The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Delirium incidence
研究概览
简要总结
Delirium is highly associated with adverse clinical outcomes of intensive care unit (ICU) patients, including increased cognitive impairment, duration of intubation, ICU length of stay, mortality, physical dependence, and health care costs. This randomised controlled study will firstly develop a family-supported sensory stimulation package based on the literature review as well as the findings of the cross-sectional survey and the in-depth interview. The intervention effects than will be evaluated using outcomes including delirium incidence, delirium duration, delirium severity, ICU patients' consciousness and cognitive function as well as family members' satisfaction and anxiety. This study is expected to provide evidence of the effectiveness of family-supported sensory stimulation on preventing delirium among ICU patients.
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)
盲法说明
The outcome assessors will be blinded to the group allocation and will not be involved in data analysis and results reporting.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •the first time admitted to ICU
- •a Richmond Agitation-Sedation Scale (RASS) score ≥-3
排除标准
- •diagnosed with stroke, dementia, delirium or acute psychiatric illness at admission
- •diagnosed with end-stage of cancer
- •severe hearing impairment and cannot be corrected by hearing aids
- •admitted to ICU with radiative material.
研究组 & 干预措施
Sensory stimulation
Participants allocated to the intervention group will receive a model-based sensory stimulation intervention, which is aimed at providing visual and auditory stimulation to ICU patients with additional support from family caregivers.
干预措施: Sensory stimulation (Other)
Usual care
Participants in the control group will receive usual care routine that they are receiving or planning to receive. The registered ICU nurses will provide the same nursing care as previously, including but not limiting to the use of sedation, analgesia, spontaneous breathing trial, indwelling catheter, feeding, and bowel care.
结局指标
主要结局
Delirium incidence
时间窗: Through study completion, an average of seven days
Delirium incidence means the number of patients who are delirious.
First occurrence of delirium
时间窗: Through study completion, an average of seven days
First occurrence of delirium was defined as the first time that patients was delirium positive through CAM-ICU. The time to have the first occurrence of delirium was calculated from patients' admission to ICU to the first positive result of delirium assessment.
Delirium duration
时间窗: Through study completion, an average of seven days
The delirium duration will be calculated when the patient is first considered to have delirium to the last time that patient is not supposed to have delirium based on CAM-ICU.
Delirium severity
时间窗: Through study completion, an average of seven days
CAM-ICU-7 scores are further categorised as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
次要结局
- Post-traumatic stress disorder (PTSD)(Through study completion, an average of seven days)
- Depressive symptoms(At one month upon patients' admission to ICU)
- Family satisfaction(Through study completion, an average of seven days)
- Level of anxiety(Through study completion, an average of seven days)
- ICU memory(Through study completion, an average of seven days)
- Depressive symptoms(Through study completion, an average of seven days)
研究者
Liang Surui
Principal Investigator
Chinese University of Hong Kong