Evaluation of Pain Thresholds in Migraine Patients After Inhalation of Essential Oils: a Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lavander essential oil, Peppermint essential oil, Lavandula angustifolia and Mentha Piperita, Coconut oil.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Lavander essential oil
Lavander essential oil (Lavandula angustifolia) administered by inhalation. Six drops are applied via individual inhaler wick for inhalation during a 15- minute experimental session. - Other Peppermint essential oil
Peppermint essential oil (Mentha piperita) administered by inhalation. Six drops are applied via inhaler wick for inhalation during a 15-minute experimental session. - Other Lavandula angustifolia and Mentha Piperita
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. - Other Coconut oil
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.
Primary outcome measures
- Pain pressure threshold [Time frame: Baseline (pre- inhalation) and immediately after inhalation (within 15 minutes)]
Secondary outcome measures (1)
- 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"]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Brazil · 1 center
- Intitute of Psychiatry- Hospital das Clínicas, University of São Paulo — São Paulo
Identifiers
NCT: NCT07493434 · 85802124.1.0000.0068