RecruitingNot ApplicableNCT06100029

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


Sponsor

Chongqing Traditional Chinese Medicine Hospital

Enrollment

68 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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.

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Interventions

DRUGLavender

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.

BEHAVIORALA2F 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(1)

Chongqing traditional Chinese medicine hospital

Chongqing, China

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NCT06100029


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