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Not yet recruiting NCT07249619

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

No phase Interventional Subarachnoid Haemorrhagic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Therapy (Medical, environmental accodamation, face-to-face commucation), Biopsychosocial-Based Multimodal Approach.
Who it may be relevant to
Registry conditions: Subarachnoid Haemorrhagic Stroke. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Biopsychosocial-Based Multimodal Approach to Reducing the Risk of Delirium in Patients With Subarachnoid Hemorrhage in the Intensive Care Unit (ICU.Delibma)

Overview

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.

Interventions

  • Other 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.
  • Procedure 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.

Primary outcome measures

  • Charlson Comorbidity Index [Time frame: Baseline]
  • Charlson Comorbidity Index [Time frame: 8th day after admission to ICU]
  • Charlson Comorbidity Index [Time frame: 15th day after admission to ICU]
  • Mini-Mental State Examination Test [Time frame: Baseline]
  • APACHE II Score [Time frame: Baseline]
  • APACHE II Score [Time frame: 8th day after admission to ICU]
  • APACHE II Score [Time frame: 15th day after admission to ICU]
  • SOFA Score [Time frame: Baseline]
  • SOFA Score [Time frame: 8th day after admission to ICU]
  • SOFA Score [Time frame: 15th day after admission to ICU]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Karadeniz Technical University, Farabi Hospital — Trabzon

Identifiers

NCT: NCT07249619 · 2024/6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗