Back to resultsAromatherapy for Anxiety Among Children With Autism Spectrum Disorder
Primary Purpose
Anxiety, Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bergamot Aromatherapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Aromatherapy, Essential Oils, Children
Eligibility Criteria
Inclusion Criteria:
- Between 6-11 years of age
- Diagnosed with an autism spectrum disorder
Exclusion Criteria:
- none
Sites / Locations
- Franklin Institute of Wellness
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bergamot Aromatherapy
Control
Arm Description
Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.
Patients in this group did not experience an intervention.
Outcomes
Primary Outcome Measures
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.
Change from baseline in Blood Pressure
Routine blood pressure measurement
Change from baseline in Heart Rate
Routine heart rate measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT03818490
First Posted
January 22, 2019
Last Updated
January 24, 2019
Sponsor
Franklin Health Research
1. Study Identification
Unique Protocol Identification Number
NCT03818490
Brief Title
Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder
Official Title
Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 24, 2016 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Franklin Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Autism Spectrum Disorder
Keywords
Aromatherapy, Essential Oils, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bergamot Aromatherapy
Arm Type
Experimental
Arm Description
Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group did not experience an intervention.
Intervention Type
Other
Intervention Name(s)
Bergamot Aromatherapy
Intervention Description
Patients in this group inhaled bergamot essential oil for 15 minutes.
Primary Outcome Measure Information:
Title
Change from baseline State Trait Anxiety Inventory for Children
Description
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.
Time Frame
baseline and after the 15 minute intervention
Title
Change from baseline in Blood Pressure
Description
Routine blood pressure measurement
Time Frame
baseline and after the 15 minute intervention
Title
Change from baseline in Heart Rate
Description
Routine heart rate measurement
Time Frame
baseline and after the 15 minute intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between 6-11 years of age
Diagnosed with an autism spectrum disorder
Exclusion Criteria:
none
Facility Information:
Facility Name
Franklin Institute of Wellness
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder
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