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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEmre Şenocak

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

  • Biopsychosocial-Based Multimodal Approach

    Procedure/Surgery

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Routine TreatmentActive comparator 1 intervention
Group B: ICU.DelibmaExperimental treatment 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Emre Şenocak

Lead sponsor

Karadeniz Technical University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: