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| ID | Type | Description | Link |
|---|---|---|---|
| H25-03739 | Other Identifier | UBC Clinical Research Ethics Board |
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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:
Researchers will compare children using a VR headset during dental treatment to children receiving standard behaviour guidance techniques.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Distraction | Experimental | Children wear an immersive VR headset during routine dental treatment as a non-pharmacological distraction intervention. The VR headset provides an engaging visual and auditory environment to reduce pain and anxiety during the procedure. |
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| Standard Behaviour Guidance | Active Comparator | Children receive standard behaviour guidance techniques commonly used in pediatric dentistry, such as tell-show-do and positive reinforcement, without VR distraction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive Virtual Reality Headset | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline Pre-procedural and Immediately following the dental procedure (same day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randa Soussou | Contact | 604-822-6819 | randa.soussou@dentistry.ubc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBC Graduate Pediatric Dental Clinic | Vancouver | British Columbia | V6T 1Z3 | Canada |
A decision regarding individual participant data sharing has not yet been made. This study involves children (a vulnerable population) and data sharing plans will be determined in accordance with UBC Research Ethics Board requirements
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard Behaviour Guidance | Behavioral | 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. |
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| 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) | Physiological markers of stress assessed via heart rate using a pulse oximeter device (pulse/minute) | Baseline (Before the procedure), during and Immediately following the dental procedure |