Determination of the inhalation effect of lavender essential oil on the level of sedation in children hospitalized in the intensive care unit (ICU)
Design
"A phase 1, double-blind, randomized, parallel-group, controlled clinical trial on 70 patients. The SPSS software block function was used for randomization.
Settings and conduct
In the placebo group, in addition to routine care, 5 drops of distilled water are inhaled for 30 minutes every eight hours. Similarly, the intervention group inhales 5 drops of lavender extract for 30 minutes every eight hours. Then, as per the routine of the intensive care unit, agitation scores will be assessed for all studied patients in each shift (every six hours) by the respected ICU nurse using the Richmond Agitation Sedation Scale (RASS). Subsequently, the amount of sedation medications used, as well as the mean Richmond sedation score over the 24 hours following the intervention, will be measured in both groups according to the guideline
Shahid Bahonar hospital of kerman
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 12 to 18 years
GCS greater than or equal to 8
extubated
Exclusion Criteria:
Intubation
Patient death
changes in hemodynamic
Intervention groups
Control group: In this group, in addition to routine ward care, a placebo (distilled water) is used. Five drops of distilled water are applied to gauze, which is then attached to the patient’s collar. The patient inhales from it for 30 minutes.
Intervention group : In this group, in addition to routine ward care, lavender essential oil from Royaye Salamat Company is also used. Five drops of lavender extract from Royaye Salamat Company at a concentration of 2% are applied to gauze, which is then attached to the patient's collar at a distance of 10 centimeters. The patient inhales it for 30 minutes."
Main outcome variables
RASS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101220005426N15
Registration date:2026-05-14, 1405/02/24
Registration timing:prospective
Last update:2026-05-14, 1405/02/24
Update count:0
Registration date
2026-05-14, 1405/02/24
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-31, 1405/03/10
Expected recruitment end date
2026-12-30, 1405/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the inhalation effect of lavender essential oil on sedation levels in children hospitalized in the intensive care unit (ICU)
Public title
Investigating the Effect of Lavender on the Level of Sedation in Hospitalized Children in the ICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 12 to 18 years
GCS greater than or equal to 8
Admitted to intensive care units (ICU)
Patient extubated at the time of study entry
Hemodynamic stability
No known history of hypersensitivity to lavender or other aromatic herbal compounds
No history of chronic respiratory diseases
No clinical signs or diagnosis of active pulmonary aspiration
No primary or secondary immunodeficiency disorders
Having a normal sense of smell
Written informed consent from the patient’s parent or legal guardian
Exclusion criteria:
Patient intubation
Transfer of the patient to other units
Patient death
Sudden and significant changes in hemodynamic status
Occurrence of any side effects
Age
From 12 years old to 18 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the patients, a block randomization method with block sizes of 4, 6, and 8 (using SPSS software) will be used to assign individuals to the two groups. This method will also ensure concealment of allocation. In this approach, each individual will be assigned a unique code, which will be attached to the medication packages, thereby also facilitating the blinding process. Patients will be placed into either the intervention group (35 patients) or the placebo group (35 patients).
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study in which people will be divided into two control and intervention groups. Participants and data analyzers will not be not aware of the allocation of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Kerman University of Medical Sciences
Street address
Vice chancellor for research Kerman university of medical science, Jahad street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2026-02-01, 1404/11/12
Ethics committee reference number
IR.KMU.AH.REC.1404.235
Health conditions studied
1
Description of health condition studied
Agitation rate
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Aromatherapy
Timepoint
At the beginning and end of the intervention
Method of measurement
Charted information
2
Description
RASS (Richmond Agitation-Sedation Scale) SCORE
Timepoint
At 0, 6, 12, 18, and 24 hours after the start of the intervention
Method of measurement
RASS table
Secondary outcomes
1
Description
BMI
Timepoint
At the beginning of the intervention
Method of measurement
File information
2
Description
Age
Timepoint
At the beginning of the intervention
Method of measurement
File information
3
Description
Gender
Timepoint
At the beginning of the intervention
Method of measurement
File information
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the routine care provided in the intensive care unit (for controlling anxiety and agitation, which includes the use of sedatives such as benzodiazepines—e.g., midazolam at an initial dose of 0.1 mg/kg and a maintenance dose of 0.05 mg/kg/h, or lorazepam at an initial dose of 0.05 mg/kg—and haloperidol at an initial dose of 0.04 mg/kg and a maintenance dose of 0.05 mg/kg/day if agitation occurs, based on physician’s orders), lavender oil is also used to manage anxiety. The method involves soaking gauze with 5 drops of lavender extract (lavender essential oil from Royaye Salamat Company) at a 2% concentration, with a final linalool concentration of 0.5%. The gauze is placed 10 cm from the patient’s collar every 8 hours, and the patient inhales the vapor for 30 minutes. This intervention will be repeated three times per patient and will last a total of 24 hours.
Category
Other
2
Description
Control group: In addition to routine intensive care unit (ICU) care (to manage anxiety and agitation, including the use of sedative benzodiazepines such as midazolam at an initial dose of 0.1 mg/kg and maintenance dose of 0.05 mg/kg/h, or lorazepam at an initial dose of 0.05 mg/kg, and haloperidol at an initial dose of 0.04 mg/kg and maintenance dose of 0.05 mg/kg/day if agitation occurs, as per physician’s order), patients will receive a placebo (distilled water) to control anxiety. The method is as follows: 5 drops of distilled water are applied to gauze, which is then attached to the patient’s collar at a distance of 10 cm, every eight hours. The patient inhales from it for 30 minutes. This intervention will be repeated three times per patient and will last a total of 24 hours.