NCT06100029

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

October 17, 2023

Last Update Submit

May 28, 2024

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Severity of delirium

    Through study completion, an average of 1 year (November 31, 2023-November 31, 2024)

  • Duration of delirium

    Through study completion, an average of 1 year (November 31, 2023-November 31, 2024).

Study Arms (2)

Intervention group

EXPERIMENTAL

lavender aromatherapy

Drug: LavenderBehavioral: A2F bundle

Control group

PLACEBO COMPARATOR

distilled water

Behavioral: A2F bundle

Interventions

LavenderDRUG

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.

Also known as: aromatherapy
Intervention group
A2F bundleBEHAVIORAL

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

Also known as: ABCDEF bundle
Control groupIntervention group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing traditional Chinese medicine hospital

Chongqing, China

RECRUITING

MeSH Terms

Interventions

lavender oilAromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dongsheng Ren

    Chongqing Traditional Chinese Medicine Hospital

    STUDY DIRECTOR

Central Study Contacts

Judan Tan

CONTACT

+8618523837758judantan@icloud.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 25, 2023

Study Start

November 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)