The Effect of Aroma on Anxiety Among Children With Autism.

Not Applicable

Withdrawn

• Conditions: Anxiety; Autism Spectrum Disorder
• Interventions: Other: Control Blend; Other: Test Essential Oil Blend; Other: Active Essential Oil Blend

• Registration Number: NCT03489811
• Lead Sponsor: Franklin Health Research

Brief Summary

This study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.

Detailed Description

Essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder.

The essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. The oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils.

Anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. Parents complete this data online, allowing them to participate from anywhere in the U.S.

Study Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-03-30
• Study First Posted: 2018-04-06
• Study Start: 2019-07-24
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age: 6-11 years old at enrollment
• diagnosed with an autism spectrum disorder

Exclusion Criteria

• mast cell activation syndrome
• history of adverse response to essential oil inhalation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control Blend	Participants in this arm receive a control inhaler to administer during the 4-week intervention.
Test Essential Oil Blend	Test Essential Oil Blend	Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention.
Active Essential Oil Blend	Active Essential Oil Blend	Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.

Primary Outcome Measures

Name	Time	Method
39-Question Spence Children's Anxiety Scale (SCAS)	baseline and day 35	The Spence Children's Anxiety Scale collects parent-reported signs and symptoms of anxiety at baseline and again at the end of each week of the intervention. Each item is scored as (0) never, (1) sometimes (2) often, or (3)always. The total score ranges from 0-114, with higher scores indicating higher levels of anxiety.

Trial Locations

Locations (1)

Franklin Institute of Wellness; 🇺🇸 Franklin, Tennessee, United States