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

NCT ID: NCT06115863

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-09-10

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Early Cognitive Stimulation Interventions

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Early Cognitive Stimulation Interventions

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sahar Younes Othman Ramadan, ASS-PROF

Role: STUDY_DIRECTOR

Damanhour University

Locations

Not Found

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 7222136 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36385466 (View on PubMed)

Other Identifiers

prevention of delirium in ICU

Identifier Type: -

Identifier Source: org_study_id