Dental Anxiety in Children, Pain
Conditions
Keywords
Distraction, Virtual reality, Pediatric Dentistry, Dental Anxiety, Procedural Pain
Brief summary
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
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Pain During Dental Procedure Using Faces Pain Scale | Baseline Pre-procedural and Immediately following the dental procedure (same day) | Child self-reported pain assessed using the Faces Pain Scale (0-10 where 10 is the maximum pain felt): The child is asked to point to the Faces picture that reflect the pain level that they are feeling. 0= Relaxed and comfortable; 2-4= Mild discomfort; 6-8= Moderate pain; 10= Severe pain or discomfort Baseline pre-procedural and immediately following the dental procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (U/L) baseline before any dental treatment and immediately following the dental procedure | 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. | Using a swab to collect for a full 60-90 seconds by resting the swab inside the mouth, or collect in intervals by re-introducing the swab into the mouth as needed, until the lower third of the swab is saturated (some participants may require longer than 90 seconds of total collection time). 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) | Baseline (Before the procedure), during and Immediately following the dental procedure | Physiological markers of stress assessed via heart rate using a pulse oximeter device (pulse/minute) |
Countries
Canada