The Effect of Aroma on Anxiety Among Children With Autism.

Franklin Health Research

Status: Withdrawn

Conditions: Autism Spectrum Disorder; Anxiety

Treatments: Other: Test Essential Oil Blend; Other: Control Blend; Other: Active Essential Oil Blend

Study type: Interventional

Funder types: Other

Identifiers

NCT03489811

17-2100

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 3 patient groups, including a placebo group

Test Essential Oil Blend

Experimental group

Description:

Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention.

Treatment:

Other: Test Essential Oil Blend

Active Essential Oil Blend

Active Comparator group

Description:

Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.

Treatment:

Other: Active Essential Oil Blend

Control

Placebo Comparator group

Description:

Participants in this arm receive a control inhaler to administer during the 4-week intervention.

Treatment:

Other: Control Blend