ClinicalTrials.gg
WithdrawnNCT03489811Updated Nov 5, 2021

The Effect of Aroma on Anxiety Among Children With Autism.

An interventional study of Test Essential Oil Blend and Active Essential Oil Blend in Anxiety and Autism Spectrum Disorder, sponsored by Nutraceuticals Research Institute. Withdrawn at 1 site in United States. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-05.

Primary conditionAutism Spectrum DisorderRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Autism Spectrum Disorder
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Autism Spectrum Disorder.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Nutraceuticals Research Institute · Not applicable, Interventional, and Prevention

Why this study was withdrawn
COVID-19 pandemic introduced confounding factors that would bias the study data. Study rescheduled for future dates post-pandemic.

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Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 773 studies in Autism Spectrum Disorder with a site in United States — 166 open to participants now, 205 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.

Enrollment
639th of 658
0 · median 50
Started
2019
with 59 others
No phase
456 of 773
105 open now
Registered
301st of 773
by date

Among the 773 studies in Autism Spectrum Disorder with a site in United States, this one is the 639th largest by enrollment of the 658 interventional ones that give a count, is one of 60 that started in 2019, is one of 456 with no phase, and was the 301st registered.

Autism Spectrum Disorder

1,726 studies on the registry are indexed under Autism Spectrum Disorder; 501 are open to participants now.

Browse Autism Spectrum Disorder studies →

Open to participants now

166 of the 773 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:

161 more — sign in →

All 166 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 350 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 295 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.

This study: 6 Years to 11 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 773 studies in Autism Spectrum Disorder with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Anxiety
  • Autism Spectrum Disorder

Browse trials for

Keywords

  • Essential Oils
  • Aromatherapy
  • Anxiety
  • Autism Spectrum Disorder
04

In context

Autism Spectrum Disorder Reclassified

1,726 studies on the registry are indexed under Autism Spectrum Disorder; 501 are open to participants now.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Nutraceuticals Research Institute is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Compared within Autism Spectrum Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age: 6-11 years old at enrollment
  • diagnosed with an autism spectrum disorder

Exclusion criteria

Exclusion Criteria:

  • mast cell activation syndrome
  • history of adverse response to essential oil inhalation
06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

  • Placebo comparator
    Control

    Participants in this arm receive a control inhaler to administer during the 4-week intervention.

    Other: Control Blend

Interventions

  • OtherTest 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.

  • OtherActive 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.

  • OtherControl Blend

    The control blend consists of inert vegetable oils which are produced from plant matter.

07

What researchers measure

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.

    Time frame: baseline and day 35

08

Study locations

1 site
  • Franklin Institute of Wellness
    Franklin, Tennessee 37067, United States
09

References and documents

Individual participant data

Plan to share: No — Data will not be shared.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Aug 2021, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2018
First posted
Apr 6, 2018
StartActual
Jul 24, 2019
Primary completionActual
Aug 31, 2021
CompletionActual
Aug 31, 2021
Last update
Nov 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03489811
Lead sponsor
Nutraceuticals Research Institute
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Jul 24, 2019
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021
Last update
Nov 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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