A Biopsychosocial-Based Multimodal Approach to Reducing the Risk of Delirium in ICU

Emre Şenocak

Status: Not yet enrolling

Conditions: Subarachnoid Haemorrhagic Stroke

Treatments: Procedure: Biopsychosocial-Based Multimodal Approach; Other: Routine Therapy (Medical, environmental accodamation, face-to-face commucation)

Study type: Interventional

Funder types: Other

Identifiers

NCT07249619

2024/6

Details and patient eligibility

About

As part of this study, an intervention program aimed at preventing delirium in patients with subarachnoid hemorrhage treated in the intensive care unit will be implemented. Routine medical treatments, environmental adjustments, and a video-based communication program will be implemented to prevent delirium. In addition, basic body awareness training will be administered.

Patients will be divided into two groups. One group will receive only the routine treatment program recommended by international guidelines (medical, enviromental adjustment and face-to-face interview etc.), while the other group will receive body awareness therapy addition to routine interventions.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-85,
• Patients scheduled for intensive care for at least 15 days due to SAH, unruptured intracranial aneurysm, and/or Arterovenous Malformation,
• Those with a Mini Mental State Examination score of > 24,
• Those with a Glasgow Coma Score of 15,
• Those with motor function in at least one extremity,
• Those with pain < 5/10 (according to the NRS)

Exclusion criteria

• Patients whose GCS fell to 14 or below for any reason during the study period;
• Patients who developed septic shock and MODS;
• Patients requiring endotrachial intubation and mechanical ventilation due to ARDS;
• Those requiring vasopressors such as NE at a rate of >0.25 mcg/kg/min;
• Terminal cancer cases;
• Patients with advanced chronic heart and lung failure and COPD;
• Those with a METS (exercise capacity) of <4;
• Those with a history of dementia, Alzheimer's disease, or psychiatric illness;
• Those with vision, hearing, or speech problems that would interfere with communication;
• Those with a history of epilepsy;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Routine Treatment

Active Comparator group

Description:

A treatment program will be implemented in line with the recommendations of international guidelines for the treatment of delirium.

Treatment:

Other: Routine Therapy (Medical, environmental accodamation, face-to-face commucation)

ICU.Delibma

Experimental group

Description:

In addition to the treatment program implemented in line with the recommendations of international guidelines for the treatment of delirium, "Basic Body Awareness Therapy" and "Communication Program" will be applied.

Treatment:

Other: Routine Therapy (Medical, environmental accodamation, face-to-face commucation)

Procedure: Biopsychosocial-Based Multimodal Approach