Analgesic and Sedative Effects of Virtual Reality on Children with Acute Pulpitis: A Study Protocol for a Randomised Controlled Trial

Background: Root canal treatment is common in dentistry. Pulp exposure and drainage during the procedure cause significant discomfort in children, triggering fear and anxiety that reduce their physical comfort and treatment compliance. Virtual reality (VR) glasses divert patients' attention from pain, alleviate anxiety, and feature simple operation and high safety. This study aims to investigate the safety and efficacy of virtual reality technology during pulp chamber open for drainage, providing empirical evidence for alleviating pain and reducing anxiety in pediatric patients undergoing the procedure. Methods: This study is designed as a single-center, randomized, controlled trial. This study will recruit 100 patients aged 6 to 12 years undergoing pulp chamber open for drainage. Participants will be randomly assigned to either the intervention or control group in a 1:1 ratio. Data collectors will be blinded to the study. The experimental group will receive conventional local anesthesia combined with VR glasses, while the control group will receive conventional local anesthesia alone. Assessments will be conducted at baseline collection (in the dental chair) (T0), during local anesthesia (T1), at pulp exposure (T2), and immediately after treatment completion (T3). Primary outcomes are pain scores (Wong-Baker FACES Pain Scale) and anxiety scores (Visual Analog Scale for Anxiety). Secondary outcomes include treatment compliance (Frankl Behavior Rating Scale), physiological parameters, adverse effects, and physician-patient satisfaction and acceptance. Trial Registration Number: ChiCTR2500111920.