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Not yet recruiting NCT07636330

Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment

No phase Interventional Dental Anxiety in Children Pain

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: Immersive Virtual Reality Headset, Standard Behaviour Guidance.
Who it may be relevant to
Registry conditions: Dental Anxiety in Children, Pain. 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
Canada
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

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

Overview

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

Interventions

  • Device 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.
  • Behavioral 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.

Primary outcome measures

  • Self-Reported Pain During Dental Procedure Using Faces Pain Scale [Time frame: Baseline Pre-procedural and Immediately following the dental procedure (same day)]
Secondary outcome measures (2)
  • Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (U/L) baseline before any dental treatment and immediately following the dental procedure [Time frame: 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) [Time frame: Baseline (Before the procedure), during and Immediately following the dental procedure]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • UBC Graduate Pediatric Dental Clinic — Vancouver

Identifiers

NCT: NCT07636330 · H25-03739 · H25-03739

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗