients with ≥4 risk factors are categorized as "very high risk," whereas those with ≤3 risk factors are classified as "high risk"
Measured: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.
Reliability of the CALCULATE Pressure Injury Risk Assessment Scale
Reliability of the CALCULATE Pressure Injury Risk Assessment Scale for assessing pressure injury risk in ICU patients, evaluated using daily risk assessments during ICU stay and comparison with the Braden Scale. The Braden Scale used in clinical settings and generates a total score ranging from 6 to 23, with lower scores indicating a higher risk of PI development. According to the CALCULATE for Pressure Injury risk assessment total score, patients with ≥4 risk factors are categorized as "very high risk," whereas those with ≤3 risk factors are classified as "high risk" .
Measured: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Oct 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- 76 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ukke Karabacak, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454746
- Sponsor's protocol ID
- 2023-15/520
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baykara ZG, Karadag A, Bulut H, Duluklu B, Karabulut H, Aktas D, Celik SS, Guler S, Ay A, Gul S, Ozturk D, Irmak B, Aydogan S, Cebeci F, Karakaya D, Avsar P. Pressure Injury Prevalence and Risk Factors: A National Multicenter Analytical Study. J Wound Ostomy Continence Nurs. 2023 Jul-Aug 01;50(4):289-295. doi: 10.1097/WON.0000000000000995.
PubMed 37467407Hyun JE, Park SK. Characteristics of and Risk Factors for Medical Device-Related Pressure Injuries in Trauma Patients in Intensive Care Units: A Retrospective Case-Control Study. West J Nurs Res. 2026 Feb;48(2):131-141. doi: 10.1177/01939459251389331. Epub 2025 Dec 3.
PubMed 41332352Richardson A, Barrow I. Part 1: Pressure ulcer assessment - the development of Critical Care Pressure Ulcer Assessment Tool made Easy (CALCULATE). Nurs Crit Care. 2015 Nov;20(6):308-14. doi: 10.1111/nicc.12173. Epub 2015 Mar 19.
PubMed 25787920Richardson A, Straughan C. Part 2: pressure ulcer assessment: implementation and revision of CALCULATE. Nurs Crit Care. 2015 Nov;20(6):315-21. doi: 10.1111/nicc.12172. Epub 2015 Mar 19.
PubMed 25787803Alkan AO, Karabacak U. Turkish Translation and Cultural Adaptation, Validity and Reliability of the CALCULATE Pressure Injury Risk Scale in Intensive Care Unit Patients. Nurs Open. 2026 Sep;13(9):e70742. doi: 10.1002/nop2.70742.
PubMed 42746693
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07454746
- Acronym / sponsor ID
- 2023-15/520
- Conditions
- Pressure Injuries, Intensive Care (ICU)
- Keywords
- pressure injury, intensive care, risk assessment, CALCULATE, validity, reliability, ROC, inter-rater reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 6 Mar 2026 (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.
This study aimed to translate and culturally adapt the Critical Care Pressure Ulcer Assessment Tool Made Easy (CALCULATE) into Turkish and to evaluate its validity and reliability for use in ICU patients.
This study sought to answer the following questions:
Is the Turkish version of the CALCULATE Pressure Injury Risk Assessment Scale a valid instrument for determining the risk of pressure injury in patients hospitalized in the Intensive Care Unit (ICU)?
Is the Turkish version of the CALCULATE Pressure Injury Risk Assessment Scale a reliable instrument for determining the risk of pressure injury in patients hospitalized in the Intensive Care Unit (ICU)?
Detailed description
Pressure injuries (PIs) are largely preventable adverse events that reduce patients' quality of life and create a substantial financial burden on healthcare systems. A PI is a localized injury to the skin and/or underlying tissue, usually over a bony prominence or related to a medical device, caused by pressure and/or shear forces.
Patients in intensive care units (ICUs) are among the most vulnerable groups because they are exposed to multiple risk factors, including immobility, sedation, mechanical ventilation, hemodynamic instability, and medical devices. As a result, the risk of developing PIs in the ICU is reported to be about four times higher than in other patient groups, and most cases occur between 5 and 25 days of hospitalization.
International evidence shows that PI prevalence and incidence are higher in ICUs than in general wards. PIs, especially advanced-stage injuries, are also associated with significantly increased treatment costs. In Türkiye, although rates vary across institutions, PI occurrence in ICUs remains clinically significant, and medical device-related pressure injuries (MDRPIs) constitute a considerable proportion of cases.
Preventing hospital-acquired PIs is widely accepted as an important indicator of healthcare quality and remains a major clinical priority. The 2025 EPUAP guideline emphasizes that risk assessment should be considered not only as a screening step but as a comprehensive clinical decision-making process that guides individualized preventive care plans. Although more than 40 instruments have been developed to assess PI risk, tools designed for general patient populations may not adequately reflect the unique risk profile of critically ill ICU patients.
Based on this rationale, a validity and reliability study of the CALCULATE Pressure Injury Risk Assessment Scale, which was developed in the United Kingdom, was conducted in Türkiye.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients | – | Other: ICU pressure injury prevention protocol as standard carePopulation consisted of patients admitted to a Level III Anesthesiology and Reanimation ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants were recruited from the Anesthesiology and Reanimation Intensive Care Unit of a training and research hospital in Istanbul, Türkiye. Participants were enrolled from patients receiving routine care in this ICU.
Key inclusion criteria (3 listed)
- participants were adults (≥ 18 years)
- ICU length of stay of ≥24 h
- No Pressure ınjury at admission
Key exclusion criteria (2 listed)
- Patients discharged before completing 24 hours in the ICU
- Patients who were not cared for on specialized beds used in the ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU pressure injury prevention protocol as standard carePatients were followed from the time of ICU admission until discharge. During the follow-up period, pressure injury risk was assessed only through the CALCULATE and Braden scales; no additional intervention was applied as part of the study. Throughout hospitalization, all patients received the unit's routine ICU pressure injury prevention protocol as standard care. | Other | ICU Patients |
Primary outcome
Validity of the CALCULATE Pressure Injury Risk Assessment Scale
Time frame: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.
Validity of the CALCULATE Pressure Injury Risk Assessment Scale for assessing pressure injury risk in ICU patients, evaluated using daily risk assessments during ICU stay and comparison with the Braden Scale. The Braden Scale used in clinical settings and generates a total score ranging from 6 to 23, with lower scores indicating a higher risk of PI development. According to the CALCULATE for Pressure Injury risk assessment total score, patients with ≥4 risk factors are categorized as "very high risk," whereas those with ≤3 risk factors are classified as "high risk"
Reliability of the CALCULATE Pressure Injury Risk Assessment Scale
Time frame: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.
Reliability of the CALCULATE Pressure Injury Risk Assessment Scale for assessing pressure injury risk in ICU patients, evaluated using daily risk assessments during ICU stay and comparison with the Braden Scale. The Braden Scale used in clinical settings and generates a total score ranging from 6 to 23, with lower scores indicating a higher risk of PI development. According to the CALCULATE for Pressure Injury risk assessment total score, patients with ≥4 risk factors are categorized as "very high risk," whereas those with ≤3 risk factors are classified as "high risk" .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 37467407Baykara ZG, Karadag A, Bulut H, Duluklu B, Karabulut H, Aktas D, Celik SS, Guler S, Ay A, Gul S, Ozturk D, Irmak B, Aydogan S, Cebeci F, Karakaya D, Avsar P. Pressure Injury Prevalence and Risk Factors: A National Multicenter Analytical Study. J Wound Ostomy Continence Nurs. 2023 Jul-Aug 01;50(4):289-295. doi: 10.1097/WON.0000000000000995.
- Results publication: PubMed 41332352Hyun JE, Park SK. Characteristics of and Risk Factors for Medical Device-Related Pressure Injuries in Trauma Patients in Intensive Care Units: A Retrospective Case-Control Study. West J Nurs Res. 2026 Feb;48(2):131-141. doi: 10.1177/01939459251389331. Epub 2025 Dec 3.
- Results publication: PubMed 25787920Richardson A, Barrow I. Part 1: Pressure ulcer assessment - the development of Critical Care Pressure Ulcer Assessment Tool made Easy (CALCULATE). Nurs Crit Care. 2015 Nov;20(6):308-14. doi: 10.1111/nicc.12173. Epub 2015 Mar 19.
- Results publication: PubMed 25787803Richardson A, Straughan C. Part 2: pressure ulcer assessment: implementation and revision of CALCULATE. Nurs Crit Care. 2015 Nov;20(6):315-21. doi: 10.1111/nicc.12172. Epub 2015 Mar 19.
- Derived from this study: PubMed 42746693Alkan AO, Karabacak U. Turkish Translation and Cultural Adaptation, Validity and Reliability of the CALCULATE Pressure Injury Risk Scale in Intensive Care Unit Patients. Nurs Open. 2026 Sep;13(9):e70742. doi: 10.1002/nop2.70742.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Injuries and Intensive Care (ICU), run by Acibadem 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the CALCULATE Pressure Injury Risk Assessment Scale (time frame: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.). The study lists 2 primary outcomes in all. 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 NCT07454746, which also lists 5 linked publications.
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 6 Mar 2026.