Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment

Официальное название

Effects of Immersive Virtual Reality on Pain, Anxiety, and Post-Procedural Experience in Pediatric Dental Treatment: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn whether immersive virtual reality (VR) reduces pain and anxiety in children aged 6-12 years during routine dental procedures. The main questions it aims to answer are: * Does VR distraction reduce self-reported pain and anxiety during dental treatment compared to standard behaviour guidance? * Does VR distraction improve children's post-procedural experience and willingness to return for future dental visits? Researchers will compare children using a VR headset during dental treatment to children receiving standard behaviour guidance techniques. Participants will: * Attend one routine dental appointment * Be randomly assigned to wear a VR headset or receive standard care during their procedure * Complete brief questionnaires about pain and anxiety before and after treatment * Receive a follow-up phone call 24-72 hours after the appointment

Вмешательства

• Устройство Immersive Virtual Reality Headset
  A commercially available immersive VR headset used as a non-pharmacological distraction tool during routine pediatric dental procedures. Children wear the headset throughout their treatment to engage with an interactive virtual environment designed to reduce pain and anxiety.
• Поведенческое Standard Behaviour Guidance
  Standard behaviour guidance techniques routinely used in pediatric dentistry, including tell-show-do, positive reinforcement, and distraction through verbal communication and a TV screen. No virtual reality headset is used.

Первичные конечные точки

• Self-Reported Pain During Dental Procedure Using Faces Pain Scale [Срок оценки: Baseline Pre-procedural and Immediately following the dental procedure (same day)]

Вторичные конечные точки (2)

• Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (U/L) baseline before any dental treatment and immediately following the dental procedure [Срок оценки: Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure. Both samples are collected on the same day, during the single dental appointment.]
• Physiological Stress Response (Heart Rate) [Срок оценки: Baseline (Before the procedure), during and Immediately following the dental procedure]

Критерии участия

Критерии включения

• Children aged 6 to 12 years
• Scheduled for a routine invasive dental procedure
• Accompanied by a parent or legal guardian
• Parent/guardian able to provide written informed consent

Критерии исключения

• Children with visual or hearing impairments that would prevent use of the VR headset
• Children with a history of motion sickness
• Children with severe cognitive or developmental delays that would prevent completion of study measures
• Children who have previously participated in this study
• Children requiring emergency dental treatment

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• UBC Graduate Pediatric Dental Clinic — Vancouver

Идентификаторы

NCT: NCT07636330 · H25-03739 · H25-03739

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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