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Набор скоро начнётся NCT07052019

Pain Perception and Anxiety With Virtual Reality vs Tell-Show-Do in Children With MIH

Без фазы С лечением Molar Incisor Hypomineralization

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: Virtual Reality Distraction, Tell-Show-Do Technique.
Кому может быть актуально
Состояния в реестре: Molar Incisor Hypomineralization. Базовые параметры: 6 лет — 12 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

Pain Perception and Anxiety With Virtual Reality Distraction Versus Tell-Show-Do Technique in Restorative Treatment for Children With Molar Incisor Hypomineralization: A Pilot Crossover Randomized Clinical Trial

Обзор

This pilot crossover randomized clinical trial aims to compare the effect of distraction using Virtual Reality (VR) versus the Tell-Show-Do (TSD) technique on pain perception and anxiety in children aged 6-12 with Molar Incisor Hypomineralization (MIH) undergoing restorative dental treatment.

Подробное описание

Molar Incisor Hypomineralization is a prevalent developmental condition affecting the enamel of first permanent molars and, occasionally, incisors. It presents significant clinical challenges due to the hypersensitivity and increased pain perception in affected teeth, which can make restorative treatment especially distressing for pediatric patients. Children with MIH are often apprehensive toward dental procedures, resulting in higher levels of dental anxiety that can impact their cooperation and the overall success of treatment. The management of pain and anxiety during restorative treatments is therefore crucial, particularly in this vulnerable population.

Behavioral management techniques, such as the Tell-Show-Do (TSD) approach, have been widely used in pediatric dentistry to alleviate anxiety and improve patient cooperation. However, recent advances in digital technology, particularly Virtual Reality (VR), offer novel, immersive forms of distraction that could enhance pain management by shifting the child's attention away from the dental procedure. VR distraction has shown promise in reducing anxiety and pain perception across various medical and dental settings, but its efficacy compared to traditional behavioral techniques, such as TSD, remains under-explored, especially in the context of MIH.

A recent systematic reviews of behavioral interventions in pediatric dentistry highlighted a lack of robust evidence regarding the effectiveness of VR as a distraction technique in dental settings, particularly in randomized controlled trials (RCTs). The reviews specifically called for more rigorous studies to directly compare VR with established techniques like TSD in managing dental anxiety and pain perception. Given this identified gap in the literature, this study aims to address these limitations by conducting a crossover randomized clinical trial to compare VR distraction with TSD in children with MIH undergoing restorative treatment. By examining both pain perception and anxiety levels, this study seeks to contribute valuable insights into the comparative effectiveness of VR and TSD, providing evidence-based recommendations for pediatric dental practitioners.

Вмешательства

  • Устройство Virtual Reality Distraction
    Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety.
  • Поведенческое Tell-Show-Do Technique
    Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.

Первичные конечные точки

  • Pain perception [Срок оценки: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)]
Вторичные конечные точки (3)
  • Anxiety level [Срок оценки: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)]
  • Heart Rate [Срок оценки: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)]
  • Oxygen Saturation [Срок оценки: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)]

Критерии участия

Критерии включения

  • Children aged between 6-12 years.
  • Patients with two First Permanent molars diagnosed with MIH indicated for class I cavities.
  • A cooperative and compliant patient/ parent.
  • Patients not allergic to medicaments necessary to complete the procedure.
  • Patients with no history of chronic systemic diseases.

Критерии исключения

  • MIH-affected molars require apexogenesis, apexification, regeneration or RCT.
  • Non-restorable tooth.
  • Previous restorative treatment.
  • Periodontally affected.
  • Children having systemic disease, an emotional behavioural or learning disorder.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • faculty of dentistry, Cairo university — Giza

Идентификаторы

NCT: NCT07052019 · U Cairo Hagar

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗