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OpenTrials
Completed

NCT Number: NCT06115863

Effect of Early Cognitive Stimulation Interventions on Delirium Among Critically Ill Patients

Delirium is an acute change in attention and awareness that develops over a relatively short time interval and associated with additional cognitive deficits such as memory deficit, disorientation, or perceptual disturbances.

Delirium negative impact has been widely documented in the medical literature. It has been associated with increased mortality and morbidity, longer hospital stays, increase health care costs, and a longer duration of MV.

Delirium in the ICU can be prevented and treated with a combination of pharmaceutical and non-pharmaceutical interventions.

Cognitive interventions, as part of a delirium prevention strategy, are specific therapies focusing on the domains of cognitive functioning impacted by delirium such as orientation, attention, registration, recall and language.

Cognitive stimulation interventions such as orienting patients to the date, time and place, visual and auditory stimulations that focused on specific domains (orientation and registration). In addition, cognitive stimulation included cognitive training and stimulation exercises that focus on specific domains (attention, language, recall, and registration) such as analyzing exercise, recalling exercise, and cognitive-training exercises by using mobile applications .

The involvement of family members in the cognitive stimulation of critically ill patients is an underutilized resource that may benefit patients as well as gain a sense of control and purpose.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Not Found

Cairo, Egypt

About this study

Nurses have direct contact with patients 24 hours a day, so they are in an ideal position to prevent, detect, manage, and care for patients who have delirium. The identification of predisposing or precipitating variables must be a part of the nursing intervention in order to reduce the likelihood of delirium occurring. When possible, nurses can help identify at-risk individuals and lower risk. Although a regular nursing assessment and good observational skills combined with a strong therapeutic relationship can enable nurses to recognize sudden changes in attention or consciousness, which are typical indications of delirium.

Although the effects of cognitive stimulation interventions have been extensively studied in the prevention of delirium for ICU patients, there are few studies have implemented to assess its effects when it is applied early within the first 24 hours from ICU admission worldwide, and up to our knowledge there are no national studies that have been conducted to assess early effects of such interventions on delirium in ICU. Therefore, this study will be conducted to evaluate the effect of early cognitive stimulation interventions on delirium in critically ill patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years.
  • Newly admitted patients not more than 24 hours.
  • Patient's Richmond Agitation Sedation Scale (RASS) from -1 to +1.

Exclusion criteria

  • Patient with pre-existing brain injury and cognitive impairment.
  • Patient who is delirious on admission positive for Confusion Assessment Method for the ICU 7 (CAM ICU 7).
  • Patient with hearing and visual impairment.
  • Patients who is Hemodynamically unstable.

Treatment and study plan

Early Cognitive Stimulation Interventions

Other

early cognitive stimulation interventions refer to multi-dimensions of stimulative evidenced-based interventions, which are done during the first 24 hours from patient admission to the ICU. They are designed to stimulate cognitive function domains that are impacted by delirium such as attention, registration, recall, and language.

Primary outcomes

  1. 1. To assess the effect of early cognitive stimulation interventions on delirium among 65 critically ill patients by use CAM -ICU 7.

    Time frame: 5 day from patients' admission to ICU.

    Critically ill patients who undergo early cognitive stimulation interventions have a significantly lower risk of incidence delirium than those who do not. Delirium will be assessed for patients by use the Confusion Assessment Method for the ICU 7 (CAM-ICU 7).

  2. 2. To investigate the effect of early cognitive stimulation interventions on delirium severity among 65 critically ill patients.

    Time frame: 5 days from patients' admission to ICU.

    Critically ill patients who undergo early cognitive stimulation interventions show improved the delirium severity scoring compared to those who do not. the measurement tool for delirium severity is CAM-ICU 7

Secondary outcomes

  1. 1. To investigate the effect of early cognitive stimulation interventions on patient's length of ICU stay.

    Time frame: immediately after the intervention.

    Critically ill patients who undergo early cognitive stimulation interventions have a significantly shorter length of ICU stay than those who do not.

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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