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Enrolling by Invitation

NCT Number: NCT07493434

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intitute of Psychiatry- Hospital das Clínicas, University of São Paulo

São Paulo, 11, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Pain pressure threshold

    Time frame: 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 outcomes

  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"

    Immediately after inhalatioan (within 30 minutes)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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