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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subarachnoid Haemorrhagic Stroke
• Intervention / Treatment: Other: Routine Therapy (Medical, environmental accodamation, face-to-face commucation); Procedure: Biopsychosocial-Based Multimodal Approach

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arzu Erden Güner, PhD; Phone Number: +90 506 248 26 80; Email: arzuerden@ktu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Trabzon, Turkey (Türkiye)
    • Karadeniz Technical University, Farabi Hospital
    • Contact: Arzu Erden Güner, PhD; Phone Number: +90 506 248 26 80; Email: arzuerden@ktu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Treatment; A treatment program will be implemented in line with the recommendations of international guidelines for the treatment of delirium.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital Anxiety and Depression Scale	Baseline
Charlson Comorbidity Index	Baseline
Charlson Comorbidity Index	8th day after admission to ICU
Charlson Comorbidity Index	15th day after admission to ICU
Mini-Mental State Examination Test	Baseline
APACHE II Score	Baseline
APACHE II Score	8th day after admission to ICU
APACHE II Score	15th day after admission to ICU
SOFA Score	Baseline
SOFA Score	8th day after admission to ICU
SOFA Score	15th day after admission to ICU
Glaskow Coma Score	During everyday she was admitted to the ICU
Modified Rankin Scale	Baseline
Modified Rankin Scale	8th day after admission to ICU
Modified Rankin Scale	15th day after admission to ICU
Simple five-item questionnaire (SARC-F)	Baseline
Simple five-item questionnaire (SARC-F)	8th day after admission to ICU
Simple five-item questionnaire (SARC-F)	15th day after admission to ICU
Medical Research Council Muscle Strenght	Baseline
Medical Research Council Muscle Strenght	8th day after admission to ICU
Medical Research Council Muscle Strenght	15th day after admission to ICU
Physical Function in Intensive Care Test (PFIT-s)	Baseline
Physical Function in Intensive Care Test (PFIT-s)	8th day after admission to ICU
Physical Function in Intensive Care Test (PFIT-s)	15th day after admission to ICU
Hospital Anxiety and Depression Scale	8th day after admission to ICU
Hospital Anxiety and Depression Scale	15th day after admission to ICU
Montreal Cognitive Assessment	Baseline
Montreal Cognitive Assessment	8th day after admission to ICU
Montreal Cognitive Assessment	15th day after admission to ICU
Nothingham Health Profile	Baseline
Nothingham Health Profile	8th day after admission to ICU
Nothingham Health Profile	15th day after admission to ICU
Barthel Index	Baseline
Barthel Index	8th day after admission to ICU
Barthel Index	15th day after admission to ICU
Modified Borg Test	During everyday she was admitted to the ICU
Confusion Assessment Method for the intensive care unit (CAM-ICU)	During everyday she was admitted to the ICU
Richmond Ajitation-Sedation Scale	During everyday she was admitted to the ICU
Numeric Rating Scale	During everyday she was admitted to the ICU

Collaborators and Investigators

• Sponsor: Emre Şenocak
• Investigators: Principal Investigator: Hülya Ulusoy, PhD, Karadeniz Technical University; Principal Investigator: Nurel Ertürk, PhD, Tarsus University; Principal Investigator: Gizem Ergün, Physiotherapist, Karadeniz Technical University; Principal Investigator: Neslihan Hatınoğlu, PhD, Karadeniz Technical University; Principal Investigator: Müge Koşucu, PhD, Karadeniz Technical University; Principal Investigator: Duygu Yıldırım, Phyiotherapist, Trabzon Kanuni Training and Research Hospital; Study Chair: Arzu Erden Güner, PhD, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Communication; Delirium; Body Awareness Therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Delirium; Communication
• Other Study ID Numbers: 2024/6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No