The Effect of Aroma on Anxiety Among Children With Autism.

October 29, 2021 updated by: Franklin Health Research
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Franklin Institute of Wellness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Essential Oil Blend
Participants in this arm receive the test essential oil inhaler to administer during the 4-week 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 Comparator: Active Essential Oil Blend
Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.
Other: 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.
Placebo Comparator: Control
Participants in this arm receive a control inhaler to administer during the 4-week intervention.
Other: Control Blend
The control blend consists of inert vegetable oils which are produced from plant matter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
39-Question Spence Children's Anxiety Scale (SCAS)
Time Frame: 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.
baseline and day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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