The effect of lavender essential oil for delirium in elderly ICU patients: Study protocol for a double blind, randomized, placebo-controlled trial

I ntroduction: 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, 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 prevalence rate and shorten the duration of delirium in ICU patients. M ethods and analysis: This trial was designed to be a randomized, single-center, double-blind, placebo-controlled trial. A total of 68 elderly patients from ICU 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 multi-component approach including pain and delirium management, breathing trial practice, family engagement and so on, to prevent delirium. The intervention group will additionally receive aromatherapy lasting for five days. The primary endpoints are 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 to measure the prevalence of delirium and analyses of variance (ANOVAs) or repeated-measures ANOVAs and Wilcoxon rank-sum tests to analyze the observation results. D iscussion: The incidence of delirium in the ICU is high, which significantly impacts the short-term therapeutic effects and long-term quality of life for critically ill patients. This study we proposed will be a randomized, double-blind, placebo-controlled trial to assess the efficacy of aromatherapy in preventing delirium and the results of this study will provide deeper insights into the effectiveness of non-pharmacological interventions for delirium patients. If the experimental results are promising, further research can be conducted on the specific impact pathways and mechanisms of this treatment among elderly patients with delirium. E thics and dissemination: Ethical approval was obtained from the Ethics Committee of the Chongqing Traditional Chinese Medicine hospital (Ethical Review Number:2023-ky-47). The results of this study will be published in a peer-reviewed journal. The study sponsor does not have any role in study-related activities or in the final publication of the study. T rial registration: Chinese Clinical Trial Registry. Registration Number:ChiCTR2400088130. Registration Date:2024-8-12.