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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-02

Study Completion Date

2028-01-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Subarachnoid Haemorrhagic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine Treatment

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

In the treatment of delirium, a treatment program will be implemented in line with the recommendations of international guidelines.

ICU.Delibma

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

In the treatment of delirium, a treatment program will be implemented in line with the recommendations of international guidelines.

Biopsychosocial-Based Multimodal Approach

Intervention Type PROCEDURE

Delirium treatment will be implemented in accordance with international guidelines. Additionally, a basic body awareness therapy and communication program will be implemented.

Interventions

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

In the treatment of delirium, a treatment program will be implemented in line with the recommendations of international guidelines.

Intervention Type OTHER

Biopsychosocial-Based Multimodal Approach

Delirium treatment will be implemented in accordance with international guidelines. Additionally, a basic body awareness therapy and communication program will be implemented.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Emre Şenocak

Assoc. Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR