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The Effect of Aroma on Anxiety Among Children With Autism.

NCT ID: NCT03489811

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-24

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Anxiety Autism Spectrum Disorder

Keywords

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Essential Oils Aromatherapy Anxiety Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Test Essential Oil Blend

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

Group Type EXPERIMENTAL

Test Essential Oil Blend

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Active Essential Oil Blend

Intervention Type OTHER

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

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

Group Type PLACEBO_COMPARATOR

Control Blend

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Control Blend

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Franklin Institute of Wellness

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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17-2100

Identifier Type: -

Identifier Source: org_study_id