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NCT Number: NCT07249619

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

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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Key information

Conditions

Subarachnoid Haemorrhagic Stroke Behavior Communication Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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.

Primary outcomes

  1. Charlson Comorbidity Index

    Time frame: Baseline

  2. Charlson Comorbidity Index

    Time frame: 8th day after admission to ICU

  3. Charlson Comorbidity Index

    Time frame: 15th day after admission to ICU

  4. Mini-Mental State Examination Test

    Time frame: Baseline

  5. APACHE II Score

    Time frame: Baseline

  6. APACHE II Score

    Time frame: 8th day after admission to ICU

  7. APACHE II Score

    Time frame: 15th day after admission to ICU

  8. SOFA Score

    Time frame: Baseline

  9. SOFA Score

    Time frame: 8th day after admission to ICU

  10. SOFA Score

    Time frame: 15th day after admission to ICU

  11. Glaskow Coma Score

    Time frame: During everyday she was admitted to the ICU

  12. Modified Rankin Scale

    Time frame: Baseline

  13. Modified Rankin Scale

    Time frame: 8th day after admission to ICU

  14. Modified Rankin Scale

    Time frame: 15th day after admission to ICU

  15. Simple five-item questionnaire (SARC-F)

    Time frame: Baseline

  16. Simple five-item questionnaire (SARC-F)

    Time frame: 8th day after admission to ICU

  17. Simple five-item questionnaire (SARC-F)

    Time frame: 15th day after admission to ICU

  18. Medical Research Council Muscle Strenght

    Time frame: Baseline

  19. Medical Research Council Muscle Strenght

    Time frame: 8th day after admission to ICU

  20. Medical Research Council Muscle Strenght

    Time frame: 15th day after admission to ICU

  21. Physical Function in Intensive Care Test (PFIT-s)

    Time frame: Baseline

  22. Physical Function in Intensive Care Test (PFIT-s)

    Time frame: 8th day after admission to ICU

  23. Physical Function in Intensive Care Test (PFIT-s)

    Time frame: 15th day after admission to ICU

  24. Hospital Anxiety and Depression Scale

    Time frame: Baseline

  25. Hospital Anxiety and Depression Scale

    Time frame: 8th day after admission to ICU

  26. Hospital Anxiety and Depression Scale

    Time frame: 15th day after admission to ICU

  27. Montreal Cognitive Assessment

    Time frame: Baseline

  28. Montreal Cognitive Assessment

    Time frame: 8th day after admission to ICU

  29. Montreal Cognitive Assessment

    Time frame: 15th day after admission to ICU

  30. Nothingham Health Profile

    Time frame: Baseline

  31. Nothingham Health Profile

    Time frame: 8th day after admission to ICU

  32. Nothingham Health Profile

    Time frame: 15th day after admission to ICU

  33. Barthel Index

    Time frame: Baseline

  34. Barthel Index

    Time frame: 8th day after admission to ICU

  35. Barthel Index

    Time frame: 15th day after admission to ICU

  36. Modified Borg Test

    Time frame: During everyday she was admitted to the ICU

  37. Confusion Assessment Method for the intensive care unit (CAM-ICU)

    Time frame: During everyday she was admitted to the ICU

  38. Richmond Ajitation-Sedation Scale

    Time frame: During everyday she was admitted to the ICU

  39. Numeric Rating Scale

    Time frame: During everyday she was admitted to the ICU

Study contacts

Contact information is provided by the study sponsor or research team.

Arzu Erden Güner, PhD

CONTACT

[email protected]

+90 506 248 26 80

Sponsors and collaborators

Lead sponsor

Emre Şenocak

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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