Validation and Reliability of the Turkish 4AT Scale for Post-Anesthesia Awakening Delirium

NCT06187389 | Completed

• 1 other identifier: kilis7aralıkU1
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Delirium is a common and serious condition in hospitalized patients that often leads to extended hospital stays and increased healthcare costs. Accurate and timely detection is essential for optimal patient outcome. Aims: This study aimed to adapt the internationally recognized 4 AT Delirium Diagnosis Scale to Turkish and to evaluate the validity and reliability of this tool for the Turkish patient population. Design: This study was structured and conducted at a state hospital from March to June 2023. Methods: The study included 188 participants, determined through a power analysis. The 4AT Delirium Test and additional assessment tools were used to ascertain the delirium status of the patients. Comprehensive statistical evaluations were conducted using SPSS 25.0, which included analyses, such as item difficulty indices, item discrimination, and chi-square tests. Ethical approval for this study was granted by the Non-Interventional Ethics Committee, ensured full compliance with the ethical standards set by the World Medical Association's Declaration of Helsinki. All participants provided informed consent before participation. Additionally, our results strictly adhered to the guidelines of the STROBE Checklist.

Conditions

Delirium; Awakening, Post-Anesthesia Delayed; Delirium, Postoperative; Nurse's Role; Nursing Caries

Outcome Measures

Primary Outcomes (6)

• Patient evaluation form: The patient Evaluation Form

  Crafted by the research team to delve into potential delirium triggers and capture anamnestic information gathered during the patient's initial check-in. Beyond capturing basic demographics such as age, sex, marital status, and education, the form delves deep into the patient's overall health profile, lifestyle, and associated risk factors.

  up to 12 weeks

• Richmond Sedation-Agitation Scale [RASS]:

  This scale offers a thorough observational evaluation. Initially, the patient's sedative status was gauged. If the patient is profoundly sedated, unresponsive, or registers a score between -4 and -5 on the RASS, no assessment can be performed. In these deep sedative states, often termed comas or stupors, the patient does not react to stimuli, rendering delirium evaluation moot. However, as soon as patients become alert \[RASS\> -3\], delirium assessments are feasible. The scale operates on a scoring system ranging from +4 to -5.

  up to 12 weeks

• The Glasgow Coma Scale [GCS],

  which is globally recognized and adopted in ICUs, was conceived by Teasdale and Jennet in 1974 to exclusively gauge consciousness levels in patients with traumatic brain injury. This scale delineates separate evaluation criteria for the adult and pediatric cohorts. Rooted in three core categories, GCS is a physiological scoring mechanism to monitor patients' clinical trajectory from admission throughout their hospital tenure. Only patients with a GCS score ≥ 10 were deemed suitable for delirium evaluation

  up to 12 weeks

• Confusion Assessment Metot in the Intensive Care Unit [Cam-ICU]:

  Tailored for ICU-based confusion assessments, the Cam-ICU operates on DSM-V parameters and is completed in under five minutes

  up to 12 weeks

• Nursing Delirium Screening Scale [Nu-DESC]

  The Nu-DESC is a 5-item observational tool geared towards rapid delirium detection. The scale encompasses elements, such as disorientation, inappropriate conduct, flawed communication, hallucinations, and psychomotor retardation. Each facet was scored between 0 and 2, with aggregate scores capped at 10. Individuals with scores of ≥ 2 were labeled as delirious.

  up to 12 weeks

• 4AT Delirium Test:

  The Turkish adaptation of the 4AT was curated in alignment with the guidelines delineating the cross-cultural adaptation of health-centric scales. Under the guidance of the original creator, Prof. Alasdair M.J. MacLullich from the University of Edinburgh translated the Turkish 4AT by a trio comprising two English academics and a psychiatrist. The subsequent phase entailed bilingual academic nurses unfamiliar with the 4AT, executing a back-translation. After test-driving the translation on assorted samples, the final version was greenlit for the 4AT application. The 4AT, a user-friendly delirium and cognitive disorder assessment tool, is a breeze for practitioners to administer and does not require specialized training.

  up to 12 weeks

Interventions

1 Grups OTHER

This methodological study was conducted using a cross-sectional observational approach at a leading teaching and research hospital. The study duration was from March to June 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients admitted to the ICU for surgery. Participants were selected based on preoperative cognitive status assessments, with those showing normal evaluations included in the study. The population exhibits diversity in terms of age, gender, and types of surgery. Post-operative patients in the recovery room were evaluated for consciousness and sedation agitation levels using established scales such as RASS and GKS. The study specifically focuses on screening for post-anesthesia emergence delirium, making the population representative of typical ICU surgical cases where delirium assessment is critical

You may qualify if:

• Our study cohort comprised patients who satisfied certain prerequisites. These included being aged 18 years or older, possessing the capability to communicate, scoring between -3 and +4 on the Richmond Agitation-Sedation Scale \[RASS\], achieving a minimum score of 10 on the Glasgow Coma Scale \[GCS\], and no neurological or psychiatric backdrop that might skew a delirium assessment. If any participant opted to exit the study, their associated data were omitted.

You may not qualify if:

• Individuals who encountered acute post-anesthesia complications, were diagnosed with advanced cognitive deficits or dementia, lost communication abilities entirely, or displayed reluctance or inability to furnish information during the study were excluded. Moreover, patients diagnosed with an alternate neurological or psychiatric ailment after delirium assessment were also included. Participants or their guardians, who either declined involvement or retracted prior consent, were excluded from the study.

Sponsors & Collaborators

• Kilis 7 Aralik University: lead

Study Sites (1)

Islam Elagöz

Kilis, 79100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium; Delayed Emergence from Anesthesia; Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• islam elagöz, MsC

  kils 7 aralık University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: March 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)