Study Stopped
COVID-19 pandemic introduced confounding factors that would bias the study data. Study rescheduled for future dates post-pandemic.
The Effect of Aroma on Anxiety Among Children With Autism.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Typical duration for not_applicable anxiety
1 active site
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
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedStudy Start
First participant enrolled
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedNovember 5, 2021
October 1, 2021
2.1 years
March 30, 2018
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline and day 35
Study Arms (3)
Test Essential Oil Blend
EXPERIMENTALParticipants in this arm receive the test essential oil inhaler to administer during the 4-week intervention.
Active Essential Oil Blend
ACTIVE COMPARATORParticipants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.
Control
PLACEBO COMPARATORParticipants in this arm receive a control inhaler to administer during the 4-week intervention.
Interventions
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.
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.
The control blend consists of inert vegetable oils which are produced from plant matter.
Eligibility Criteria
You may qualify if:
- age: 6-11 years old at enrollment
- diagnosed with an autism spectrum disorder
You may not qualify if:
- mast cell activation syndrome
- history of adverse response to essential oil inhalation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Franklin Institute of Wellness
Franklin, Tennessee, 37067, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 6, 2018
Study Start
July 24, 2019
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
Data will not be shared.