AnxietyNCT03489811
The Effect of Aroma on Anxiety Among Children With Autism.
A study testing Test Essential Oil Blend and Active Essential Oil Blend in people with Anxiety and Autism Spectrum Disorder, run by Nutraceuticals Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Autism Spectrum Disorder
- What is being tested?
- Test Essential Oil Blend and Active Essential Oil Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age: 6-11 years old at enrollment
- diagnosed with an autism spectrum disorder
Who cannot join
- mast cell activation syndrome
- history of adverse response to essential oil inhalation
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Institute of Wellness
Franklin, Tennessee, 37067
About this study
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.
Read the 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.
- Conditions
- Anxiety, Autism Spectrum Disorder
- Being tested
- Test Essential Oil Blend, Active Essential Oil Blend, Control Blend
- Keywords
- Essential Oils, Aromatherapy, Anxiety, Autism Spectrum Disorder
- Medical subject headings
- Anxiety Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Essential Oil BlendOther
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 Essential Oil BlendOther
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 BlendOther
The control blend consists of inert vegetable oils which are produced from plant matter.
| Study group | Role | What they receive |
|---|---|---|
| Test Essential Oil Blend | Experimental | Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention. Receives: Other: Test Essential Oil Blend |
| Active Essential Oil Blend | Active comparator | Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention. Receives: Other: Active Essential Oil Blend |
| Control | Placebo comparator | Participants in this arm receive a control inhaler to administer during the 4-week intervention. Receives: Other: Control Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start24 Jul 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: COVID-19 pandemic introduced confounding factors that would bias the study data. Study rescheduled for future dates post-pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489811
- Sponsor's protocol ID
- 17-2100
- Status last verified
- Oct 2021
- First submitted
- 30 Mar 2018
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aroma on Anxiety Among Children With Autism.
- ClinicalTrials.gov ID
- NCT03489811
- Acronym / sponsor ID
- 17-2100
- Conditions
- Anxiety, Autism Spectrum Disorder
- Keywords
- Essential Oils, Aromatherapy, Anxiety, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic introduced confounding factors that would bias the study data. Study rescheduled for future dates post-pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Essential Oil Blend | Experimental | Other: Test Essential Oil BlendParticipants in this arm receive the test essential oil inhaler to administer during the 4-week intervention. |
| Active Essential Oil Blend | Active comparator | Other: Active Essential Oil BlendParticipants in this arm receive an active essential oil inhaler to administer during the 4-week intervention. |
| Control | Placebo comparator | Other: Control BlendParticipants in this arm receive a control inhaler to administer during the 4-week intervention. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age: 6-11 years old at enrollment
- diagnosed with an autism spectrum disorder
Key exclusion criteria (2 listed)
- mast cell activation syndrome
- history of adverse response to essential oil inhalation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Essential Oil BlendThe 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. | Other | Test Essential Oil Blend |
| Active Essential Oil BlendThe 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. | Other | Active Essential Oil Blend |
| Control BlendThe control blend consists of inert vegetable oils which are produced from plant matter. | Other | Control |
Primary outcome
39-Question Spence Children's Anxiety Scale (SCAS)
Time frame: baseline and day 35
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No. Data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Essential Oil Blend and Active Essential Oil Blend in people with Anxiety and Autism Spectrum Disorder, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
39-Question Spence Children's Anxiety Scale (SCAS) (time frame: baseline and day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.