Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT06908512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-03
First Post:
2025-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU-Specific Pressure Injury Risk Assessment Scale (RAPS-ICU)', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pressure Injury', 'Reliability and Validity', 'Intensive Care Units', 'Assessment Scale'], 'conditions': ['Pressure Injury', 'Reliability and Validity', 'Intensive Care Units (ICUs)', 'Assessment Scale']}, 'referencesModule': {'references': [{'pmid': '32666602', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale', 'detailedDescription': "This was a prospective, cross-sectional study aimed at translation and cultural adaptation of the RAPS-ICU into Turkish, while also assessing its validity and reliability.Patients who meet the inclusion criteria and who are hospitalized in the Intensive Care Clinics of Istinye University Bahçeşehir Liv Hospital and Harran University Hospital will participate in the study. In this study, Turkish adaptation of the 'Intensive care unit-specific pressure injury risk assessment scale' is planned. After language adaptation, its validity and reliability will be tested. The reliability of the intensive care unit-specific pressure injury risk assessment scale will be assessed by inter-rater reliability and internal consistency (determined by calculating Cronbach alpha coefficient), and its validity will be assessed by convergent and divergent validity of the scale. Relative reliability was obtained by calculating the intraclass correlation coefficient (ICC). Relative reliability will be obtained by calculating the intraclass correlation coefficient (ICC). The receiver operator characteristics (ROC) curve has been used to estimate sensitivity and specificity and will represent the false positive rate versus the true positive rate across various thresholds for different scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in intensive care units', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older,\n* Staying in the Intensive Care Unit for at least 1 day,\n* Agreeing to participate in the study by themselves or a family member.\n* Volunteering to participate in the research\n* Full orientation and no psychiatric problems\n\nExclusion Criteria:\n\n\\- Having communication problems'}, 'identificationModule': {'nctId': 'NCT06908512', 'briefTitle': 'Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)', 'organization': {'class': 'OTHER', 'fullName': 'Harran University'}, 'officialTitle': 'Turkish Adaptation, Validity and Reliability of the Intensive Care Unit-specific Pressure Injury Risk Assessment Scale', 'orgStudyIdInfo': {'id': 'NT268347145'}}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Sanliurfa', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Harran University', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}], 'centralContacts': [{'name': 'Ibrahim C Dikici, Assist. Prof.', 'role': 'CONTACT', 'email': 'ibrahimcanerdikici@gmail.com', 'phone': '+905376729057'}, {'name': 'Yunus E Tütüneken, Research Assistant', 'role': 'CONTACT', 'email': 'yunus.tutuneken@istinye.edu.tr', 'phone': '+905435912455'}], 'overallOfficials': [{'name': 'Ayşe Şahin, Assist. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Harran University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harran University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'İbrahim Caner Di̇ki̇ci̇', 'investigatorAffiliation': 'Harran University'}}}}