NCT06908512

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 19, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 19, 2025

Last Update Submit

March 26, 2025

Conditions

Keywords

Pressure InjuryReliability and ValidityIntensive Care UnitsAssessment Scale

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in intensive care units

You may qualify if:

  • 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

You may not qualify if:

  • \- Having communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Turkey, 63000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 32666602BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ayşe Şahin, Assist. Prof.

    Harran University

    STUDY CHAIR

Central Study Contacts

Ibrahim C Dikici, Assist. Prof.

CONTACT

Yunus E Tütüneken, Research Assistant

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 19, 2025

First Posted

April 3, 2025

Study Start

March 30, 2025

Primary Completion

July 12, 2025

Study Completion

November 12, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations