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Trial record 34 of 237 for:    essential oil

The Effect of Aroma on Anxiety Among Children With Autism.

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ClinicalTrials.gov Identifier: NCT03489811
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Franklin Institute of Wellness

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Autism Spectrum Disorder Other: Test Essential Oil Blend Other: Active Essential Oil Blend Other: Control Blend Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Aroma on Anxiety Among Children With Autism.
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : September 21, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 39-Question Spence Children's Anxiety Scale (SCAS) [ Time Frame: once a week for 5 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489811


Contacts
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Contact: Jessie Hawkins, PhD 615-261-3116 info@franklininstituteofwellness.com

Locations
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United States, Tennessee
Franklin Institute of Wellness Recruiting
Franklin, Tennessee, United States, 37067
Contact: Jessie Hawkins, PhD    615-261-3116    info@franklininstituteofwellness.com   
Sponsors and Collaborators
Franklin Institute of Wellness

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Responsible Party: Franklin Institute of Wellness
ClinicalTrials.gov Identifier: NCT03489811     History of Changes
Other Study ID Numbers: 17-2100
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Institute of Wellness:
Essential Oils
Aromatherapy
Anxiety
Autism Spectrum Disorder
Additional relevant MeSH terms:
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Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders