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Trial record 66 of 237 for:    essential oil

Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03818490
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Jessie Hawkins, PhD, Franklin Institute of Wellness

Brief 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

Condition or disease Intervention/treatment Phase
Anxiety Autism Spectrum Disorder Other: Bergamot Aromatherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bergamot Aromatherapy
Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.
Other: Bergamot Aromatherapy
Patients in this group inhaled bergamot essential oil for 15 minutes.

No Intervention: Control
Patients in this group did not experience an intervention.



Primary Outcome Measures :
  1. Change from baseline State Trait Anxiety Inventory for Children [ Time Frame: baseline and after the 15 minute intervention ]
    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.

  2. Change from baseline in Blood Pressure [ Time Frame: baseline and after the 15 minute intervention ]
    Routine blood pressure measurement

  3. Change from baseline in Heart Rate [ Time Frame: baseline and after the 15 minute intervention ]
    Routine heart rate measurement



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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:

  • Between 6-11 years of age
  • Diagnosed with an autism spectrum disorder

Exclusion Criteria:

  • none

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): NCT03818490


Locations
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United States, Tennessee
Franklin Institute of Wellness
Franklin, Tennessee, United States, 37067
Sponsors and Collaborators
Franklin Institute of Wellness

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Responsible Party: Jessie Hawkins, PhD, Research Director, Franklin Institute of Wellness
ClinicalTrials.gov Identifier: NCT03818490     History of Changes
Other Study ID Numbers: 17-1200
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jessie Hawkins, PhD, Franklin Institute of Wellness:
Aromatherapy
Essential Oils
Children
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders
Neurodevelopmental Disorders