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

NCT07249619 | Not Yet Recruiting

• 1 other identifier: 2024/6
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subarachnoid Haemorrhagic Stroke

Keywords

Body Awareness Therapy; Communication; Delirium

Outcome Measures

Primary Outcomes (39)

• 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

  Baseline

• 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

Study Arms (2)

Routine Treatment

ACTIVE COMPARATOR

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)

ICU.Delibma

EXPERIMENTAL

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); Procedure: Biopsychosocial-Based Multimodal Approach

Interventions

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

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

ICU.Delibma; Routine Treatment

Biopsychosocial-Based Multimodal Approach PROCEDURE

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

ICU.Delibma

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Emre Şenocak: lead

Study Sites (1)

Karadeniz Technical University, Farabi Hospital

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Communication; Delirium

Condition Hierarchy (Ancestors)

Behavior; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Arzu Erden Güner, PhD

  Karadeniz Technical University

  STUDY CHAIR

Central Study Contacts

Arzu Erden Güner, PhD

CONTACT

+90 506 248 26 80; arzuerden@ktu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)