Virtual Reality Audiovisual Distraction During Pediatric Dental Treatment (VR-DENT-PED)
Audiovisual Distraction Using Virtual Reality Glasses for Reducing Anxiety During Pediatric Dental Treatment: A Prospective Non-Randomized Controlled Clinical Study
Dental anxiety is common in children and may interfere with cooperation during dental treatment. Audiovisual distraction using virtual reality glasses may help redirect attention away from dental stimuli and improve the patient experience.
This completed prospective non-randomized controlled clinical study evaluated the effect of virtual reality audiovisual distraction on anxiety-related variables in pediatric patients undergoing dental treatment at the Dental Clinic of Universidad Europea de Madrid. Participants received either standard dental care without audiovisual distraction or standard dental care while using virtual reality glasses during the procedure.
Dental anxiety was assessed using the Modified Facial Image Scale. Heart rate and peripheral oxygen saturation were recorded using pediatric pulse oximetry. Behavioral response was assessed using the FLACC scale. Measurements were taken before, during, and after dental treatment; in the virtual reality group, additional measurements were collected while the child was using the glasses and after the glasses were removed. This record was submitted after completion of participant enrollment and data collection for retrospective public registration.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study was conducted in pediatric patients aged 6 to 17 years who attended the Dental Clinic of Universidad Europea de Madrid and required dental treatment. Patients were assigned to one of two clinical conditions: standard dental care without audiovisual distraction or standard dental care with audiovisual distraction using virtual reality glasses. The virtual reality glasses reproduced narrative audiovisual content intended to distract the child from the dental procedure and reduce anxiety-related responses.
The dental procedures included prophylaxis, topical fluoride application, pit and fissure sealants, and restorative dental treatment. All dental procedures were performed by dental students under direct supervision of calibrated clinical instructors with experience in pediatric dentistry. Operators and investigators received specific training in the use of the anxiety and behavioral assessment scales and in the recording of physiological variables.
The primary outcome was dental anxiety assessed using the Modified Facial Image Scale. Secondary outcomes included heart rate, peripheral oxygen saturation, and behavioral response using the FLACC scale. Measurements were recorded at predefined time points during the dental visit. The final analytical sample consisted of 79 participants; however, actual enrollment was 81 because two participants in the virtual reality group discontinued the intervention by removing the glasses during treatment.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Madrid
-
Madrid, Madrid, Испания, 28003
- Policlinica Universitaria UEM
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Pediatric patients aged 6 to 17 years.
- Patients attending the Dental Clinic of Universidad Europea de Madrid for dental treatment.
- Written informed consent provided by parents or legal guardians.
- Child assent/information provided according to age and level of understanding.
Exclusion Criteria:
- Absence of written informed consent from parents or legal guardians.
- Visual or auditory impairment preventing the use of audiovisual distraction.
- Medical conditions contraindicating dental treatment in the clinical setting.
- Behavioral management not feasible in the clinical setting.
- In the virtual reality group, discontinuation of the intervention by removing the glasses during treatment.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Virtual Reality Audiovisual Distraction
Participants received standard pediatric dental treatment while wearing virtual reality glasses that reproduced narrative audiovisual content during the procedure. |
Use of virtual reality glasses during pediatric dental treatment to provide immersive audiovisual distraction and redirect attention away from dental stimuli. |
|
Без вмешательства: Standard Dental Care
Participants received standard pediatric dental treatment under usual clinical conditions without additional audiovisual distraction. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in dental anxiety assessed using the Modified Facial Image Scale
Временное ограничение: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
Dental anxiety was measured using the Modified Facial Image Scale, a child-friendly facial scale used to assess self-perceived emotional state in pediatric dental settings. Higher scores indicate greater anxiety or a more negative emotional response. |
Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in heart rate during pediatric dental treatment
Временное ограничение: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
Heart rate was recorded using pediatric pulse oximetry and expressed in beats per minute. |
Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
|
Change in peripheral oxygen saturation during pediatric dental treatment
Временное ограничение: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
Peripheral oxygen saturation was recorded using pediatric pulse oximetry and expressed as SpO2 percentage. |
Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
|
Behavioral response assessed using the FLACC scale
Временное ограничение: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
Behavioral response was assessed using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. The total score ranges from 0 to 10, with higher scores indicating greater behavioral distress or discomfort. |
Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CIPI-22-306
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Individual participant data will not be made publicly available because the study involved pediatric participants and the dataset contains potentially sensitive clinical information. De-identified aggregated data or additional information may be available from the corresponding author upon reasonable request and subject to institutional and ethical restrictions.
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