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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100029
• Other study ID #: ChongqingTCMH
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Chongqing Traditional Chinese Medicine Hospital
• Contact: Judan Tan
• Phone: +8618523837758
• Email: judantan[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

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

Locations

Country	Name	City	State
China	Chongqing traditional Chinese medicine hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Traditional Chinese Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prevalence of delirium	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.	Through study completion, an average of 1 year (November 31, 2023-November 31, 2024)
Secondary	Severity of delirium	Throughout the study, the Confusion Assessment Method-Severity scale will be administered in each included patient. The total score of the Confusion Assessment Method-Severity scale can vary between 0 and 7, where 7 indicates the most severe condition.	Through study completion, an average of 1 year (November 31, 2023-November 31, 2024)
Secondary	Duration of delirium	Once delirium is diagnosed, the investigators will record its duration of the patient tests positive for the Confusion Assessment Method for the ICU (CAM-ICU)	Through study completion, an average of 1 year (November 31, 2023-November 31, 2024).