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Validation of the 3D-CAM Turkish Version

Validation of the 3D-CAM Turkish Version in Surgical ICU Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04853706
Enrollment
245
Registered
2021-04-21
Start date
2021-04-18
Completion date
2021-12-18
Last updated
2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Validity

Brief summary

3D CAM into Turkish validity and reliability on postoperative delirium will be test as a prospective diagnostic study. After approval by Dr. Edward R. Marcantonio, (15) will translation and back-translation. The original 3D-CAM will translate into Turkish by two medical doctor .The two translational versions will be discussed and merged into a final version. Back translation will performed in regardless of any information from its original version by another two medical doctor. Both the translated and back translated versions will sent to Dr. Marcantonio for approval. Eligibility and the documentation of consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication usage. The Mini-Mental State Exam (MMSE) will be performed. Delirium assessment Delirium assessment with the 3D-CAM Before the study period, all researchers will participate online training program on 3D CAM. Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. Delirium assessment with the DSM-5 The psychiatrist investigator who was blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.

Interventions

DIAGNOSTIC_TEST3d cam

The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm

DIAGNOSTIC_TESTDSM 5

The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years and older * ASA Physical Status 1-3 * Admitted to the ICU after surgery with a predicted length of stay for more than 48 h * MMSE ≥ 20 (to exclude dementia)

Exclusion criteria

* Refused to participate * Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication * Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism * Deep sedation or coma * ASA physical status IV or V

Design outcomes

Primary

MeasureTime frameDescription
Assessment of delirium3 daysDelirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.

Contacts

Primary ContactSINEM S OZTURK
sarisinem@yahoo.com4441256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026