Psychological StressDMANCT07473544
Essential Oil Inhalation and Acute Stress Response in Healthy Adults
A study testing Essential Oil Inhalation in people with Psychological Stress, run by dōTERRA International at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Essential Oil Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Stress
- Being tested
- Essential Oil Inhalation, Placebo Aroma Stick
- Keywords
- Stress, Aromatherapy, Essential Oils, Autonomic Nervous System, Stress Reactivity, acute stress, anxiety
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Oil InhalationOther
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 Aroma StickOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Essential Oil Inhalation | Experimental | 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. Receives: Other: Essential Oil Inhalation |
| Placebo Inhalation | Placebo comparator | Participants inhale a placebo aroma stick matched in appearance and delivery method but without active essential oil components during identical stress and relaxation procedures. Receives: Other: Placebo Aroma Stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Stress Area Under the Curve (AUC)
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.
Measured: Baseline through 30 minutes post-stressor recovery (Study Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups: essential oil inhalation or placebo inhalation. Randomization is maintained across two study visits. Participants remain in their assigned group for the duration of the study. An initial cohort of 100 participants (50 per arm) will be enrolled, with a prespecified interim analysis to determine whether enrollment will expand to a maximum of 200 participants.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dōTERRA International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Stevens, PhD, Principal investigator, DoTERRA International LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473544
- Sponsor's protocol ID
- DO-126042-DMA
- Acronym
- DMA
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aromatic Essential Oils in Conditions of Stress and Relaxation - A Double-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07473544
- Acronym / sponsor ID
- DMA / DO-126042-DMA
- Conditions
- Psychological Stress
- Keywords
- Stress, Aromatherapy, Essential Oils, Autonomic Nervous System, Stress Reactivity, acute stress, anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- dōTERRA InternationalIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups: essential oil inhalation or placebo inhalation. Randomization is maintained across two study visits. Participants remain in their assigned group for the duration of the study. An initial cohort of 100 participants (50 per arm) will be enrolled, with a prespecified interim analysis to determine whether enrollment will expand to a maximum of 200 participants.
| Arm | Type | Receives |
|---|---|---|
| Essential Oil Inhalation | Experimental | Other: Essential Oil InhalationParticipants 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. |
| Placebo Inhalation | Placebo comparator | Other: Placebo Aroma StickParticipants inhale a placebo aroma stick matched in appearance and delivery method but without active essential oil components during identical stress and relaxation procedures. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Essential Oil InhalationParticipants 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. | Other | Essential Oil Inhalation |
| Placebo Aroma StickParticipants 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. | Other | Placebo Inhalation |
Primary outcome
Change in Visual Analog Scale (VAS) Stress Area Under the Curve (AUC)
Time frame: Baseline through 30 minutes post-stressor recovery (Study Visit 1)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
Nicole Stevens, PhD principal investigator
DoTERRA International LLC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil Inhalation in people with Psychological Stress, run by dōTERRA International 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 in Visual Analog Scale (VAS) Stress Area Under the Curve (AUC) (time frame: Baseline through 30 minutes post-stressor recovery (Study Visit 1)). 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 12 May 2026.