Delirium Treatment With Acupuncture in Internal Medicine Departments: a Randomized Sham-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Time-to-first Remission of Delirium in the 7 Days of Evaluation
研究概览
简要总结
Delirium frequently occurs in hospitalized older people, and treatment options are limited. Acupuncture has been shown to reduce agitation in the setting of dementia. The investigators will test the hypothesis that it may also assist in treating delirium.
详细描述
This randomized-controlled trial aims to evaluate the efficacy of acupuncture integrated with standard care as compared to standard care only for the treatment of delirium in hospitalized older persons.
Patients aged 65 and older, hospitalized in the internal medicine departments of Bnai Zion Medical Center and diagnosed with delirium or subsyndromal delirium will be randomized to either true acupuncture with usual care, or usual care only. Daily treatments and outcomes' follow-up will be conducted up to one week from recruitment or until resolution of delirium or subsyndromal delirium for 48 hours. The primary outcome will be delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free.Side effects will be monitored daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized in internal medicine department
- •Aged over 65 years
- •Delirium or subsyndromal delirium within the last 48 hours
排除标准
- •Platelet count under 20x10^9/L
- •Encephalopathy explained by a cause other than delirium (acute stroke, alcohol, cirrhosis, etc.)
- •History of severe dementia
- •Communication barriers preventing delirium assessment
结局指标
主要结局
Time-to-first Remission of Delirium in the 7 Days of Evaluation
时间窗: At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7 of the study
Daily assessment of Confusion Assessment Method scale - a validated diagnostic tool addressing the four features of delirium (acute and fluctuating course, inattention, disorganized thinking and impaired level of consciousness). Definite delirium is defined as the first two features plus either one of the third or fourth, while subsyndromal delirium includes patients not meeting these diagnosis criteria but displaying two or more of these four features including the first one (acute and fluctuating course).
Number of Delirium-free Days During the 7 Days of Evaluation
时间窗: At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study
Number of delirium-free days, based on daily assessment of Confusion Assessment Method scale - a validated diagnostic tool addressing the four features of delirium (acute and fluctuating course, inattention, disorganized thinking and impaired level of consciousness). Definite delirium is defined as the first two features plus either one of the third or fourth, while subsyndromal delirium includes patients not meeting these diagnosis criteria but displaying two or more of these four features including the first one (acute and fluctuating course).
次要结局
- Visual Assessment Scale (VAS) for Pain(At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study)
- Number of Days in Which Antipsychotic Drugs Were Used(At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study)
- Sleep(At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study)
- Delirium Severity(Sum of CAM-S at day 2 + day 3 + day 4 + day 5 + day 6 + day 7 of the study)
- Delirium Complications(At baseline, day 2, day 3, day 4, day 5, day 6 and day 7 of the study)
- Mortality(During the 7-day intervention)
- Functional Status at Discharge(Through study completion, an average of 2-3 weeks)
- Length of Hospital Stay(Through study completion, an average of 2-3 weeks)