Determining the effect of lavender essential oil on the sleep quality of children with autism aged 6-12 years in Isfahan: A randomized controlled clinical trial
Design
A phase 3, randomized, double-blind, parallel-arm controlled clinical trial on 66 children with autism. Participants will be randomly assigned to 2 groups using block randomization with the blockrand package in R software.
Settings and conduct
Lavender essential oil and normal saline, prepared in coded vials by a research assistant according to a randomization list from the statistical consultant, will be given to parents to blind the researcher and the statistical consultant. The research assistant will also provide usage instructions, which include placing 3 drops of the solution on a gauze pad and attaching it to the child's collar every night before sleep for 14 nights.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
province, during the academic year 2025؛ Consent to participate in the study؛ Willingness to cooperate؛ Sleep quality score greater than 41 on the CSHQ؛ No history of rhinitis, allergies, or respiratory problems
Exclusion Criteria:
Lack of access to patients after the start of the intervention؛ Withdrawal of consent at any stage of the study؛ Incomplete questionnaire؛ Lack of cooperation؛ Development of urticaria (hives)؛ Occurrence of an unforeseen crisis or event؛ Presence of another acute or chronic disorder or disease concurrent with autism
Intervention groups
Children with autism will be randomly assigned to two groups using block randomization: a group receiving lavender essential oil and a control group. They will receive three drops via aromatherapy every night before sleep for fourteen nights.
Main outcome variables
Addressing sleep disturbances, which, if effective, would improve quality of life and sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240828062891N1
Registration date:2025-06-08, 1404/03/18
Registration timing:prospective
Last update:2025-06-08, 1404/03/18
Update count:0
Registration date
2025-06-08, 1404/03/18
Registrant information
Name
Zahra Roshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3343 6059
Email address
zahraroshani779@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2026-03-19, 1404/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender essential oil on the sleep quality of children with autism aged 6-12 years: a randomized controlled clinical trial study
Public title
The effect of lavender essential oil on the sleep quality of children with autism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All children aged 6-12 years with autism in Dast haye Mehraban and Mehr Afarin schools, Isfahan province, during the academic year 2025.
Consent to participate in the study.
Cooperation throughout the study.
Sleep quality score greater than 41 on the CSHQ (Children's Sleep Habits Questionnaire).
No history of rhinitis, allergies, or respiratory problems.
Exclusion criteria:
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were enrolled in the study based on the inclusion and exclusion criteria via convenience sampling until the required sample size was reached. Subsequently, to standardize the distribution of confounding factors (gender and age), stratified blocks were created based on gender (female/male) and age groups (6-9 years and 9-12 years). Using the blockrand package in R software, the study participants will be randomly assigned to 2 groups using block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Lavender essential oil procured from Giahe Kala Company and normal saline will be prepared by the research assistant in coded dark vials based on a randomized block list generated by the statistical consultant and will be delivered to the parents.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Second Mehr mihan alley, Mehr mihan street, Bozorgmehr street
City
Khorramabad
Province
Lorestan
Postal code
6819681369
Approval date
2025-01-28, 1403/11/09
Ethics committee reference number
IR.LUMS.REC.1403.445
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Sleep quality score on the Children's Sleep Habits Questionnaire.
Timepoint
Sleep quality score at baseline (before the start of the intervention) and 14 days after the start of aromatherapy with lavender essential oil.
Method of measurement
Children's Sleep Habits Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive lavender essential oil, prepared by Giah Kala Company. This essential oil will be coded and packaged in dark glass bottles by the research assistant. The bottles will be distributed to parents based on a randomized block list prepared by the statistical consultant.The research assistant will also provide training to the parents on the method of use. Parents will be instructed to apply three drops from the provided bottle onto a piece of gauze every night for fourteen consecutive nights, just before their child goes to sleep. This gauze will then be attached to the child's collar so the child can inhale the aroma. Upon waking, the gauze should be removed from the collar and discarded.For any questions or concerns, parents will be provided with a contact number to reach the research assistant. Throughout the two-week intervention period, the research assistant will also conduct follow-up phone calls to monitor the correct application of the aromatherapy.
Category
Rehabilitation
2
Description
Control group:The control group will receive normal saline. This saline will be coded and packaged in dark glass bottles by the research assistant. The bottles will be distributed to parents based on a randomized block list prepared by the statistical consultant.The research assistant will provide training to the parents on the method of use. Parents will be instructed to apply three drops from the provided bottle onto a piece of gauze every night for fourteen consecutive nights, just before their child goes to sleep. This gauze will then be attached to the child's collar so the child can inhale it. Upon waking, the gauze should be removed from the collar and discarded.For any questions or concerns, parents will be provided with a contact number to reach the research assistant. Throughout the two-week control period, the research assistant will also conduct follow-up phone calls to monitor the correct application of the procedure.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Afarin Educational Complex for Children with Autism