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Идёт набор NCT07245030

Effectiveness of Virtual Reality vs Show-Do Technique on Dental Anxiety in Children With Hearing Impairment

Без фазы С лечением Dental Anxiety of Hearing Impairment

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, show-do technique.
Кому может быть актуально
Состояния в реестре: Dental Anxiety of Hearing Impairment. 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
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Официальное название

A Comparative Evaluation of the Effectiveness of Virtual Reality Eyewear vs Show-Do Technique on Dental Anxiety and Behavior in a Group of Children With Different Levels of Hearing Impairment During Dental Prophylaxis Procedure: A Randomized Controlled Trial

Обзор

This randomized controlled clinical trial aims to compare the effectiveness of virtual reality (VR) eyewear used as a distraction method in combination with the Show-Do (SD) technique versus the traditional Show-Do technique alone in managing dental anxiety and improving behavioral responses among Egyptian children with different levels of hearing impairment during a dental prophylaxis procedure. The study will evaluate dental anxiety using pulse rate and the PJS-Pictorial Scale, while behavior will be assessed using the Frankl Behavior Rating Scale. The trial seeks to provide evidence-based guidance on the implementation of VR technology as an adjunctive non-pharmacological tool for children with communication barriers in pediatric dentistry.

Подробное описание

Dental anxiety is a common barrier to effective dental care in pediatric patients, particularly in children with special health care needs such as hearing impairment. Communication limitations can increase anxiety and reduce cooperation, complicating dental treatment delivery. Traditional non-pharmacological techniques such as the Show-Do (SD) method are widely used to reduce anxiety by familiarizing children with dental procedures through demonstration and gradual exposure. However, their effectiveness may be limited in children with hearing impairments, who may not fully understand auditory or verbal explanations.

Virtual reality (VR) eyewear represents an innovative behavioral management tool that immerses the child in an interactive and engaging virtual environment, thereby diverting attention away from the dental procedure and reducing anxiety. Evidence from recent systematic reviews indicates that VR interventions can significantly decrease pain perception and anxiety in pediatric medical and dental settings, yet studies specifically targeting children with hearing impairment remain scarce.

This randomized controlled trial will be conducted at the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Participants will include children with varying levels of hearing impairment requiring dental prophylaxis. Eligible participants will be randomly assigned in a 1:1 ratio to either the control group (Show-Do technique only) or the intervention group (Show-Do technique combined with VR eyewear). Dental anxiety will be measured objectively using pulse oximetry and subjectively using the PJS-Pictorial Scale, while behavior will be assessed using the Frankl Behavior Rating Scale.

The study is designed to generate clinical evidence regarding the efficacy of integrating VR eyewear with conventional behavioral management methods for children with communication challenges. The results are expected to contribute to the development of inclusive, non-pharmacological strategies to manage dental anxiety and improve cooperation among pediatric patients with hearing impairments, ultimately enhancing patient-centered care in pediatric dentistry.

Вмешательства

  • Устройство virtual reality distraction
    children wear virtual reality glasses during dental prophylaxis procedure to reduce dental anxiety and enhance patient's behavior.
  • Поведенческое show-do technique
    conventional behavioral technique where the dentist shows and then perform the procedure to reduce anxiety and build cooperation.

Первичные конечные точки

  • anxiety level (objective) [Срок оценки: baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)]
Вторичные конечные точки (2)
  • anxiety level (subjective) [Срок оценки: immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)]
  • behavior assessment [Срок оценки: immediately before treatment (baseline), during treatment (real-time), and immediately after treatment (post-procedure)]

Критерии участия

Критерии включения

  • Children with moderate to severe Hearing impairment.
  • Children require dental prophylaxis.
  • Apparently, Health Children.

Критерии исключения

  • Children with severe cognitive impairment or developmental disorders.
  • Children who are unable or unwilling to cooperate with the study protocol or assessment.
  • Children with complicated systemic diseases.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Египет · 2 центра
  • October University for Modern Sciences and Arts — Giza
  • October University for Modern Sciences and Arts — Giza

Идентификаторы

NCT: NCT07245030 · Tamara MSA University

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗