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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06115863
Enrollment
130
Registered
2023-11-03
Start date
2023-11-20
Completion date
2025-09-10
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Early cognitive stimulation, critically ill patients

Brief summary

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.

Detailed description

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.

Interventions

OTHEREarly Cognitive Stimulation Interventions

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.

Sponsors

Damanhour University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Single blinding

Intervention model description

A randomized controlled trial with two parallel groups will be used in the current study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
1. To assess the effect of early cognitive stimulation interventions on delirium among 65 critically ill patients by use CAM -ICU 7.5 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. To investigate the effect of early cognitive stimulation interventions on delirium severity among 65 critically ill patients.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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026