The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol for a Double Blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the prevalence of delirium
研究概览
简要总结
Elderly critically ill patients in the intensive care unit (ICU) are at risk of delirium, which is primarily characterized by acute consciousness impairment and perceptual, cognitive, and memory impairment, resulting in excess death, care expenditures, and acquired dementia, depression and anxiety, which severely affect the prognosis of critically ill patients. However, there are currently no effective pharmacological strategies for preventing delirium. Inhalation aromatherapy has been proven to benefits the sleep disorder, anxiety or depression and lavender oil is one of the most used essential oils. Therefore, we hypothesized that the use of lavender would reduce the incidence rate of delirium in ICU patients.
详细描述
This trial was designed to be a randomized, single-center, double-blind, placebo-controlled trial. A total of 68 elderly patients from two ICUs will be randomly allocated at a 1:1 ratio to the intervention group or the control group. Both groups will receive the ABCDEF (A2F) bundle strategy recommended by guidelines, a multicomponent approach including pain and delirium management, breathing trial practice, analgesic and sedation usage control, family engagement and so on, to prevent delirium. The intervention group will additionally receive aromatherapy lasting for five days. The primary outcome is the prevalence of delirium. Secondary outcomes include the severity and duration of delirium, the length of ICU stay, the duration of physical restraint, the duration of analgesic and sedative medication and the 28-day mortality rate. We will use the CAM-ICU and CAM-S to measure the prevalence and severity of delirium, and analyses of variance (ANOVAs) or repeated-measures ANOVAs and Wilcoxon rank-sum tests to analyze the observation results.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients aged between 60 and 90 years old
- •Had an expected total ICU length of stay (LOS) of 72 hours or more
- •Admitted to the ICU within 48 hours before screening
- •Signed the informed consent form.
排除标准
- •Incapacitation preventing the assessment of delirium (i.e., coma, sedation, or active seizures)
- •History of psychiatric disorders, dementia, Parkinson's disease, use of antipsychotic drugs, or alcohol dependence
- •History of traumatic brain injury or brain infection
- •Diagnosis of delirium prior to intervention initiation
- •Allergies to medications used in the protocol or current participation in other drug studies
- •Inability to communicate in Chinese or English
- •Expected to be discharged or deceased within 72 hours of admission.
研究组 & 干预措施
Intervention group
lavender aromatherapy
干预措施: Lavender (Drug)
Control group
distilled water
干预措施: A2F bundle (Behavioral)
Intervention group
lavender aromatherapy
干预措施: A2F bundle (Behavioral)
结局指标
主要结局
the prevalence of delirium
时间窗: Through study completion, an average of 1 year (November 31, 2023-November 31, 2024)
Assessment will be performed during the study period for all enrolled participants in a timely manner using the Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU, a 2-minute assessment tool, has proven to be quick, valid, and reliable for the diagnosis of delirium in the ICU, making it beneficial for use in both clinical and research contexts.
次要结局
- Severity of delirium(Through study completion, an average of 1 year (November 31, 2023-November 31, 2024))
- Duration of delirium(Through study completion, an average of 1 year (November 31, 2023-November 31, 2024).)