The Effect of Aroma on Anxiety Among Children With Autism.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03489811|
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Autism Spectrum Disorder||Other: Test Essential Oil Blend Other: Active Essential Oil Blend Other: Control Blend||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Aroma on Anxiety Among Children With Autism.|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||September 21, 2018|
Experimental: Test Essential Oil Blend
Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention.
Other: Test Essential Oil Blend
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.
Active Comparator: Active Essential Oil Blend
Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention.
Other: Active Essential Oil Blend
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.
Placebo Comparator: Control
Participants in this arm receive a control inhaler to administer during the 4-week intervention.
Other: Control Blend
The control blend consists of inert vegetable oils which are produced from plant matter.
- 39-Question Spence Children's Anxiety Scale (SCAS) [ Time Frame: once a week for 5 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489811
|Contact: Jessie Hawkins, PhDfirstname.lastname@example.org|
|United States, Tennessee|
|Franklin Institute of Wellness||Recruiting|
|Franklin, Tennessee, United States, 37067|
|Contact: Jessie Hawkins, PhD 615-261-3116 email@example.com|