Skip to content

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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07249619
Enrollment
34
Registered
2025-11-25
Start date
2026-01-02
Completion date
2028-01-02
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Haemorrhagic Stroke

Keywords

Body Awareness Therapy, Communication, Delirium

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.

Interventions

OTHERRoutine 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.

PROCEDUREBiopsychosocial-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.

Sponsors

Emre Şenocak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
Numeric Rating ScaleDuring everyday she was admitted to the ICU
Charlson Comorbidity IndexBaseline
Mini-Mental State Examination TestBaseline
APACHE II ScoreBaseline
SOFA ScoreBaseline
Glaskow Coma ScoreDuring everyday she was admitted to the ICU
Modified Rankin ScaleBaseline
Simple five-item questionnaire (SARC-F)Baseline
Medical Research Council Muscle StrenghtBaseline
Physical Function in Intensive Care Test (PFIT-s)Baseline
Hospital Anxiety and Depression ScaleBaseline
Montreal Cognitive AssessmentBaseline
Nothingham Health ProfileBaseline
Barthel IndexBaseline
Modified Borg TestDuring 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 ScaleDuring everyday she was admitted to the ICU

Countries

Turkey (Türkiye)

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026