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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavander essential oil | Experimental | Participants inhale lavander essential oil (Lavandula angustifolia) administered via inhalation for 15 minutes during the experimental session |
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| 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 |
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| Peppermint essential oil | Experimental | Participants inhale peppermint essential oil (Mentha piperita) administered via inhalation for 15 minutes during the experimental session |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavander essential oil | Other | Lavander essential oil (Lavandula angustifolia) administered by inhalation. Six drops are applied via individual inhaler wick for inhalation during a 15- minute experimental session. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Hedonic perception of the aroma | Immediately after inhalatioan (within 30 minutes) | Participants will report the perceveid pleasantness of inhaled aroma using standardized 9- point hedonic scale ranging from "extremely unpleasant" to "extremely pleasant" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario F Peres, MD, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intitute of Psychiatry- Hospital das ClÃnicas, University of São Paulo | São Paulo | São Paulo | 11 | Brazil |
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.
The data will be available after the study is completed
Access will be granted to interested researchers upon formal request
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This is an intervencional, parallel, randomized, double-blind, placebo-controlled clinical trial
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| Peppermint essential oil | Other | Peppermint essential oil (Mentha piperita) administered by inhalation. Six drops are applied via inhaler wick for inhalation during a 15-minute experimental session. |
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| Lavandula angustifolia and Mentha Piperita | Other | 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. |
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| Coconut oil | Other | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000074263 | Coconut Oil |
| ID | Term |
|---|---|
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
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