Evaluation of Pain Thresholds in Migraine Patients After Inhalation of Essential Oils: a Randomized Clinical Trial

University of Sao Paulo

Status: Invitation-only

Conditions: Migraine

Treatments: Other: Lavandula angustifolia and Mentha Piperita; Other: Peppermint essential oil; Other: Lavander essential oil; Other: Coconut oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07493434

85802124.1.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

Lavander essential oil

Experimental group

Description:

Participants inhale lavander essential oil (Lavandula angustifolia) administered via inhalation for 15 minutes during the experimental session

Treatment:

Other: Lavander essential oil

Control (Coconut oil and distilled water)

Placebo Comparator group

Description:

Participants inhale a control solution consisting of coconut oil and distilled water, administered via inhalation for 15 minutes during the experimental session

Treatment:

Other: Coconut oil

Peppermint essential oil

Experimental group

Description:

Participants inhale peppermint essential oil (Mentha piperita) administered via inhalation for 15 minutes during the experimental session

Treatment:

Other: Peppermint essential oil

Peppemint and lavander essential oil

Experimental group

Description:

Participants inhale a combination of peppermint (Mentha piperita) an lavander (Lavandula angustifolia) essential oils administered via inhalation for 15 minutes during the experimental session

Treatment:

Other: Lavandula angustifolia and Mentha Piperita