A Biopsychosocial-Based Multimodal Approach to Reducing the Risk of Delirium in Patients With Subarachnoid Hemorrhage in the Intensive Care Unit (ICU.Delibma)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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;
研究组 & 干预措施
Routine Treatment
A treatment program will be implemented in line with the recommendations of international guidelines for the treatment of delirium.
干预措施: Routine Therapy (Medical, environmental accodamation, face-to-face commucation) (Other)
ICU.Delibma
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.
干预措施: Routine Therapy (Medical, environmental accodamation, face-to-face commucation) (Other)
ICU.Delibma
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.
干预措施: Biopsychosocial-Based Multimodal Approach (Procedure)
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: 15th day after admission to ICU
Nothingham Health Profile
时间窗: 15th day after admission to ICU
Barthel Index
时间窗: 15th day after admission to ICU
Modified Borg Test
时间窗: During everyday she was admitted to the ICU
Confusion Assessment Method for the intensive care unit (CAM-ICU)
时间窗: During everyday she was admitted to the ICU
Richmond Ajitation-Sedation Scale
时间窗: During everyday she was admitted to the ICU
Numeric Rating Scale
时间窗: During everyday she was admitted to the ICU
Physical Function in Intensive Care Test (PFIT-s)
时间窗: 15th day after admission to ICU
Hospital Anxiety and Depression Scale
时间窗: 15th day after admission to ICU
Charlson Comorbidity Index
时间窗: 15th day after admission to ICU
Mini-Mental State Examination Test
时间窗: Baseline
APACHE II Score
时间窗: 15th day after admission to ICU
SOFA Score
时间窗: 15th day after admission to ICU
Glaskow Coma Score
时间窗: During everyday she was admitted to the ICU
Modified Rankin Scale
时间窗: 15th day after admission to ICU
Simple five-item questionnaire (SARC-F)
时间窗: 15th day after admission to ICU
Medical Research Council Muscle Strenght
时间窗: 15th day after admission to ICU
Charlson Comorbidity Index
时间窗: Baseline
Charlson Comorbidity Index
时间窗: 8th day after admission to ICU
APACHE II Score
时间窗: Baseline
APACHE II Score
时间窗: 8th day after admission to ICU
SOFA Score
时间窗: Baseline
SOFA Score
时间窗: 8th day after admission to ICU
Modified Rankin Scale
时间窗: Baseline
Modified Rankin Scale
时间窗: 8th day after admission to ICU
Simple five-item questionnaire (SARC-F)
时间窗: Baseline
Simple five-item questionnaire (SARC-F)
时间窗: 8th day after admission to ICU
Medical Research Council Muscle Strenght
时间窗: Baseline
Medical Research Council Muscle Strenght
时间窗: 8th day after admission to ICU
Physical Function in Intensive Care Test (PFIT-s)
时间窗: Baseline
Physical Function in Intensive Care Test (PFIT-s)
时间窗: 8th day after admission to ICU
Hospital Anxiety and Depression Scale
时间窗: Baseline
Hospital Anxiety and Depression Scale
时间窗: 8th day after admission to ICU
Montreal Cognitive Assessment
时间窗: Baseline
Montreal Cognitive Assessment
时间窗: 8th day after admission to ICU
Nothingham Health Profile
时间窗: Baseline
Nothingham Health Profile
时间窗: 8th day after admission to ICU
Barthel Index
时间窗: Baseline
Barthel Index
时间窗: 8th day after admission to ICU
Nothingham Health Profile
时间窗: 15th day after admission to ICU
Barthel Index
时间窗: 15th day after admission to ICU
Hospital Anxiety and Depression Scale
时间窗: 15th day after admission to ICU
Simple five-item questionnaire (SARC-F)
时间窗: 15th day after admission to ICU
Medical Research Council Muscle Strenght
时间窗: 15th day after admission to ICU
Physical Function in Intensive Care Test (PFIT-s)
时间窗: 15th day after admission to ICU
Charlson Comorbidity Index
时间窗: 15th day after admission to ICU
Mini-Mental State Examination Test
时间窗: Baseline
APACHE II Score
时间窗: 15th day after admission to ICU
SOFA Score
时间窗: 15th day after admission to ICU
Glaskow Coma Score
时间窗: During everyday she was admitted to the ICU
Modified Rankin Scale
时间窗: 15th day after admission to ICU
Montreal Cognitive Assessment
时间窗: 15th day after admission to ICU
Modified Borg Test
时间窗: During everyday she was admitted to the ICU
Confusion Assessment Method for the intensive care unit (CAM-ICU)
时间窗: During everyday she was admitted to the ICU
Richmond Ajitation-Sedation Scale
时间窗: During everyday she was admitted to the ICU
Numeric Rating Scale
时间窗: During everyday she was admitted to the ICU
次要结局
未报告次要终点
研究者
Emre Şenocak
Assoc. Prof. Dr.
Karadeniz Technical University