Pain Perception and Anxiety With Virtual Reality vs Tell-Show-Do in Children With MIH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality Distraction, Tell-Show-Do Technique.
- Who it may be relevant to
- Registry conditions: Molar Incisor Hypomineralization. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Device Virtual Reality Distraction
Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety. - Behavioral Tell-Show-Do Technique
Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.
Primary outcome measures
- Pain perception [Time frame: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)]
Secondary outcome measures (3)
- Anxiety level [Time frame: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)]
- Heart Rate [Time frame: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)]
- Oxygen Saturation [Time frame: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- faculty of dentistry, Cairo university — Giza
Identifiers
NCT: NCT07052019 · U Cairo Hagar