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Идёт набор NCT07113080

Assessing the Efficacy of Lemongrass and Lavender Aromatherapy in Reducing Dental Anxiety and Pain Associated With Local Anesthetic Injections in Pediatric Dental Patients

Фаза IV С лечением Dental Fear and Anxiety

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: lavender essential oil inhaled using face mask, lemongrass essential oil inhaled using face mask.
Кому может быть актуально
Состояния в реестре: Dental Fear and Anxiety. Базовые параметры: 7 лет — 11 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Lemongrass and Lavender Aromatherapy on Dental Anxiety and Pain Perception in Children Undergoing Local Anesthetic Administration: A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to evaluate whether aromatherapy using lemongrass or lavender essential oils can reduce dental anxiety and pain perception in children aged 7-11 years undergoing local anesthetic administration in a pediatric dental setting. The main questions it aims to answer are: Does lemongrass or lavender aromatherapy reduce anxiety levels, as measured by salivary cortisol, in children receiving local anesthesia? Does aromatherapy influence pain perception and physiological stress (heart rate) during the procedure? Researchers will compare a lavender aromatherapy group, a lemongrass aromatherapy group, and a control group without aromatherapy to see if the essential oils have a calming effect that reduces anxiety and pain compared to no intervention. Participants will: Inhale either lavender, lemongrass, or no essential oil (control) for two minutes via nebulizer. Undergo local anesthesia administration for a dental procedure. Provide unstimulated and stimulated saliva samples before and after the procedure for cortisol analysis. Report their pain level using the Wong-Baker Faces Pain Rating Scale. Have their heart rate measured before and after the procedure using a finger-type pulse oximeter.

Подробное описание

Dental anxiety is a common behavioral challenge in pediatric dentistry and can significantly influence the quality of dental care, potentially leading to avoidance of necessary treatments. One of the most anxiety-inducing procedures is the administration of local anesthesia. Excessive fear and pain perception can negatively impact the child's dental experience and long-term oral health behavior.

Aromatherapy, a non-pharmacological method utilizing essential oils from plants, has shown potential in reducing anxiety and promoting relaxation. Lavender essential oil (Lavandula angustifolia) has been extensively studied for its calming and anxiolytic properties in children and adults. Lemongrass (Cymbopogon citratus) also contains bioactive compounds believed to have similar relaxing effects, though its use in pediatric dental settings has not been adequately evaluated.

This randomized clinical trial aims to investigate the effects of lavender and lemongrass aromatherapy on anxiety levels and pain perception in children aged 7-11 years undergoing local anesthetic administration at the pediatric dentistry department, Faculty of Dentistry, Ain Shams University.

Forty-eight medically free children, with no prior dental visits and who fall within Frankl behavioral rating scale levels 3 or 4, will be randomly assigned to one of three groups:

Lavender aromatherapy group

Lemongrass aromatherapy group

Control group (no aromatherapy)

Children in the intervention groups will inhale either lavender or lemongrass essential oil via a nebulizer for 2 minutes prior to receiving local anesthesia. The control group will receive standard care with no aromatherapy. All local anesthetic injections will be performed using 4% articaine with 1:100,000 epinephrine after applying topical anesthesia to dry mucosa.

To objectively assess anxiety levels, salivary cortisol will be collected before and after the procedure using an unstimulated/stimulated saliva method. Cortisol concentrations will be analyzed using a commercial ELISA kit. Pain perception will be evaluated immediately after the procedure using the Wong-Baker Faces Pain Rating Scale - a validated self-reported tool for children. Heart rate will also be recorded before and after treatment using a finger-type pulse oximeter as a physiological stress marker.

The primary objective is to determine whether either essential oil significantly reduces anxiety levels, as evidenced by changes in salivary cortisol. Secondary outcomes include differences in reported pain and heart rate between groups. The study uses simple randomization with opaque envelope allocation concealment and blinding of outcome assessors (statistician and lab technician). Due to the nature of the intervention, operator and participant blinding is not possible.

This study may offer a practical, non-invasive adjunctive method to manage dental anxiety and pain in children, improving patient cooperation and long-term dental health outcomes.

Вмешательства

  • Препарат lavender essential oil inhaled using face mask
    participants will inhale lavender essential oil via nebulizer before local anesthesia administration
  • Препарат lemongrass essential oil inhaled using face mask
    participants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration

Первичные конечные точки

  • anxiety level [Срок оценки: salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure]
Вторичные конечные точки (2)
  • pain perception [Срок оценки: immediately after local anesthetic administration]
  • physiological changes(heart rate) [Срок оценки: as baseline and 1 minute after local anesthetic administration]

Критерии участия

Критерии включения

  • children aged 7-11 years
  • medically free
  • children category 3 or 4 according to Frankle behavior rating scale
  • patients who approve of signing informed consent and give child assent
  • children with at least one vital primary molar with deep carious lesion

Критерии исключения

  • children with a previous dental visit
  • children suffering from any upper or lower respiratory tract problems
  • children with any history of allergy children who currently use any medications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • pediatric dentistry and dental public health department, faculty of dentistry, Ain shams u — Cairo

Идентификаторы

NCT: NCT07113080 · PED-24-13M

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗