Randomized Clinical Trial to Evaluate the Effect of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients
试验速览
- 阶段
- 不适用
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- Incident cases of delirium.
研究概览
简要总结
This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly in-patients. Half of patients will receive earplugs and eyemask for use during the night and information about orientation to time and space every night, while the other half will receive only the time and space orientations.
详细描述
Delirium is an acute neuropsychiatric syndrome usually associated with a general medical condition. Its prevalence is high among hospitalized elderly patients and is generally underdiagnosed. Delirium is associated with prolonged hospitalization, increased mortality, institutionalization, falls, cognitive and functional decline and also with higher economic costs. The etiology of delirium is multifactorial, including excessive sensorial stimulation and disruption of the sleep-wake cycle as triggering factors.
The aim of this study is evaluate the effect of earplugs and eyemask for delirium prevention among elderly in-patients of a brazilian university hospital. This will be a partially blinded clinical trial, in wich both control and intervention group will receive information about orientation to time and space every evening, and intervention group will also receive earplugs and eyemask for use during the night. The primary outcome will be the occurrence of delirium.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patients, expected to stay for at least 24 hours.
- •Understand and consent in participating in the study and sign the consent form.
- •60 years of age, or older.
- •Visual and auditory acuity sufficient to perform cognitive tests.
排除标准
- •Diagnosis of delirium in the selection visit.
- •Glasgow Coma Scale less than 15 in the selection visit.
- •PRISMA-7 ≤3 patient will be excluded.
结局指标
主要结局
Incident cases of delirium.
时间窗: Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study.
The short version of the Confusion Assessment Method (Short-CAM) will be used.
次要结局
- Sleep quality(Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.)
- Safety of the intervention.(Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.)
- Acceptance, confort and adherence to the intervention.(After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study.)
- Use of psychotropic drugs.(Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study.)
- Time of hospital stay.(Until hospital discharge, up to 6 months from inclusion in the study.)
- Evaluation of the sleep-wake cycle.(Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.)
- Urinary 6-sulfatoxymelatonin levels.(48 hours after admission (first urine of the day))