Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale

March 4, 2026 updated by: Ukke Karabacak, Acibadem University

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)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

76

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)
    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34758
        • Acıbadem Mehmet Ali Aydınlar University Department of Nursing, Faculty of Health Sciences

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

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • participants were adults (≥ 18 years)
  • ICU length of stay of ≥24 h
  • No Pressure ınjury at admission

Exclusion Criteria:

  • Patients discharged before completing 24 hours in the ICU
  • Patients who were not cared for on specialized beds used in the ICU

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU Patients
Population consisted of patients admitted to a Level III Anesthesiology and Reanimation ICU
Other: ICU pressure injury prevention protocol as standard care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
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
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" .
From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.

Collaborators and Investigators

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

Sponsor

Acibadem 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.

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)

October 1, 2024

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-15/520

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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