NCT06100029

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Chongqing Traditional Chinese Medicine Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Delirium in Old Age

Interventions

Type	Name	Description
DRUG	Lavender	The lavender aroma (L. angustifolia ssp. Angustifolia) is provided by Pranarom International, Ghislenghien, Belgium. Lavender aroma will be contained in a 10 ml glass bottle with a drop stopper and place the bottle within 20 cm of the patient's pillow so that the aroma can reach the patient. The entire course of treatment lasts 5 days.
BEHAVIORAL	A2F bundle	A: assess, prevent, and manage pain; B: both spontaneous awakening and breathing trials; C: choice of analgesia and sedation; D: delirium assessment, prevention, and management; E: early mobility and exercise; and F: family engagement/empowerment

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2023-10-25
• Last updated: 2024-05-30

Locations

1 site across 1 country: China