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临床试验/NCT07052019
NCT07052019尚未招募不适用

Pain Perception and Anxiety With Virtual Reality Distraction Versus Tell-Show-Do Technique in Restorative Treatment for Children With Molar Incisor Hypomineralization: A Pilot Crossover Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Pain perception

研究概览

简要总结

This pilot crossover randomized clinical trial aims to compare the effect of distraction using Virtual Reality (VR) versus the Tell-Show-Do (TSD) technique on pain perception and anxiety in children aged 6-12 with Molar Incisor Hypomineralization (MIH) undergoing restorative dental treatment.

详细描述

Molar Incisor Hypomineralization is a prevalent developmental condition affecting the enamel of first permanent molars and, occasionally, incisors. It presents significant clinical challenges due to the hypersensitivity and increased pain perception in affected teeth, which can make restorative treatment especially distressing for pediatric patients. Children with MIH are often apprehensive toward dental procedures, resulting in higher levels of dental anxiety that can impact their cooperation and the overall success of treatment. The management of pain and anxiety during restorative treatments is therefore crucial, particularly in this vulnerable population.

Behavioral management techniques, such as the Tell-Show-Do (TSD) approach, have been widely used in pediatric dentistry to alleviate anxiety and improve patient cooperation. However, recent advances in digital technology, particularly Virtual Reality (VR), offer novel, immersive forms of distraction that could enhance pain management by shifting the child's attention away from the dental procedure. VR distraction has shown promise in reducing anxiety and pain perception across various medical and dental settings, but its efficacy compared to traditional behavioral techniques, such as TSD, remains under-explored, especially in the context of MIH.

A recent systematic reviews of behavioral interventions in pediatric dentistry highlighted a lack of robust evidence regarding the effectiveness of VR as a distraction technique in dental settings, particularly in randomized controlled trials (RCTs). The reviews specifically called for more rigorous studies to directly compare VR with established techniques like TSD in managing dental anxiety and pain perception. Given this identified gap in the literature, this study aims to address these limitations by conducting a crossover randomized clinical trial to compare VR distraction with TSD in children with MIH undergoing restorative treatment. By examining both pain perception and anxiety levels, this study seeks to contribute valuable insights into the comparative effectiveness of VR and TSD, providing evidence-based recommendations for pediatric dental practitioners.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged between 6-12 years.
  • •Patients with two First Permanent molars diagnosed with MIH indicated for class I cavities.
  • •A cooperative and compliant patient/ parent.
  • •Patients not allergic to medicaments necessary to complete the procedure.
  • •Patients with no history of chronic systemic diseases.

排除标准

  • •MIH-affected molars require apexogenesis, apexification, regeneration or RCT.
  • •Non-restorable tooth.
  • •Previous restorative treatment.
  • •Periodontally affected.
  • •Children having systemic disease, an emotional behavioural or learning disorder.

研究组 & 干预措施

Arm A: Virtual Reality then Tell-Show-Do

Experimental

Children receive restorative treatment with Virtual Reality distraction during the first session, and Tell-Show-Do technique during the second session (after washout period).

干预措施: Virtual Reality Distraction (Device)

Arm A: Virtual Reality then Tell-Show-Do

Experimental

Children receive restorative treatment with Virtual Reality distraction during the first session, and Tell-Show-Do technique during the second session (after washout period).

干预措施: Tell-Show-Do Technique (Behavioral)

Arm B: Tell-Show-Do then Virtual Reality

Active Comparator

Children receive restorative treatment with Tell-Show-Do technique in the first session, and Virtual Reality distraction in the second session (after washout period).

干预措施: Virtual Reality Distraction (Device)

Arm B: Tell-Show-Do then Virtual Reality

Active Comparator

Children receive restorative treatment with Tell-Show-Do technique in the first session, and Virtual Reality distraction in the second session (after washout period).

干预措施: Tell-Show-Do Technique (Behavioral)

结局指标

主要结局

Pain perception

时间窗: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)

Tool: Wong Baker Faces Pain Rating Scale Unit: Score 0-10

次要结局

  • Anxiety level(Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure))
  • Heart Rate(Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes))
  • Oxygen Saturation(Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hagar Saleem Mojahed Abou-Musallam

Lecturer Assistant at Pediatric Dentistry Department

Cairo University

研究点 (1)

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