Effect of Auditory Stimulation by Family Voices in Preventing Delirium Among Sedative Patients in Emergency Intensive Care Units ：A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- incidence of delirium
研究概览
简要总结
Delirium is an acute cerebral dysfunction syndrome characterized by acute fluctuating changes in consciousness, cognitive dysfunction, and disorientation. It's especially common in critically ill patients of emergency intensive care units and seriously threatens the survival and prognosis of patients and causes heavy economic burdens to the family, society, and medical service system. Impaired verbal communication, unfamiliar medical personnel, physical restraint, spatial-temporal disorientation, mechanical ventilation and sedation medication use can lead to a lack of adequate sensory stimulation and a high risk of delirium. Acoustic stimulation as a non-invasive non-pharmacological intervention can provide some sensory stimulation as a surrogate for critically ill patients. This research designs the content scripts from the needs of ICU patients and families for sound stimulation. The goal of this randomized controlled study is to test the effect of auditory stimulation by family voices in preventing delirium among sedative patients in emergency Intensive care units.
详细描述
Patients are separated from their families and society under the closed management of the intensive care unit, the use of sedative drugs, mechanical ventilation, impaired verbal communication, physical restraint, environmental noise, and prolonged light exposure, which lead to a lack of adequate sensory stimulation, causing sensory deprivation in patients to some extent. In turn, sensory deprivation may cause multisensory perceptual confusion and hallucinations, affecting patients' orientation and thinking and triggering delirium, so providing appropriate sensory stimulation to critically ill patients may help to improve patients' orientation and attention, correct patients' thinking confusion and prevent delirium, and in clinical practice, sensory stimulation is considered as an important part of multicomponent delirium prevention programs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •transferred to the EICU from emergency admission
- •no other history of emergency, surgery, or ICU admission history within 30 days
- •no delirium in the first screening of Emergency Intensive Care Unit(EICU) admission
- •with an expected length of stay in EICU longer than 24h and use of sedation medication
排除标准
- •Presence of hearing impairment, severe dementia, psychiatric disorder, or other severe brain dysfunction that hinders delirium assessment
- •persistent coma or deep sedation (RASS score of -4 to -5)
- •patients without a family member who can cooperate with the recording
- •external ear disease or surgery that hinders earphone wearing
结局指标
主要结局
incidence of delirium
时间窗: up to 5 days
use the Confusion Assessment Method for the ICU (CAM-ICU)
次要结局
- delirium severity(up to 5 days)
- delirium subtype(up to 5 days)
- time to first delirium(up to 5 days)
- delirium duration(up to 5 days)
- delirium-free days(up to 5 days)
- family anxiety levels(up to 5 days)
- family depression levels(up to 5 days)
- Duration of mechanical ventilation(up to 5 days)