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Clinical Trials/NCT03818490
NCT03818490
Completed
Not Applicable

Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial

Franklin Health Research1 site in 1 country28 target enrollmentJune 24, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Franklin Health Research
Enrollment
28
Locations
1
Primary Endpoint
Change from baseline in Heart Rate
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2016
End Date
March 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Franklin Health Research
Responsible Party
Principal Investigator
Principal Investigator

Jessie Hawkins, PhD

Research Director

Franklin Health Research

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline in Heart Rate

Time Frame: baseline and after the 15 minute intervention

Routine heart rate measurement

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.

Change from baseline in Blood Pressure

Time Frame: baseline and after the 15 minute intervention

Routine blood pressure measurement

Study Sites (1)

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