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IRCT20240828062891N1 IRCT 2025-06-08 Khoram-Abad University of Medical Sciences The effect of lavender essential oil on the sleep quality of children with autism The effect of lavender essential oil on the sleep quality of children with autism aged 6-12 years: a randomized controlled clinical trial study 2025-09-22 anticipated 66 Complete https://irct.ir/trial/83162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Autism. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Given that the research work has not yet started, the status of the paper is unclear, and I will decide in the future.
public Zahra Roshani
Second Mehr mihan alley, Mehr mihan street, Bozorgmehr street
Khorramabad Iran (Islamic Republic of) 6819681369 +98 66 3343 6059 Zahraroshani779@gmail.com Khoram-Abad University of Medical Sciences scientific Zahra Roshani
Second Mehr mihan alley, Mehr mihan street, Bozorgmehr street
Khorramabad Iran (Islamic Republic of) 6819681369 +98 66 3343 6059 Zahraroshani779@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 6 years 12 years Both F84.0 Autistic disorder Rehabilitation Rehabilitation 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. 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. 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. Khoram-Abad University of Medical Sciences Approved 2025-01-28 Ethics committee of Lorestan University of Medical Sciences Second Mehr mihan alley, Mehr mihan street, Bozorgmehr street Khorramabad Lorestan Iran (Islamic Republic of)