Evaluation of Pain Thresholds in Migraine Patients After Inhalation of Essential Oils: a Randomized Clinical Trial
1 other identifier
interventional
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2025
CompletedFirst Submitted
Initial submission to the registry
March 14, 2026
CompletedFirst Posted
Study publicly available on registry
March 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 25, 2026
March 1, 2026
2 years
March 14, 2026
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (pre- inhalation) and immediately after inhalation (within 15 minutes)
Secondary Outcomes (1)
Hedonic perception of the aroma
Participants will report the perceveid pleasantness of inhaled aroma using standardized 9- point hedonic scale ranging from "extremely unpleasant" to "extremely pleasant"
Study Arms (4)
Lavander essential oil
EXPERIMENTALParticipants inhale lavander essential oil (Lavandula angustifolia) administered via inhalation for 15 minutes during the experimental session
Control (Coconut oil and distilled water)
PLACEBO COMPARATORParticipants inhale a control solution consisting of coconut oil and distilled water, administered via inhalation for 15 minutes during the experimental session
Peppermint essential oil
EXPERIMENTALParticipants inhale peppermint essential oil (Mentha piperita) administered via inhalation for 15 minutes during the experimental session
Peppemint and lavander essential oil
EXPERIMENTALParticipants inhale a combination of peppermint (Mentha piperita) an lavander (Lavandula angustifolia) essential oils administered via inhalation for 15 minutes during the experimental session
Interventions
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 oil (Mentha piperita) administered by inhalation. Six drops are applied via inhaler wick for inhalation during a 15-minute experimental session.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intitute of Psychiatry- Hospital das Clínicas, University of São Paulo
São Paulo, São Paulo, 11, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario F Peres, MD, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in orofacial pain
Study Record Dates
First Submitted
March 14, 2026
First Posted
March 25, 2026
Study Start
March 13, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- The data will be available after the study is completed
- Access Criteria
- Access will be granted to interested researchers upon formal request
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.