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

This single-center, two-arm, parallel-group randomized controlled clinical trial evaluated the effects of immersive virtual reality (VR) distraction during restorative dental treatment in children aged 8-12 years.

Children requiring restorative treatment of mandibular second primary molars with occlusal carious lesions classified as ICDAS II codes 2-4 were eligible for participation. Eligible children were randomly assigned in a 1:1 ratio to either an immersive VR group or a control group. Randomization was performed using a computer-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 and watched the same age-appropriate animated video throughout treatment. The headset was placed approximately one minute before administration of local anesthesia and remained in place until completion of the restorative procedure. Children in the control group received routine restorative dental treatment without a distraction intervention.

All dental procedures were performed by the same calibrated pediatric dentist according to a standardized clinical protocol. Local anesthesia was administered using an inferior alveolar nerve block with 1.8 mL of 2% lidocaine through a 30-gauge dental needle. The restorative procedure was performed on mandibular second primary molars and lasted approximately 10-15 minutes.

The primary outcome was children's pain perception, assessed using the Wong-Baker Faces Pain Rating Scale. Secondary outcomes included behavioral cooperation, dental anxiety, dental fear, emotional responses, physiological parameters, parent and clinician satisfaction, and treatment duration.

Pain was assessed during and immediately after treatment. Behavioral cooperation and physiological parameters were assessed before, during, and after treatment. Dental anxiety and emotional responses were assessed before and after treatment, while dental fear was evaluated using a validated questionnaire. Parent and clinician satisfaction were assessed immediately after treatment.

The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The study protocol received approval from the Sanko University Clinical Research Ethics Committee (KAEK-028-1). Written informed consent was obtained from the parents or legal guardians, and verbal assent was obtained from the participating children.

Inclusion criteria

Children aged 8-12 years. Children requiring dental treatment under local anesthesia. Children who are able to understand and follow the study instructions. Children whose parents/legal guardians provide written informed consent. Children who provide age-appropriate assent to participate.

Exclusion criteria

Children with systemic, neurological, psychiatric, cognitive, or developmental conditions that may affect anxiety or pain assessment.

Children with visual or auditory impairments that prevent appropriate use of the VR system or communication with the investigator.

Children with a history of seizures or other conditions for which VR use is contraindicated.

Children who refuse to participate or whose parents/legal guardians withdraw consent.

Children who are unable to complete the dental treatment or study assessments.