- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07632547
Video-Enhanced Tell-Show-Do for Managing Dental Anxiety in Children
Reinforcing the Tell-Show-Do Technique With a Simulated Real-mouth Video to Manage Dental Anxiety in Children During Dental Treatment (A Randomized Controlled Trial)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Dental fear and anxiety in children are associated with several visual stimuli, such as the shape of the dental handpiece or saliva ejector, as well as painful procedures like local anaesthesia, which may create a barrier to receiving dental treatment. Many studies have explored various behaviour management techniques to reduce anxiety during treatment; however, few have investigated the effect of using a video simulation of the real oral environment to familiarise children with treatment steps and reinforce the phrases commonly used by the dentist. This study was designed to reassure children by using a video that demonstrates carious lesions and dental instruments, including the mirror, saliva ejector, handpiece, and syringe, and shows how they work inside the mouth in a child-friendly manner.
This research is a randomised controlled clinical trial in which participants were assigned to two groups based on the behaviour management technique used. Anxiety was assessed using three integrated measures: a self-reported anxiety scale, an observer-rated behaviour scale, and physiological indicators including oxygen saturation and heart rate. All measures were recorded before, during, and after treatment to provide a comprehensive evaluation of the intervention's effect on children's anxiety levels.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Rana Soleman
- Номер телефона: +963 934 966 599
- Электронная почта: drranasoliman66@gmail.com
Места учебы
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Damascus, Сирия
- Рекрутинг
- Damascus University
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Контакт:
- Rana Soliman
- Номер телефона: +963 934 966 599drranasoliman6
- Электронная почта: drranasoliman66@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Children aged 4-6 years, with or without previous dental experience.
- Children with a positive behavior rating according to the Frankl scale.
- Children with primary molars requiring conservative dental treatment.
Exclusion Criteria:
- Children with systemic or mental disorders.
- Children who received sedative or analgesic medications within the 3 hours prior to the dental visit.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Tell-Show-Do behavior management technique
Children in this group will receive restorative treatment with following the traditional TSD technique without any visual aids.
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This group received treatment guided by the Tell-Show-Do (TSD) method.
Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.'
After the explanation and instrument demonstration, restorative treatment was carried out.
The protocol excluded the use of any audiovisual aids.
All procedures involved conservative restoration of the mandibular primary molars
Другие имена:
Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation.
Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task.
The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal.
Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape.
These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation.
Each viewing was followed by a standardized verbal explanation before performing the clinical procedure.
All participants underwent conservative restorative treatment of the mandibular primary molars
Другие имена:
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Экспериментальный: Real-Oral Simulation Video-Assisted Tell-Show-Do Technique
Children in this group will receive restorative treatment with following the enhanced Tell-Show-Do technique with a video simulating the real oral environment
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This group received treatment guided by the Tell-Show-Do (TSD) method.
Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.'
After the explanation and instrument demonstration, restorative treatment was carried out.
The protocol excluded the use of any audiovisual aids.
All procedures involved conservative restoration of the mandibular primary molars
Другие имена:
Children in this group were managed using a video-assisted Tell-Show-Do (VATSD) approach incorporating real-oral simulation.
Each procedural step was preceded by a specific segment of a pre-recorded video tailored to the upcoming task.
The video featured a simulated intraoral environment where dental caries was personified by an animated 'tooth worm' to explain decay and its removal.
Consistent with conventional TSD, the video integrated child-friendly analogies: local anesthesia was introduced as 'sleepy juice'-depicting the 'tooth worm' falling asleep-and the rubber dam was shown as a barrier to prevent its escape.
These segments sequentially covered examination, anesthesia, rubber dam placement, and cavity preparation.
Each viewing was followed by a standardized verbal explanation before performing the clinical procedure.
All participants underwent conservative restorative treatment of the mandibular primary molars
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Heart Rate
Временное ограничение: during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.
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Assessment tool: Pulse oximeter Measurement unit: Beats per minute (bpm) Assessment time points: Heart rate was assessed during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment. |
during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.
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Facial Image Scale (FIS)
Временное ограничение: The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.
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Assessment tool: Facial Image Scale questionnaire Measurement unit: Ordinal score (1-5) Assessment time points: Facial Image Scale was assessed during a single dental treatment visit at baseline and during treatment. |
The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Oxygen Saturation (SpO₂)
Временное ограничение: Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.
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Assessment tool: Pulse oximeter Measurement unit: Percentage (%) Assessment time points: Oxygen saturation was measured using a pulse oximeter and recorded during a single dental treatment visit at baseline, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during dental treatment. |
Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Chaza Kouchaji, Damascus University
Публикации и полезные ссылки
Общие публикации
- Liu Y, Gu Z, Wang Y, Wu Q, Chen V, Xu X, Zhou X. Effect of audiovisual distraction on the management of dental anxiety in children: A systematic review. Int J Paediatr Dent. 2019 Jan;29(1):14-21. doi: 10.1111/ipd.12430. Epub 2018 Oct 26.
- Abbasi H, Saqib M, Jouhar R, Lal A, Ahmed N, Ahmed MA, Alam MK. The Efficacy of Little Lovely Dentist, Dental Song, and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Paediatric Patients: A Clinical Trial. Biomed Res Int. 2021 May 23;2021:1119710. doi: 10.1155/2021/1119710. eCollection 2021.
- Khandelwal D, Kalra N, Tyagi R, Khatri A, Gupta K. Control of Anxiety in Pediatric Patients using "Tell Show Do" Method and Audiovisual Distraction. J Contemp Dent Pract. 2018 Sep 1;19(9):1058-1064.
- Seligman LD, Hovey JD, Chacon K, Ollendick TH. Dental anxiety: An understudied problem in youth. Clin Psychol Rev. 2017 Jul;55:25-40. doi: 10.1016/j.cpr.2017.04.004. Epub 2017 Apr 19.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UDDS-Pedo-03-2026
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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