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Completed

NCT Number: NCT03818490

Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder

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

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Key information

Conditions

Anxiety Anxiety Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Institute of Wellness

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Bergamot Aromatherapy

Other

Patients in this group inhaled bergamot essential oil for 15 minutes.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2019
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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