Migraine
Conditions
Keywords
migraine, pain pressure threshold, volatile oils
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.
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
OTHERLavander 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.
Peppermint essential oil (Mentha piperita) administered by inhalation. Six drops are applied via inhaler wick for inhalation during a 15-minute experimental session.
OTHERLavandula 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.
OTHERCoconut 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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is an intervencional, parallel, randomized, double-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain pressure threshold | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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" | Immediately after inhalatioan (within 30 minutes) |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORMario F Peres, MD, PhD
University of Sao Paulo
Outcome results
None listed