NCT03818490

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

January 22, 2019

Last Update Submit

January 24, 2019

Conditions

AnxietyAutism Spectrum Disorder

Keywords

AromatherapyEssential OilsChildren

Outcome Measures

Primary Outcomes (3)

  • 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.

    baseline and after the 15 minute intervention

  • Change from baseline in Blood Pressure

    Routine blood pressure measurement

    baseline and after the 15 minute intervention

  • Change from baseline in Heart Rate

    Routine heart rate measurement

    baseline and after the 15 minute intervention

Study Arms (2)

Bergamot Aromatherapy

EXPERIMENTAL

Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.

Other: Bergamot Aromatherapy

Control

NO INTERVENTION

Patients in this group did not experience an intervention.

Interventions

Bergamot AromatherapyOTHER

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

Bergamot Aromatherapy

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Institute of Wellness

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Anxiety DisordersAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Mental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 28, 2019

Study Start

June 24, 2016

Primary Completion

March 9, 2018

Study Completion

March 30, 2018

Last Updated

January 28, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)