Clinical trial NCT06115863: Effect of Early Cognitive Stimulation Interventions on Delirium and Cognitive Functions Among Critically Ill Patients
Official title: Effect of Early Cognitive Stimulation Interventions on Delirium and Cognitive Functions Among Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium
Keywords: Early cognitive stimulation
critically ill patients
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with two parallel groups will be used in the current study.
Primary purpose: PREVENTION

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.

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 (CAM ICU).
* Patient with hearing and visual impairment.
* Patients who is Hemodynamically unstable.

Primary outcomes:
measure: 1. To assess the effect of early cognitive stimulation interventions on incidence of delirium among 65 critically ill patients by use CAM -ICU.
timeFrame: 5 day from patients' admission to ICU.
measure: 2. To investigate the effect of early cognitive stimulation interventions on concentration of cognitive function among 65 critically ill patients.
timeFrame: 5 days from patients' admission to ICU.
Secondary outcomes:
measure: 1. To investigate the effect of early cognitive stimulation interventions on patient's length of ICU stay.
timeFrame: immediately after the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Damanhour University
name: Sahar Younes Othman Ramadan, ASS-PROF
role: STUDY_DIRECTOR
References:
citation: Deemer K, Zjadewicz K, Fiest K, Oviatt S, Parsons M, Myhre B, Posadas-Calleja J. Effect of early cognitive interventions on delirium in critically ill patients: a systematic review. Can J Anaesth. 2020 Aug;67(8):1016-1034. doi: 10.1007/s12630-020-01670-z. Epub 2020 Apr 24.
citation: 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.