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The Effect of Aroma on Anxiety Among Children With Autism.

The Effect of Aroma on Anxiety Among Children With Autism.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03489811
Enrollment
0
Registered
2018-04-06
Start date
2019-07-24
Completion date
2021-08-31
Last updated
2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Autism Spectrum Disorder

Keywords

Essential Oils, Aromatherapy, Anxiety, Autism Spectrum Disorder

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.

Interventions

OTHERTest Essential Oil Blend

The test essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.

OTHERActive Essential Oil Blend

The active essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.

The control blend consists of inert vegetable oils which are produced from plant matter.

Sponsors

Nutraceuticals Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
39-Question Spence Children's Anxiety Scale (SCAS)baseline and day 35The 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026