Validation of the 3D-CAM Turkish Version

Not Applicable

• Conditions: Delirium; Validity
• Interventions: Diagnostic Test: 3d cam; Diagnostic Test: DSM 5

• Registration Number: NCT04853706
• Lead Sponsor: Aydin Adnan Menderes University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-13
• Study Start: 2021-04-18
• Study First Submitted QC: 2021-04-20
• Last Update Submitted: 2021-04-20
• Study First Posted: 2021-04-21
• Last Update Posted: 2021-04-21
• Primary Completion: 2021-10-18
• Study Completion: 2021-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delirium	3d cam	-
Delirium	DSM 5	-

Primary Outcome Measures

Name	Time	Method
Assessment of delirium	3 days	Delirium 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.