The Effect of Aroma on Anxiety Among Children With Autism.

Anxiety Clinical Trial

Official title:

The Effect of Aroma on Anxiety Among Children With Autism.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03489811
• Other study ID #: 17-2100
• Status: Withdrawn
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: Franklin School of Integrative Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Test 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.
• Active 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.
• Control Blend
The control blend consists of inert vegetable oils which are produced from plant matter.

Locations

Country	Name	City	State
United States	Franklin Institute of Wellness	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin School of Integrative Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	39-Question Spence Children's Anxiety Scale (SCAS)	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.	baseline and day 35