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NCT Number: NCT07454746

Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale

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)?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem Mehmet Ali Aydınlar University Department of Nursing, Faculty of Health Sciences

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICU pressure injury prevention protocol as standard care

Other

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.

Primary outcomes

  1. 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"

  2. 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" .

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale in Intensive Care Unit Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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