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The Effect of Aroma on Anxiety Among Children With Autism.

Primary Purpose

Anxiety, Autism Spectrum Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Essential Oil Blend
Active Essential Oil Blend
Control Blend
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Essential Oils, Aromatherapy, Anxiety, Autism Spectrum Disorder

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age: 6-11 years old at enrollment
  • diagnosed with an autism spectrum disorder

Exclusion Criteria:

  • mast cell activation syndrome
  • history of adverse response to essential oil inhalation

Sites / Locations

  • Franklin Institute of Wellness

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test Essential Oil Blend

Active Essential Oil Blend

Control

Arm Description

Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention.

Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.

Participants in this arm receive a control inhaler to administer during the 4-week intervention.

Outcomes

Primary Outcome Measures

39-Question Spence Children's Anxiety Scale (SCAS)
The Spence Children's Anxiety Scale collects parent-reported signs and symptoms of anxiety at baseline and again at the end of each week of the intervention. Each item is scored as (0) never, (1) sometimes (2) often, or (3)always. The total score ranges from 0-114, with higher scores indicating higher levels of anxiety.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2018
Last Updated
October 29, 2021
Sponsor
Franklin Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT03489811
Brief Title
The Effect of Aroma on Anxiety Among Children With Autism.
Official Title
The Effect of Aroma on Anxiety Among Children With Autism.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 pandemic introduced confounding factors that would bias the study data. Study rescheduled for future dates post-pandemic.
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.
Detailed Description
Essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder. The essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. The oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils. Anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. Parents complete this data online, allowing them to participate from anywhere in the U.S.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Autism Spectrum Disorder
Keywords
Essential Oils, Aromatherapy, Anxiety, Autism Spectrum Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Essential Oil Blend
Arm Type
Experimental
Arm Description
Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention.
Arm Title
Active Essential Oil Blend
Arm Type
Active Comparator
Arm Description
Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants in this arm receive a control inhaler to administer during the 4-week intervention.
Intervention Type
Other
Intervention Name(s)
Test Essential Oil Blend
Intervention Description
The test essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
Intervention Type
Other
Intervention Name(s)
Active Essential Oil Blend
Intervention Description
The active essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
Intervention Type
Other
Intervention Name(s)
Control Blend
Intervention Description
The control blend consists of inert vegetable oils which are produced from plant matter.
Primary Outcome Measure Information:
Title
39-Question Spence Children's Anxiety Scale (SCAS)
Description
The Spence Children's Anxiety Scale collects parent-reported signs and symptoms of anxiety at baseline and again at the end of each week of the intervention. Each item is scored as (0) never, (1) sometimes (2) often, or (3)always. The total score ranges from 0-114, with higher scores indicating higher levels of anxiety.
Time Frame
baseline and day 35

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: age: 6-11 years old at enrollment diagnosed with an autism spectrum disorder Exclusion Criteria: mast cell activation syndrome history of adverse response to essential oil inhalation
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
IPD Sharing Plan Description
Data will not be shared.

Learn more about this trial

The Effect of Aroma on Anxiety Among Children With Autism.

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