Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder

Anxiety Clinical Trial

Official title:

Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818490
• Other study ID #: 17-1200
• Status: Completed
• Phase: N/A
• Start date: June 24, 2016
• Est. completion date: March 30, 2018

Study information

• Verified date: January 2019
• Source: Franklin Institute of Wellness
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H

Description:

Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. Because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 30, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• Between 6-11 years of age

• Diagnosed with an autism spectrum disorder

Exclusion Criteria:

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Other:
• Bergamot Aromatherapy
Patients in this group inhaled bergamot essential oil for 15 minutes.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Institute of Wellness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline State Trait Anxiety Inventory for Children	Self reported anxiety survey measuring state anxiety in children through 20 questions with a score ranging from 0-60 with higher scores representing higher anxiety.	baseline and after the 15 minute intervention
Primary	Change from baseline in Blood Pressure	Routine blood pressure measurement	baseline and after the 15 minute intervention
Primary	Change from baseline in Heart Rate	Routine heart rate measurement	baseline and after the 15 minute intervention