Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of British Columbia
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Immersive Virtual Reality Headset
DeviceA 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
BehavioralStandard 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: VR DistractionExperimental treatment 1 intervention
Group B: Standard Behaviour GuidanceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-Reported Pain During Dental Procedure Using Faces Pain Scale
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.
Time frame
Baseline Pre-procedural and Immediately following the dental procedure (same day)Secondary outcomes
1
Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (U/L) baseline before any dental treatment and immediately following the dental procedure
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.
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.2
Physiological Stress Response (Heart Rate)
Physiological markers of stress assessed via heart rate using a pulse oximeter device (pulse/minute)
Time frame
Baseline (Before the procedure), during and Immediately following the dental procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: