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Subarachnoid Haemorrhagic StrokeNCT07249619

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

A study testing Routine Therapy (Medical, environmental accodamation, face-to-face commucation) and Biopsychosocial-Based Multimodal Approach in people with Subarachnoid Haemorrhagic Stroke, run by Emre Şenocak at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Subarachnoid Haemorrhagic Stroke
What is being tested?
Routine Therapy (Medical, environmental accodamation, face-to-face commucation) and Biopsychosocial-Based Multimodal Approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Jan 2026to 2 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arzu Erden Güner, PhD contact

+90 506 248 26 80

arzuerden@ktu.edu.tr

Turkey (Türkiye)1 site

  • Karadeniz Technical University, Farabi Hospital

    Trabzon

    Arzu Erden Güner, PhD, +90 506 248 26 80, arzuerden@ktu.edu.tr

Other trials in Turkey (Türkiye)

About this study

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)

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.

Being tested
Routine Therapy (Medical, environmental accodamation, face-to-face commucation), Biopsychosocial-Based Multimodal Approach
Keywords
Body Awareness Therapy, Communication, Delirium
Medical subject headings
Communication, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 ApproachProcedure or surgery

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

Study groups in NCT07249619
Study groupRoleWhat they receive
Routine TreatmentActive comparatorA treatment program will be implemented in line with the recommendations of international guidelines for the treatment of delirium.
Receives: Other: Routine Therapy (Medical, environmental accodamation, face-to-face commucation)
ICU.DelibmaExperimentalIn 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.
Receives: Other: Routine Therapy (Medical, environmental accodamation, face-to-face commucation); Procedure: Biopsychosocial-Based Multimodal Approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Charlson Comorbidity Index

    Measured: Baseline

  2. Charlson Comorbidity Index

    Measured: 8th day after admission to ICU

  3. Charlson Comorbidity Index

    Measured: 15th day after admission to ICU

  4. Mini-Mental State Examination Test

    Measured: Baseline

  5. APACHE II Score

    Measured: Baseline

  6. APACHE II Score

    Measured: 8th day after admission to ICU

  7. APACHE II Score

    Measured: 15th day after admission to ICU

  8. SOFA Score

    Measured: Baseline

  9. SOFA Score

    Measured: 8th day after admission to ICU

  10. SOFA Score

    Measured: 15th day after admission to ICU

  11. Glaskow Coma Score

    Measured: During everyday she was admitted to the ICU

  12. Modified Rankin Scale

    Measured: Baseline

  13. Modified Rankin Scale

    Measured: 8th day after admission to ICU

  14. Modified Rankin Scale

    Measured: 15th day after admission to ICU

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

    Measured: Baseline

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

    Measured: 8th day after admission to ICU

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

    Measured: 15th day after admission to ICU

  18. Medical Research Council Muscle Strenght

    Measured: Baseline

  19. Medical Research Council Muscle Strenght

    Measured: 8th day after admission to ICU

  20. Medical Research Council Muscle Strenght

    Measured: 15th day after admission to ICU

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

    Measured: Baseline

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

    Measured: 8th day after admission to ICU

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

    Measured: 15th day after admission to ICU

  24. Hospital Anxiety and Depression Scale

    Measured: Baseline

  25. Hospital Anxiety and Depression Scale

    Measured: 8th day after admission to ICU

  26. Hospital Anxiety and Depression Scale

    Measured: 15th day after admission to ICU

  27. Montreal Cognitive Assessment

    Measured: Baseline

  28. Montreal Cognitive Assessment

    Measured: 8th day after admission to ICU

  29. Montreal Cognitive Assessment

    Measured: 15th day after admission to ICU

  30. Nothingham Health Profile

    Measured: Baseline

  31. Nothingham Health Profile

    Measured: 8th day after admission to ICU

  32. Nothingham Health Profile

    Measured: 15th day after admission to ICU

  33. Barthel Index

    Measured: Baseline

  34. Barthel Index

    Measured: 8th day after admission to ICU

  35. Barthel Index

    Measured: 15th day after admission to ICU

  36. Modified Borg Test

    Measured: During everyday she was admitted to the ICU

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

    Measured: During everyday she was admitted to the ICU

  38. Richmond Ajitation-Sedation Scale

    Measured: During everyday she was admitted to the ICU

  39. Numeric Rating Scale

    Measured: During everyday she was admitted to the ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start2 Jan 2026 (estimated)
  3. Primary completion2 Jan 2028 (estimated)
  4. Study completion2 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249619
Sponsor's protocol ID
2024/6
Status last verified
Oct 2025
First submitted
18 Nov 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Routine Therapy (Medical, environmental accodamation, face-to-face commucation) and Biopsychosocial-Based Multimodal Approach in people with Subarachnoid Haemorrhagic Stroke, run by Emre Şenocak at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arzu Erden Güner, PhD (+90 506 248 26 80, arzuerden@ktu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Charlson Comorbidity Index (time frame: Baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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