Dental Anxiety in ChildrenNCT07636330
Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment
A study testing Immersive Virtual Reality Headset and Standard Behaviour Guidance in people with Dental Anxiety in Children and Pain, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety in Children, Pain
- What is being tested?
- Immersive Virtual Reality Headset and Standard Behaviour Guidance
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
UBC Graduate Pediatric Dental Clinic
Vancouver, British Columbia, V6T 1Z3
Randa Soussou, 604-822- 6819, randa.soussou@dentistry.ubc.ca
About this study
Official title: Effects of Immersive Virtual Reality on Pain, Anxiety, and Post-Procedural Experience in Pediatric Dental Treatment: A Randomized Controlled 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?
Read more
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
- Conditions
- Dental Anxiety in Children, Pain
- Being tested
- Immersive Virtual Reality Headset, Standard Behaviour Guidance
- Keywords
- Distraction, Virtual reality, Pediatric Dentistry, Dental Anxiety, Procedural Pain
- Medical subject headings
- Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality HeadsetDevice
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 GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Immersive Virtual Reality Headset |
| 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. Receives: Behavioral: Standard Behaviour Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Pre-procedural and Immediately following the dental procedure (same day)
Secondary outcomes (2)
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.
Measured: 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)
Measured: Baseline (Before the procedure), during and Immediately following the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start2 Jun 2026 (estimated)
- Primary completion18 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Soussou, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636330
- Sponsor's protocol ID
- H25-03739
- Other IDs
- H25-03739
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality on Pain, Anxiety, and Post-Procedural Experience in Pediatric Dental Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07636330
- Acronym / sponsor ID
- H25-03739
- Conditions
- Dental Anxiety in Children, Pain
- Keywords
- Distraction, Virtual reality, Pediatric Dentistry, Dental Anxiety, Procedural Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Distraction | Experimental | Device: Immersive Virtual Reality HeadsetChildren 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. |
| Standard Behaviour Guidance | Active comparator | Behavioral: Standard Behaviour GuidanceChildren receive standard behaviour guidance techniques commonly used in pediatric dentistry, such as tell-show-do and positive reinforcement, without VR distraction. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality HeadsetA 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. | Device | VR Distraction |
| Standard Behaviour GuidanceStandard 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. | Behavioural | Standard Behaviour Guidance |
Primary outcome
Self-Reported Pain During Dental Procedure Using Faces Pain Scale
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Headset and Standard Behaviour Guidance in people with Dental Anxiety in Children and Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randa Soussou (604-822-6819, randa.soussou@dentistry.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Pain During Dental Procedure Using Faces Pain Scale (time frame: Baseline Pre-procedural and Immediately following the dental procedure (same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.