Validation of the 3D-CAM Turkish Version

NCT04853706 | Unknown

• 1 other identifier: 2021/28
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium; Validity

Outcome Measures

Primary Outcomes (1)

• Assessment of delirium

  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.

  3 days

Study Arms (1)

Delirium

OTHER

Diagnostic Test: 3d cam; Diagnostic Test: DSM 5

Interventions

3d cam DIAGNOSTIC_TEST

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

Delirium

DSM 5 DIAGNOSTIC_TEST

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

Delirium

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Related Publications (1)

• Mu DL, Ding PP, Zhou SZ, Liu MJ, Sun XY, Li XY, Wang DX. Cross-cultural adaptation and validation of the 3D-CAM Chinese version in surgical ICU patients. BMC Psychiatry. 2020 Mar 24;20(1):133. doi: 10.1186/s12888-020-02544-w.

  PMID: 32204700 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

SINEM S OZTURK

CONTACT

4441256; sarisinem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 21, 2021
• Study Start: April 18, 2021
• Primary Completion: October 18, 2021
• Study Completion: December 18, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share