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

September 14, 2025 updated by: Damanhour University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Not Found

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: early cognitive stimulation Interventions group

Beginning on the first day of the patient's admission to the ICU, the early cognitive stimulation interventions will be implemented for nearly 45 minutes twice daily for five days. One session will be conducted during the morning shift and the other during the evening shift. Each session will include the following:

  1. Cognitive stimulation activities will be administered to patients in the intervention group by a member of his family for 15 minutes twice a day for five consecutive days.
  2. Cognitive training exercises: The researcher will carry out these exercises for a total of 300 minutes over the course of five days, splitting the time between 30 minutes in the morning shift and 30 minutes in the evening shift.
Other: Early 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.
Active Comparator: placebo group

Delirium will be assessed for patients in the control group twice per day for five consecutive days' pre and post conventional nursing care.

The researcher will observe the conventional nursing care provided by CCNs in the study setting which may affect delirium incidence twice daily for five consecutive days. These traditional nursing practices may include a close conversation between the nurse and the patient, patient re-orientation, such as providing information about time, date, and location, tactile stimulation during various procedures, and changing patients' positions.
Other: Early 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 day from patients' admission to ICU.
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
5 days from patients' admission to ICU.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Director: Sahar Younes Othman Ramadan, ASS-PROF, Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

August 17, 2025

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prevention of delirium in ICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all content of protocol will be accessible to public

IPD Sharing Time Frame

just i finish my data entry

IPD Sharing Access Criteria

aims , inclusion criteria and methodology

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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