NCT07636330

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

May 22, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2027

Expected
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 22, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

DistractionVirtual realityPediatric DentistryDental AnxietyProcedural Pain

Outcome Measures

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.

    Baseline Pre-procedural and Immediately following the dental procedure (same day)

Secondary Outcomes (2)

  • 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

    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)

    Baseline (Before the procedure), during and Immediately following the dental procedure

Study Arms (2)

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.

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.

Behavioral: Standard Behaviour Guidance

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.

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.

Standard Behaviour Guidance

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Graduate Pediatric Dental Clinic

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

PainPain, Procedural

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of British Columbia

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 9, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

June 18, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations