- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07636330
Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment
June 4, 2026 updated by: Randa Soussou, University of British Columbia
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?
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Randa Soussou
- Phone Number: 604-822-6819
- Email: randa.soussou@dentistry.ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- UBC Graduate Pediatric Dental Clinic
-
Contact:
- Randa Soussou
- Phone Number: 604-822- 6819
- Email: randa.soussou@dentistry.ubc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Distraction
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.
|
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.
|
|
Active Comparator: Standard Behaviour Guidance
Children receive standard behaviour guidance techniques commonly used in pediatric dentistry, such as tell-show-do and positive reinforcement, without VR distraction.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline Pre-procedural and Immediately following the dental procedure (same day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (pcg/L) baseline at the dental consultation appointment at time for the consent for the study and immediately following the dental procedure
Time Frame: baseline at the dental consultation appointment at time for the consent for the study 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).
|
baseline at the dental consultation appointment at time for the consent for the study and immediately following the dental procedure
|
|
Physiological Stress Response (Heart Rate)
Time Frame: 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)
|
Baseline (Before the procedure), during and Immediately following the dental procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 2, 2026
Primary Completion (Estimated)
June 18, 2027
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
May 22, 2026
First Submitted That Met QC Criteria
June 4, 2026
First Posted (Actual)
June 9, 2026
Study Record Updates
Last Update Posted (Actual)
June 9, 2026
Last Update Submitted That Met QC Criteria
June 4, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25-03739 (Other Identifier: UBC Clinical Research Ethics Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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