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Набор по приглашению NCT07167394

The Effect of Virtual Reality Glasses on Pain Perception

Без фазы С лечением Virtual Reality 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: Interactive Virtual Reality Guidance with Restorative Dental Treatment, Tell-Show-Do Guidance with Restorative Dental Treatment.
Кому может быть актуально
Состояния в реестре: Virtual Reality, Dental Anxiety. Базовые параметры: 6 лет — 10 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of Presenting Restorative Dental Treatments in a Game Format Using Virtual Reality Glasses on Anxiety and Pain Perception in Children

Обзор

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear of pain, negative remarks about dentists they might have heard from others, the sounds of dental equipment, bright lights, or even their parents' anxious demeanor. Addressing these fears and implementing strategies to reduce anxiety and alter pain perception can make dental visits smoother. Such measures also positively influence children's oral health, dental development, future dental experiences, eating habits, general health, and self-confidence. On the contrary, if the first dental experience is associated with pain and anxiety, this can condition children-particularly those who are more sensitive-to develop persistent dental anxiety. In severe cases, repeated exposure to dental procedures or clinic visits may evoke psychological trauma, leading to multifaceted negative consequences in the future. This study aims to compare the effects of an individualized game-based simulation presented through virtual reality (VR) glasses versus the conventional tell-show-do (TSD) technique on children's pain intensity and anxiety during dental procedures. A total of 88 children, determined through power analysis, aged 6-10 years and attending their first dental visit, will be randomly assigned to two groups using odd-even numbering. The study group (odd numbers) will receive restorative treatment accompanied by a VR-based game, while the other group (even numbers) will undergo treatment using the TSD technique. In the VR group, children will experience a specially designed interactive game that explains the treatment process step-by-step. The game aims to redirect attention away from discomfort using motivational elements such as visual-auditory stimuli, narrative-driven stages, and the goal of progressing through the game. Behaviors that support cooperation will be embedded as in-game tasks to improve compliance and reduce anxiety. In the other group, behavior management will be provided using the tell-show-do method. This includes explaining procedures using child-friendly language (tell), demonstrating non-threatening aspects of the instruments and environment (show), and performing the procedures accordingly (do). After informed consent is obtained, the treating dentist will select teeth based on clinical and radiographic criteria. Dento-alveolar images will be reviewed using VR glasses and explained to the parent, who will also wear VR glasses for an immersive consultation experience. A caries detection tool powered by artificial intelligence will support diagnosis. Treatments will be performed on the lower primary molars with mesio-occlusal or disto-occlusal caries not involving the pulp. Pain perception and anxiety will be evaluated using psychometric scales (SCARED, CFSS-DS, Wong-Baker, STAIC) and physiological measurements (pulse oximeter, heart rate) at standardized intervals: before, during, and after treatment. It is hypothesized that the VR-based game will result in lower anxiety and pain perception, greater cooperation, and more positive dental experiences compared to the tell-show-do method.

Подробное описание

Positive experiences during a child's first dental visit contribute to the development of both acute and long-term positive attitudes toward dentists and dental treatments. However, some children may find dental visits stressful or frightening due to several factors, including being in an unfamiliar environment, fear of pain, negative remarks about dentists they might have heard from others, the sounds of dental equipment, bright lights, or even their parents' anxious demeanor. Addressing these fears and implementing strategies to reduce anxiety and alter pain perception can make dental visits smoother. Such measures also positively influence children's oral health, dental development, future dental experiences, eating habits, general health, and self-confidence.

On the contrary, if the first dental experience is associated with pain and anxiety, this can condition children-particularly those who are more sensitive-to develop persistent dental anxiety. In severe cases, repeated exposure to dental procedures or clinic visits may evoke psychological trauma, leading to multifaceted negative consequences in the future.

This study aims to compare the effects of an individualized game-based simulation presented through virtual reality (VR) glasses versus the conventional tell-show-do (TSD) technique on children's pain intensity and anxiety during dental procedures.

A total of 88 children, determined through power analysis, aged 6-10 years and attending their first dental visit, will be randomly assigned to two groups using odd-even numbering. The study group (odd numbers) will receive restorative treatment accompanied by a VR-based game, while the other group (even numbers) will undergo treatment using the TSD technique.

In the VR group, children will experience a specially designed interactive game that explains the treatment process step-by-step. The game aims to redirect attention away from discomfort using motivational elements such as visual-auditory stimuli, narrative-driven stages, and the goal of progressing through the game. Behaviors that support cooperation will be embedded as in-game tasks to improve compliance and reduce anxiety.

In the other group, behavior management will be provided using the tell-show-do method. This includes explaining procedures using child-friendly language (tell), demonstrating non-threatening aspects of the instruments and environment (show), and performing the procedures accordingly (do).

After informed consent is obtained, the treating dentist will select teeth based on clinical and radiographic criteria. Dento-alveolar images will be reviewed using VR glasses and explained to the parent, who will also wear VR glasses for an immersive consultation experience. A caries detection tool powered by artificial intelligence will support diagnosis.

Treatments will be performed on the lower primary molars with mesio-occlusal or disto-occlusal caries not involving the pulp.

To ensure the exclusion of children with underlying psychopathologies, participants will first be screened using the Child Behavior Checklist (CBCL) and the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). Only those without psychiatric indications will be included in the study.

Pain perception and anxiety will be evaluated using psychometric scales (SCARED, CFSS-DS, Wong-Baker, STAIC) and physiological measurements (pulse oximeter, heart rate) at four standardized intervals: before treatment, during anesthesia administration, during the procedure, and after treatment.

It is hypothesized that the VR-based game will result in lower anxiety and pain perception, greater cooperation, and more positive dental experiences compared to the tell-show-do method.

Вмешательства

  • Процедура Interactive Virtual Reality Guidance with Restorative Dental Treatment
    Participants in this group will undergo a standardized restorative dental procedure on mandibular primary molars involving local anesthesia, caries excavation, and compomer restoration. Prior to the treatment, children will wear a virtual reality (VR) headset through which they will experience an interactive, animated educational game. The VR content simulates the treatment steps-including sitting in the chair, receiving local anesthesia, caries removal, filling, and polishing-using engaging ch
  • Процедура Tell-Show-Do Guidance with Restorative Dental Treatment
    Participants in this group will also receive a standardized restorative dental procedure identical to the VR group, including local anesthesia, caries removal, and compomer filling of mandibular primary molars. Behavioral preparation will be conducted using the conventional Tell-Show-Do technique. The clinician will verbally explain each step, demonstrate the procedure using visual and tactile tools in a child-friendly manner, and then proceed with the actual intervention. This method aims to re

Первичные конечные точки

  • State-Trait Anxiety Inventory for Children - Dental Version [Срок оценки: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.]
  • SCARED (Screen for Child Anxiety Related Emotional Disorders) [Срок оценки: Time Frame: Baseline (before the treatment) and within 20 minutes after the end of the restorative treatment for each arm.]
  • Pulse Rate Monitoring via Pulse Oximeter [Срок оценки: T1: Baseline - before the patient is seated in the dental chair. T2: During local anesthesia administration. T3: During the restorative treatment. T4: Within 5 minutes after completion of the treatment.]
  • Wong-Baker Faces Pain Rating Scale [Срок оценки: Time Frame: After local anesthesia administration and within 20 minutes after the end of the restorative treatment for each arm.]
  • Children's Fear Survey Schedule - Dental Subscale (CFSS-DS) [Срок оценки: Time Frame: Within 20 minutes after the end of the restorative treatment for each arm.]

Критерии участия

Критерии включения

  • Children aged 6 to 10 years
  • No previous dental treatment history
  • No systemic or chronic medical conditions
  • No mental retardation
  • No psychiatric pathology based on CBCL, K-SADS-PL-T, and SCARED (SCARED score <25)
  • Presence of dentin caries on mandibular molars (mesio-occlusal or disto-occlusal)
  • Signed informed consent by parent/Guardian

Критерии исключения

  • Prior dental treatment experience
  • SCARED score ≥25
  • Diagnosed psychological or developmental disorders
  • Acute dental pain or irreversible pulp involvement
  • Decline to sign informed consent

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

Turkey (Türkiye) · 1 центр
  • Ankara University, Faculty of Dentistry, Pediatric Dentistry Dept — Ankara

Идентификаторы

NCT: NCT07167394 · 2023.18/2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗