NCT07454746

Brief 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. 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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 27, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

pressure injuryintensive carerisk assessmentCALCULATEvalidityreliabilityROCinter-rater reliability

Outcome Measures

Primary Outcomes (2)

  • 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"

    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" .

    From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.

Study Arms (1)

ICU Patients

Population consisted of patients admitted to a Level III Anesthesiology and Reanimation ICU

Other: ICU pressure injury prevention protocol as standard care

Interventions

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.

ICU Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • Hyun 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.

  • Richardson 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.

  • Richardson 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.

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 6, 2026

Study Start

October 1, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations