The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol

Delirium in Old Age Clinical Trial

Official title: The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol for a Double Blind, Randomized, Placebo-controlled Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

• NCT number: NCT06100029
• Study type: Interventional
• Source: Chongqing Traditional Chinese Medicine Hospital
• Contact: Judan Tan
• Phone: +8618523837758
• Email: judantan@icloud.com
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: November 30, 2024