Набор по приглашению NCT07493434

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

Без фазы С лечением Migraine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Lavander essential oil, Peppermint essential oil, Lavandula angustifolia and Mentha Piperita, Coconut oil.
Кому может быть актуально: Состояния в реестре: Migraine. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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.
Другое 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.
Другое 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.
Другое 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.

Первичные конечные точки

Pain pressure threshold [Срок оценки: Baseline (pre- inhalation) and immediately after inhalation (within 15 minutes)]

Вторичные конечные точки (1)

Hedonic perception of the aroma [Срок оценки: Participants will report the perceveid pleasantness of inhaled aroma using standardized 9- point hedonic scale ranging from "extremely unpleasant" to "extremely pleasant"]

Критерии участия

Критерии включения

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