Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19 pandemic introduced confounding factors that would bias the study data. Study rescheduled for future dates post-pandemic.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Essential Oil Blend | Experimental | Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention. |
|
| Active Essential Oil Blend | Active Comparator | Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention. |
|
| Control | Placebo Comparator | Participants in this arm receive a control inhaler to administer during the 4-week intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Essential Oil Blend | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Institute of Wellness | Franklin | Tennessee | 37067 | United States |
Data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Essential Oil Blend | Other | 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. |
|
| Control Blend | Other | The control blend consists of inert vegetable oils which are produced from plant matter. |
|