Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction

Официальное название

"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"

Обзор

The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are: Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques? Does virtual reality distraction reduce pain perception during dental extraction? Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain. Participants will: Wear VR glasses to watch immersive 3D cartoons, or Watch 2D cartoons with headset, or Receive the conventional tell-show-do technique with verbal distraction. Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).

Вмешательства

• Устройство Virtual reality headset
  Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception.
• Поведенческое Audio-visual distraction with 2D cartoons
  Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.
• Поведенческое Tell-show-do with verbal distraction
  Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.

Первичные конечные точки

• Child Dental Anxiety (Self-Report) [Срок оценки: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)]
• Child Dental Anxiety (Observation-based Assessment) [Срок оценки: Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction]
• 3a: Physiological Monitoring - Pulse Rate [Срок оценки: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction]
• 3b: Physiological Monitoring - Oxygen Saturation (SpO₂) [Срок оценки: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction]

Вторичные конечные точки (2)

• Pain Perception (Self-Report) [Срок оценки: at the end of the procedure]
• Child Behavior (Observation) [Срок оценки: Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure]

Критерии участия

Критерии включения

• Children aged 6 to 10 years
• Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
• Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
• Children with NO previous exposure to invasive dental procedure
• No prior experience using VR glasses
• Requiring extraction of mandibular deciduous molar under local anesthesia

Критерии исключения

• ASA 3 and above
• Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
• Special needs ( intellectual and developmental)
• Children on psychotropic medication
• Children wearing glasses
• Presence of intra-oral swelling

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Oman · 2 центра

• Sultan Qaboos University Hospital - Dental & Maxillofacial Department — Muscat
• The Medical City of Military and Security Service (Dental Center-AlKhoudh ) — Muscat

Публикации

• Barros Padilha DX, Veiga NJ, Mello-Moura ACV, Nunes Correia P. Virtual reality and behaviour management in paediatric dentistry: a systematic review. BMC Oral Health. 2023 Dec 12;23(1):995. doi: 10.1186/s12903-023-03595-7. PMID 38087294
• Kasimoglu Y, Alpaycetin E, Ince G, Tuna Ince EB. Reduction of Dental Anxiety in Children Using Virtual Reality: A Randomised Controlled Trial. Eur J Paediatr Dent. 2025 Sep 1;26(3):185-191. doi: 10.23804/ejpd.2024.2109. Epub 2024 Oct 1. PMID 39465519
• Gomez-Polo C, Vilches AA, Ribas D, Castano-Seiquer A, Montero J. Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. J Clin Med. 2021 Jul 7;10(14):3019. doi: 10.3390/jcm10143019. PMID 34300185

Идентификаторы

NCT: NCT07693764 · PED-VR-2026-A · OMSBoard-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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