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

NCT06115863 | Completed

• 1 other identifier: prevention of delirium in ICU
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Early cognitive stimulation; critically ill patients

Outcome Measures

Primary Outcomes (2)

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

  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.

  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 Outcomes (1)

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

  immediately after the intervention.

Study Arms (2)

placebo group

ACTIVE COMPARATOR

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 group

EXPERIMENTAL

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

Interventions

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.

early cognitive stimulation Interventions group; placebo group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Not Found

Cairo, Egypt

Location

Related Publications (2)

• Hering KG, Mitrovic D. [Diseases of the brachial plexus after surgery and irradiation of breast cancer (author's transl)]. Strahlentherapie. 1981 Feb;157(2):86-90. German.

  PMID: 7222136 BACKGROUND

• Deemer K, Myhre B, Oviatt S, Parsons M, Watson M, Zjadewicz K, Soo A, Fiest K, Posadas-Calleja J. Occupational therapist-guided cognitive interventions in critically ill patients: a feasibility randomized controlled trial. Can J Anaesth. 2023 Jan;70(1):139-150. doi: 10.1007/s12630-022-02351-9. Epub 2022 Nov 16.

  PMID: 36385466 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Sahar Younes Othman Ramadan, ASS-PROF

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: November 3, 2023
• Study Start: November 20, 2023
• Primary Completion: August 17, 2025
• Study Completion: September 10, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: just i finish my data entry
• Access Criteria: aims , inclusion criteria and methodology

Locations

EG (1)