跳至主要内容
临床试验/CTRI/2025/08/092450
CTRI/2025/08/092450招募中不适用

Reliability and Validity of the Bengali Version of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium

IPSITA BAGCHI1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2025年8月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
65
试验地点
1
主要终点
1.)To determine the reliability of Bengali version of CAM-ICU

研究概览

简要总结

The proposed study titled "Reliability and Validity of Bengali Version of the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for Diagnosis of Delirium" will be a Descriptive study. This study will be a sub study of the original study titled "Neurocognitive and Psychological Outcomes and Their Correlates in critically Ill Patients of a Tertiary Care Hospital in Kolkata" **(**CTRI/2025/02/080285). The rationale of the study is the lack of  availability of the Bengali dialect of CAM-ICU for assessment of delirium in the Bengali speaking regions of India. The primary objectives of the proposed study is :1.) to determine reliability of the bengali version of CAM-ICU, 2.) to determine the validity of the Bengali version of CAM-ICU. The inclusion criteria of the proposed study is Critically ill patients, well versed in bengali and/or english, admitted in ICU during the period of data collection and willing to participate in the study. the exclusion criteria of the study are the patients with impaired consciousness level, mental retardation, difficulty in speaking or communication and/or with previous history of psychological disorders. A written informed consent ensuring the willingness for participation in the study will be obtained from the patients/relatives. original english version will be translated to bengali (forward translation) and then will be translated back to english (back translation). Then, the original version and the backward translated version of CAM-ICU will be compared by the experts. After that the bengali version of the CAM-ICU will be used to collect data. sample size will comprise of 65 patients. sampling technique will be by consecutive sampling technique . Statistical plan will comprise of interrater reliability, internal consistency and construct validity

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Critically ill patients, well versed in bengali and/or english, admitted in ICU during the period of data collection and willing to participate in the study.

排除标准

  • Patients with previous history of psychological disorders.
  • Patient associated with impaired conscious level.
  • Patient with mental retardation.
  • Patient with difficulty in speaking or communication.

结局指标

主要结局

1.)To determine the reliability of Bengali version of CAM-ICU

时间窗: 1 WEEK

2.)To determine the validity of Bengali version of CAM-ICU

时间窗: 1 WEEK

次要结局

未报告次要终点

研究者

发起方
IPSITA BAGCHI
申办方类型
Other [self-sponsored]
责任方
Principal Investigator
主要研究者

IPSITA BAGCHI

RABINDRANATH TAGORE INTERNATIONAL INSTITUTE OF CARDIAC SCIENCES

研究点 (1)

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