Validation of the 3D-CAM Turkish Version

NCT ID: NCT04853706

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-18
• Study Completion Date: 2021-12-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Delirium

Group Type: OTHER

3d cam

Intervention Type: DIAGNOSTIC_TEST

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

DSM 5

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

3d cam

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

Intervention Type: DIAGNOSTIC_TEST

DSM 5

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SINEM SARI

Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

SINEM S OZTURK

Role: CONTACT

sarisinem@yahoo.com

4441256

References

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.

Reference Type: BACKGROUND

PMID: 32204700 (View on PubMed)

Other Identifiers

2021/28

Identifier Type: -

Identifier Source: org_study_id