- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473544
Essential Oil Inhalation and Acute Stress Response in Healthy Adults (DMA)
Evaluation of Aromatic Essential Oils in Conditions of Stress and Relaxation - A Double-Blind, Randomized, Placebo-Controlled Trial
This randomized, double-blind, placebo-controlled study evaluates the acute physiological and subjective responses to essential oil inhalation in healthy adults. Participants are assigned to inhale either an essential oil or a placebo via an aroma stick during standardized laboratory procedures designed to induce temporary psychosocial stress (Trier Social Stress Test - Group version) and during a guided relaxation session.
Physiological responses, including heart rate, heart rate variability, and electrodermal activity, are measured using a wearable sensor. Subjective stress and affect are assessed using validated questionnaires and visual analog scales. The purpose of this study is to characterize short-term autonomic and self-reported responses associated with essential oil inhalation under controlled experimental conditions. This study is exploratory and is not intended to diagnose, treat, or prevent any medical condition.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Essential oils and essential oil blends are widely used in non-clinical settings; however, objective data describing short-term physiological and subjective responses to inhalation under controlled experimental conditions remain limited. This study is designed to evaluate acute autonomic and self-reported responses to essential oil inhalation during standardized laboratory procedures involving psychosocial stress and guided relaxation.
This is a randomized, double-blind, placebo-controlled, parallel-group study conducted in healthy adults aged 18-45 years. Participants are assigned to inhale either an essential oil (or essential oil blend) or a placebo comparator administered via an identical aroma stick. Inhalation occurs at standardized time points during two study visits.
During Study Visit 1, participants undergo the Trier Social Stress Test - Group version (TSST-G), a validated laboratory paradigm designed to induce temporary psychosocial stress through public speaking and mental arithmetic tasks performed under observation. Inhalation occurs during baseline, preparation, stress, and recovery phases. During Study Visit 2, participants undergo a structured guided meditation session under controlled environmental conditions, with inhalation occurring at standardized intervals.
Physiological measures are collected continuously using a wrist-worn wearable device capable of measuring heart rate, heart rate variability (HRV), and electrodermal activity (EDA). Subjective responses are assessed using validated instruments including visual analog scales for stress and calm, PROMIS Anxiety, GAD-7, and PANAS. The primary outcome is change in stress response as measured by area under the curve (AUC) for visual analog scale stress scores across the stress and recovery period.
The study employs an adaptive design with an initial planned enrollment of 100 participants (50 per arm) and a prespecified interim analysis for potential expansion to a maximum of 200 participants. Statistical analyses include comparison of stress and physiological responses between groups using baseline-adjusted models.
This study is exploratory in nature and is intended to characterize acute responses associated with essential oil inhalation under controlled conditions. It is not designed to diagnose, treat, mitigate, or prevent any disease or medical condition.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Utah
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Pleasant Grove, Utah, United States, 84062
- dōTERRA International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 18-45 years, inclusive
Able to read, write, and understand English
Willing and able to provide informed consent
Willing to attend two in-person study visits
Generally healthy, as determined by medical history and screening review
Exclusion Criteria:
Known asthma, chronic obstructive pulmonary disease (COPD), significant lung disease, heart disease, or other medical condition that may compromise safety or data integrity
Pregnancy or pregnancy within the past 90 days
Known allergy or sensitivity to essential oils or study placebo materials
Current smoking, vaping, chewing tobacco, or use of recreational drugs
Regular use of essential oils applicable to the study phase (>3 times per week for ≥2 weeks within the past month) without a minimum 1-month washout
Unwillingness to abstain from alcohol for at least 72 hours prior to each study visit
Failure to meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Essential Oil Inhalation
Participants inhale an essential oil or essential oil blend via an individual aroma stick during standardized stress induction (TSST-G) and guided relaxation procedures across two study visits.
|
Participants inhale an essential oil or essential oil blend administered via an individual aroma stick.
At prespecified time points during baseline, stress induction (Trier Social Stress Test - Group version), and recovery or guided meditation procedures, participants are instructed to take five normal breaths from the aroma stick.
The intervention is delivered in a randomized, double-blind manner and is standardized across participants within each study phase.
|
|
Placebo Comparator: Placebo Inhalation
Participants inhale a placebo aroma stick matched in appearance and delivery method but without active essential oil components during identical stress and relaxation procedures.
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Participants inhale a placebo comparator administered via an aroma stick identical in appearance and delivery method to the experimental intervention but without active essential oil components.
The inhalation schedule and procedures are identical to those used in the experimental arm to maintain blinding.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Stress Area Under the Curve (AUC)
Time Frame: Baseline through 30 minutes post-stressor recovery (Study Visit 1)
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Area under the curve (AUC) for self-reported stress measured using a Visual Analog Scale (VAS) across baseline, stress induction (Trier Social Stress Test - Group version), and post-stressor recovery periods.
The VAS-stress scale ranges from low stress to high stress, with higher scores indicating greater perceived stress.
|
Baseline through 30 minutes post-stressor recovery (Study Visit 1)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart Rate During Stress and Recovery
Time Frame: Baseline through 30 minutes post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline
|
Mean heart rate measured using a wearable sensor during baseline, stress induction (Trier Social Stress Test - Group version), and post-stressor recovery.
A higher heart rate, measured beats per minute (BPM), indicates higher stress.
|
Baseline through 30 minutes post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline
|
|
Change in Electrodermal Activity During Stress and Recovery
Time Frame: Baseline through 30 minutes post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline.
|
Tonic electrodermal activity measured using a wearable sensor during baseline, stress induction, and recovery periods.
This is measured in microsiemens, which is the SI unit of conductance.
Higher tonic ectodermal activity indicates higher stress.
|
Baseline through 30 minutes post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline.
|
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Change in PROMIS Anxiety Scores
Time Frame: Baseline and post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline.
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PROMIS Anxiety short form scores collected at baseline and during post-stressor recovery to assess subjective anxiety symptoms.
A higher score indicates higher anxiety.
The measurement scale ranges from 1 ("never") to 5 ("always").
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Baseline and post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline.
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Change in Positive and Negative Affect Schedule (PANAS) Scores
Time Frame: Baseline and post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline
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PANAS scores assessing positive and negative affect collected at baseline and post-stressor recovery.
The rating scale ranges from 1 ("Very slightly or not at all") to 5 ("extremely").
Higher scores with regard to the positive affect questions indicate greater levels of joy, enthusiasm, and active engagement.
Higher scores with regard to the negative affect questions indicate higher levels of fear, anger, or distress.
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Baseline and post-stressor recovery (Study Visit 1), approximately 90 minutes from baseline
|
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Change in Visual Analog Scale (VAS) Calm Scores
Time Frame: Baseline through 30 minutes post-stressor recovery (Study Visit 1), approximately 90 minutes after baseline.
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Self-reported calmness measured using a visual analog scale across baseline, stress, and recovery phases.
It is measured on a score of 0 to 100, with 0 representing "Not at all", and 100 representing "extremely".
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Baseline through 30 minutes post-stressor recovery (Study Visit 1), approximately 90 minutes after baseline.
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Incidence of Adverse Events
Time Frame: Through completion of Study Visit 2, up to 1 week post baseline.
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Number and severity of participant-reported adverse events occurring during study visits.
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Through completion of Study Visit 2, up to 1 week post baseline.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicole Stevens, PhD, DoTERRA International LLC.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DO-126042-DMA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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