Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment

N/ANot Yet RecruitingNCT07636330

University of British Columbia80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Dental Anxiety in Children Pain

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

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 procedure