MigraineNCT07493434
Evaluation of Pain Thresholds in Migraine Patients After Inhalation of Essential Oils: a Randomized Clinical Trial
A study testing Lavander essential oil, Peppermint essential oil and Lavandula angustifolia and Mentha Piperita in people with Migraine, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study will test whether inhaling essential oils can change how sensitive people with migraine are to pressure pain. Participants will be allocated to inhale lavender, peppermint, a combination of both, or a control solution (distilled water with coconut oil). Each group will have 50 participants. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine
- What is being tested?
- Lavander essential oil, Peppermint essential oil and Lavandula angustifolia and Mentha Piperita
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Mar 2025to Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-65 years
- Diagnosis of episodic or chronic migraine according to the Internactional Classification of Headache Disorders (ICDH-3)
- History of migraine for at least 1 year
- Ability to understand and provide informed consent
- Participants currently using or not using migraine preventive medication
Who cannot join
- Severe acute circulatory disorders
- Diabetes melitus
- Uncontrolled arterial hypertension
- Fribromyagia
- Anosmia or hyposmia
- Known allergy or hypersensitivity to essential oils or their components
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Intitute of Psychiatry- Hospital das Clínicas, University of São Paulo
São Paulo, São Paulo, 11
About this study
This study will test whether inhaling essential oils can change how sensitive people with migraine are to pressure pain. Participants will be allocated to inhale lavender, peppermint, a combination of both, or a control solution (distilled water with coconut oil). Each group will have 50 participants. The inhalation will last 15 minutes and will happen only once. Before and after the inhalation, we will measure how much pressure on certain areas of the head.
Read the detailed description
This is a parallel, randomized, placebo-controlled clinical trial to evaluate pain thresholds before and after the inhalation of essential oils or a control, in patients of both genders diagnosed with migraine. There will be three experimental groups, each with 50 participants (lavender, peppermint, and a combination of lavender and peppermint) and one control group with 50 participants (distilled water with coconut oil). The intervention will be conducted in a single session lasting 15 minutes, and participants will be evaluated before and immediately after the inhalation of the essential oils or control by measuring their pain thresholds in the following cephalic regions: occipital, masseter, temporal, vertex, and frontal. The randomization sequence will be generated by a statistician using the R software. The resulting randomization list will be stored in a sealed envelope and handled by an assistant evaluator who will not take part in the intervention. Participants will be allocated according to the random sequence based on their order of arrival.
- Conditions
- Migraine
- Being tested
- Lavander essential oil, Peppermint essential oil, Lavandula angustifolia and Mentha Piperita, Coconut oil
- Keywords
- migraine, pain pressure threshold, volatile oils
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavander essential oilOther
Lavander essential oil (Lavandula angustifolia) administered by inhalation. Six drops are applied via individual inhaler wick for inhalation during a 15- minute experimental session.
Peppermint essential oilOther
Peppermint essential oil (Mentha piperita) administered by inhalation. Six drops are applied via inhaler wick for inhalation during a 15-minute experimental session.
Lavandula angustifolia and Mentha PiperitaOther
A combination of lavander (Lavandula angustifolia) and peppermint (Mentha piperita) essential oils administered by inhalation. Three drops of each administered via inhaler wick for inhalation during 15-minute experimental session.
Coconut oilOther
A placebo control solution consisting of coconut oil and distilled water adminstered by inhalation. Six drops of the mixture during a 15-minute experimental session.
| Study group | Role | What they receive |
|---|---|---|
| Lavander essential oil | Experimental | Participants inhale lavander essential oil (Lavandula angustifolia) administered via inhalation for 15 minutes during the experimental session Receives: Other: Lavander essential oil |
| Control (Coconut oil and distilled water) | Placebo comparator | Participants inhale a control solution consisting of coconut oil and distilled water, administered via inhalation for 15 minutes during the experimental session Receives: Other: Coconut oil |
| Peppermint essential oil | Experimental | Participants inhale peppermint essential oil (Mentha piperita) administered via inhalation for 15 minutes during the experimental session Receives: Other: Peppermint essential oil |
| Peppemint and lavander essential oil | Experimental | Participants inhale a combination of peppermint (Mentha piperita) an lavander (Lavandula angustifolia) essential oils administered via inhalation for 15 minutes during the experimental session Receives: Other: Lavandula angustifolia and Mentha Piperita |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Pain pressure threshold mensured using a digital algometer at standardized craniofacial sites (masseter, temporalis, frontal, occipital and vertex) before and after inhalation of essential oils.
Measured: Baseline (pre- inhalation) and immediately after inhalation (within 15 minutes)
Secondary outcomes (1)
Hedonic perception of the aroma
Immediately after inhalatioan (within 30 minutes)
Measured: Participants will report the perceveid pleasantness of inhaled aroma using standardized 9- point hedonic scale ranging from "extremely unpleasant" to "extremely pleasant"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start13 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an intervencional, parallel, randomized, double-blind, placebo-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanda de Lelis, University of Sao Paulo
- Investigators
- Mario F Peres, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493434
- Sponsor's protocol ID
- 85802124.1.0000.0068
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable and non-sensitive individual participant data will be shared for academic and scientific purposes. The data will be available after the study is completed, for an indefinite period, through a virtual platform. The following will be shared: study design, statistical analysis plan, and consolidated research results. Access will be granted to interested researchers upon formal request, exclusively for secondary analyses, systematic reviews, or meta-analyses, with a commitment to ethical and academic use.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Thresholds in Migraine Patients After Inhalation of Essential Oils: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07493434
- Acronym / sponsor ID
- 85802124.1.0000.0068
- Conditions
- Migraine
- Keywords
- migraine, pain pressure threshold, volatile oils
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 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 study will test whether inhaling essential oils can change how sensitive people with migraine are to pressure pain. Participants will be allocated to inhale lavender, peppermint, a combination of both, or a control solution (distilled water with coconut oil). Each group will have 50 participants. The inhalation will last 15 minutes and will happen only once. Before and after the inhalation, we will measure how much pressure on certain areas of the head.
Detailed description
This is a parallel, randomized, placebo-controlled clinical trial to evaluate pain thresholds before and after the inhalation of essential oils or a control, in patients of both genders diagnosed with migraine. There will be three experimental groups, each with 50 participants (lavender, peppermint, and a combination of lavender and peppermint) and one control group with 50 participants (distilled water with coconut oil). The intervention will be conducted in a single session lasting 15 minutes, and participants will be evaluated before and immediately after the inhalation of the essential oils or control by measuring their pain thresholds in the following cephalic regions: occipital, masseter, temporal, vertex, and frontal. The randomization sequence will be generated by a statistician using the R software. The resulting randomization list will be stored in a sealed envelope and handled by an assistant evaluator who will not take part in the intervention. Participants will be allocated according to the random sequence based on their order of arrival.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is an intervencional, parallel, randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lavander essential oil | Experimental | Other: Lavander essential oilParticipants inhale lavander essential oil (Lavandula angustifolia) administered via inhalation for 15 minutes during the experimental session |
| Control (Coconut oil and distilled water) | Placebo comparator | Other: Coconut oilParticipants inhale a control solution consisting of coconut oil and distilled water, administered via inhalation for 15 minutes during the experimental session |
| Peppermint essential oil | Experimental | Other: Peppermint essential oilParticipants inhale peppermint essential oil (Mentha piperita) administered via inhalation for 15 minutes during the experimental session |
| Peppemint and lavander essential oil | Experimental | Other: Lavandula angustifolia and Mentha PiperitaParticipants inhale a combination of peppermint (Mentha piperita) an lavander (Lavandula angustifolia) essential oils administered via inhalation for 15 minutes during the experimental session |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Diagnosis of episodic or chronic migraine according to the Internactional Classification of Headache Disorders (ICDH-3)
- History of migraine for at least 1 year
- Ability to understand and provide informed consent
- Participants currently using or not using migraine preventive medication
Key exclusion criteria (7 listed)
- Severe acute circulatory disorders
- Diabetes melitus
- Uncontrolled arterial hypertension
- Fribromyagia
- Anosmia or hyposmia
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 |
|---|---|---|
| Lavander essential oilLavander essential oil (Lavandula angustifolia) administered by inhalation. Six drops are applied via individual inhaler wick for inhalation during a 15- minute experimental session. | Other | Lavander essential oil |
| Peppermint essential oilPeppermint essential oil (Mentha piperita) administered by inhalation. Six drops are applied via inhaler wick for inhalation during a 15-minute experimental session. | Other | Peppermint essential oil |
| Lavandula angustifolia and Mentha PiperitaA combination of lavander (Lavandula angustifolia) and peppermint (Mentha piperita) essential oils administered by inhalation. Three drops of each administered via inhaler wick for inhalation during 15-minute experimental session. | Other | Peppemint and lavander essential oil |
| Coconut oilA placebo control solution consisting of coconut oil and distilled water adminstered by inhalation. Six drops of the mixture during a 15-minute experimental session. | Other | Control (Coconut oil and distilled water) |
Primary outcome
Pain pressure threshold
Time frame: Baseline (pre- inhalation) and immediately after inhalation (within 15 minutes)
Pain pressure threshold mensured using a digital algometer at standardized craniofacial sites (masseter, temporalis, frontal, occipital and vertex) before and after inhalation of essential oils.
1 secondary outcome
Hedonic perception of the aroma
Time frame: Participants will report the perceveid pleasantness of inhaled aroma using standardized 9- point hedonic scale ranging from "extremely unpleasant" to "extremely pleasant"
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 25 Mar 2026.
- Individual participant dataSharing planned: Yes. Non-identifiable and non-sensitive individual participant data will be shared for academic and scientific purposes. The data will be available after the study is completed, for an indefinite period, through a virtual platform. The following will be shared: study design, statistical analysis plan, and consolidated research results. Access will be granted to interested researchers upon formal request, exclusively for secondary analyses, systematic reviews, or meta-analyses, with a commitment to ethical and academic use.
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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.
Mario F Peres, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavander essential oil, Peppermint essential oil and Lavandula angustifolia and Mentha Piperita in people with Migraine, run by University of Sao Paulo at 1 site in Brazil.
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: enrolling by invitation, as of the sponsor's last update on 25 Mar 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 Brazil. 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?
Pain pressure threshold (time frame: Baseline (pre- inhalation) and immediately after inhalation (within 15 minutes)). 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 25 Mar 2026.