Effects of Interactive Hand-grip Strength Game in Critically Illness Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline on Post-traumatic stress disorder(PTSD)
研究概览
简要总结
Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigators aim to design an interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care.
详细描述
Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigaters aim to design a interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care. This will be a two-arm, parallel randomized controlled trial which randomly assign patients into the game group and usual care group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 20 years
- •Having clear consciousness
- •Independently able to mobilize to complete the intervention and communicate in Chinese
- •Richmond Agitation-Sedation Scale (RASS) 24 between +1 to -1 if using sedatives
排除标准
- •Suspect neurological deficits
- •Neuromuscular disease
- •Orthopedic injuries with contraindications to mobilize
结局指标
主要结局
Change from baseline on Post-traumatic stress disorder(PTSD)
时间窗: The 1st, and 3th day of ICU.
The PTSD is assessed by Post-traumatic Stress Syndrome 10-question inventory (PTSS-10).The measurement involved 10 items and each item is rated using a seven-point Likert scale (1 "never" to 7 "always").
Change from baseline on stress
时间窗: The 1 day of enrollment, and 3th day of ICU.
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score\>14 is associated with anxiety. The higher score means more severe stress.
Change from baseline on depression
时间窗: The 1 day of enrollment, and 3th day of ICU.
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score\>9 is associated with depression. The higher score means more severe depression.
Change of Delirium incidence
时间窗: Every 8 hours during ICU stay up to 3 days
The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)
Change from baseline on anxiety
时间窗: The 1 day of enrollment, and 3th day of ICU.
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 of anxiety has 7 items of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score\>7 is associated with anxiety. The higher score means more severe anxiety.
次要结局
- ICU acquired weakness(The 1st day of ICU.)
- Change from baseline on sleep quality(The 1st, and 3th day of ICU.)
- Changes of Pain(Everyday during ICU stay up to 3 days)
研究者
Hsiao-Yean Chiu
Associated professor
Taipei Medical University