Immersive Virtual Reality for Pain and Dental Anxiety During Pediatric Restorative Treatment

This single‐center, two‐arm, parallel‐group randomized controlled clinical trialevaluated the effects of immersive virtual reality (VR) distraction during restorativedental treatment in children aged 8‐12 years.Children requiring restorative treatment of mandibular second primary molars withocclusal carious lesions classified as ICDAS II codes 2‐4 were eligible forparticipation. Eligible children were randomly assigned in a 1:1 ratio to either animmersive VR group or a control group. Randomization was performed using acomputer‐generated sequence, with allocation concealed in sequentially numbered, opaque,sealed envelopes.Children in the VR group used an immersive VR headset during the dental procedure andwatched the same age‐appropriate animated video throughout treatment. The headset wasplaced approximately one minute before administration of local anesthesia and remained inplace until completion of the restorative procedure. Children in the control groupreceived routine restorative dental treatment without a distraction intervention.All dental procedures were performed by the same calibrated pediatric dentist accordingto a standardized clinical protocol. Local anesthesia was administered using an inferioralveolar nerve block with 1.8 mL of 2% lidocaine through a 30‐gauge dental needle. Therestorative procedure was performed on mandibular second primary molars and lastedapproximately 10‐15 minutes.The primary outcome was children's pain perception, assessed using the Wong‐Baker FacesPain Rating Scale. Secondary outcomes included behavioral cooperation, dental anxiety,dental fear, emotional responses, physiological parameters, parent and cliniciansatisfaction, and treatment duration.Pain was assessed during and immediately after treatment. Behavioral cooperation andphysiological parameters were assessed before, during, and after treatment. Dentalanxiety and emotional responses were assessed before and after treatment, while dentalfear was evaluated using a validated questionnaire. Parent and clinician satisfactionwere assessed immediately after treatment.The study was conducted in accordance with the ethical principles of the Declaration ofHelsinki. The study protocol received approval from the Sanko University ClinicalResearch Ethics Committee (KAEK‐028‐1). Written informed consent was obtained from theparents or legal guardians, and verbal assent was obtained from the participatingchildren.