AnxietyNCT03818490
Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder
A study testing Bergamot Aromatherapy in people with Anxiety and Autism Spectrum Disorder, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H 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?
- Bergamot Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2016to 30 Mar 2018
- 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
- Between 6-11 years of age
- Diagnosed with an autism spectrum disorder
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Institute of Wellness
Franklin, Tennessee, 37067
About this study
Official title: Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial
This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H
Read the detailed description
Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. Because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.
- Conditions
- Anxiety, Autism Spectrum Disorder
- Being tested
- Bergamot Aromatherapy
- Keywords
- Aromatherapy, Essential Oils, Children
- 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.
Bergamot AromatherapyOther
Patients in this group inhaled bergamot essential oil for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Bergamot Aromatherapy | Experimental | Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit. Receives: Other: Bergamot Aromatherapy |
| Control | No intervention | Patients in this group did not experience an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline State Trait Anxiety Inventory for Children
Self reported anxiety survey measuring state anxiety in children through 20 questions with a score ranging from 0-60 with higher scores representing higher anxiety.
Measured: baseline and after the 15 minute intervention
Change from baseline in Blood Pressure
Routine blood pressure measurement
Measured: baseline and after the 15 minute intervention
Change from baseline in Heart Rate
Routine heart rate measurement
Measured: baseline and after the 15 minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start24 Jun 2016
- Primary completion9 Mar 2018
- Study completion30 Mar 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessie Hawkins, PhD, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818490
- Sponsor's protocol ID
- 17-1200
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03818490
- Acronym / sponsor ID
- 17-1200
- Conditions
- Anxiety, Autism Spectrum Disorder
- Keywords
- Aromatherapy, Essential Oils, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 28 Jan 2019 (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 evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H
Detailed description
Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. Because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bergamot Aromatherapy | Experimental | Other: Bergamot AromatherapyPatients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit. |
| Control | No intervention | –Patients in this group did not experience an intervention. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Between 6-11 years of age
- Diagnosed with an autism spectrum disorder
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Bergamot AromatherapyPatients in this group inhaled bergamot essential oil for 15 minutes. | Other | Bergamot Aromatherapy |
Primary outcome
Change from baseline State Trait Anxiety Inventory for Children
Time frame: baseline and after the 15 minute intervention
Self reported anxiety survey measuring state anxiety in children through 20 questions with a score ranging from 0-60 with higher scores representing higher anxiety.
Change from baseline in Blood Pressure
Time frame: baseline and after the 15 minute intervention
Routine blood pressure measurement
Change from baseline in Heart Rate
Time frame: baseline and after the 15 minute intervention
Routine heart rate measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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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 Bergamot Aromatherapy 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 1 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: finished, as of the sponsor's last update on 28 Jan 2019. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline State Trait Anxiety Inventory for Children (time frame: baseline and after the 15 minute intervention). The study lists 3 primary outcomes in all. 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 28 Jan 2019.