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Набор скоро начнётся NCT06598904

The Effect of Aromatherapy for First Dental Visit Patients

Без фазы С лечением Dental 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: Aroma diffuser with single-note lavender essential oil, Aroma diffuser with single-note orange essential oil, Aroma diffuser with deionized water.
Кому может быть актуально
Состояния в реестре: Dental Anxiety. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial

Обзор

First dental visit experience is strongly correlated with dental anxiety, the aim of this protocol is to explore the efficacy of olfactory aromatherapy for the reduce of dental anxiety and pain in first-visit patient.

Вмешательства

  • Другое Aroma diffuser with single-note lavender essential oil
    In a space of 3\*4\*2.6 cubic meters, positioned 10 cm away from the patient, add 4-6 drops (each drop being 0.05 ml) of 100% concentration single-note lavender essential oil into the aroma diffuser reservoir containing 120 ml of water.
  • Другое Aroma diffuser with single-note orange essential oil
    In a space of 3\*4\*2.6 cubic meters, positioned 10 cm away from the patient, add 4-6 drops (each drop being 0.05 ml) of 100% concentration single-note orange essential oil into the aroma diffuser reservoir containing 120 ml of water.
  • Другое Aroma diffuser with deionized water
    In a space of 3\*4\*2.6 cubic meters, positioned 10 cm away from the patient, add 4-6 drops (each drop being 0.05 ml) of water into the aroma diffuser reservoir containing 120 ml of deionized water.

Первичные конечные точки

  • Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS) [Срок оценки: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.]
  • Pain scale - Visual Analog Scale (VAS) [Срок оценки: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.]
Вторичные конечные точки (5)
  • Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) [Срок оценки: 5 minutes before operation/ immediately after operation.]
  • Vital sign 1 - systolic blood pressure (SBP) [Срок оценки: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.]
  • Vital sign 2 - diastolic blood pressure (DBP) [Срок оценки: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.]
  • Vital sign 3 - heart rate (HR） [Срок оценки: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.]
  • Vital sign 4 - oxygen saturation (SpO2） [Срок оценки: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.]

Критерии участия

Критерии включения

  • Patients who never visited dental clinics before;
  • Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc;
  • Patients and their guardians who are able to understand the purpose of the study and volunteer to take part in the study;
  • Patients who are intellectually sufficient to complete the anxiety scale;
  • Be able to complete all assessments and follow-up during the study.

Критерии исключения

  • Patients who are allergic to the ingredients of the essential oils used in the experiment or to the materials used in the dental treatment;
  • Patients who underwent only an oral examination;
  • Patients with severe heart disease, hypertension, respiratory disease, or other systemic conditions that were not eligible for trial participation;
  • Pregnant or lactating women;
  • People with depressive symptoms, anxiety disorders or other mental illnesses that affect their mood state;
  • People who are using sedative or analgesic drugs;
  • Recent or current users of essential oils;
  • Any circumstances considered by the investigator to be inappropriate for participation in this study.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • West China Hospital of Stomatology SIchuan University — Чэнду

Идентификаторы

NCT: NCT06598904 · WCHS-CRSE-2024-128-R1-P

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗