NCT06724341

Impact of AR Glasses on Children's Behavior During Dental Nerve Blocks

Effect of Active and Passive Augmented Reality Glasses in Behavioral Children Management for Inferior Alveolar Nerve Block - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness of augmented reality glasses in managing pain, anxiety, and behavior in pediatric patients during inferior alveolar nerve block Group A (Control group): inferior alveolar nerve block will be administrated with passive behavior management (displaying animated movies directly on the screen of a mobile device). Group B: inferior alveolar nerve block will be administrated with displaying animated movies directly on the screen of a mobile device usage of the augmented reality glasses. Group C: Application of active behavior management by usage video games on the screen of a mobile device connected to augmented reality glasses before administration of inferior alveolar nerve block. Group D: An active and passive behavior management will be applied by usage video games before administration of inferior alveolar nerve block and animated movies during administration on the screen of a mobile device connected to augmented reality glasses. Children in all four groups will be assessed by using a combination of measures: Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt)

Detailed description

This study will evaluate the effectiveness of an augmented reality glasses. Pain, anxiety and general behavior will be evaluated during inferior alveolar nerve block using these behavioral scales, Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt) VPT scale consists of 8 associated drawings of a child, with each drawing showing a pair of children in two positions: non-anxious (value 0) and anxious (value 1). The child is asked to point to the child that expresses their feelings. The scale ranges from 0 to 8. If a child scores 6 or higher, they will be excluded from the research sample due to negative behavior. Anxiety is measured by monitoring pulse and oxygenation at five different times: before starting, 10 minutes later, when applying topical anesthetic, during the administration of the anesthetic injection, and immediately upon completion of the anesthetic injection. Using the Wong-Baker Faces scale to assess the level of pain after the anesthesia injection by asking the child to indicate the face that best represents their condition. The FLACC scale is a behavioral tool used to assess pain during the administration of an anesthesia injection. The child is recorded on video from before the injection starts until it is finished. The mobile phone is set up to film the child during the injection, and an external observer evaluates the child's behavior. The observer monitors five variables: (Face), (Legs), (Activity), (Cry), and (Consolability). Each variable is scored from 0 to 2, resulting in a total score ranging from 0 to 10. The Houpt scale was used to measure general behavior in children, as it consists of 6 points, starting from grade 1, which is the most violent behavior shown by the child during treatment, to grade 6, which is complete satisfaction with treatment.

Conditions

• Anaesthesia
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Distraction	Control group: inferior alveolar nerve block will be administrated with passive behavior management (displaying animated movies directly on the screen of a mobile device). Movies group: inferior alveolar nerve block will be administrated with displaying animated movies directly on the screen of a mobile device usage of the augmented reality glasses. Video games group: Application of active behavior management by usage video games on the screen of a mobile device connected to augmented reality glasses before administration of inferior alveolar nerve block. Movies and Video games group: An active and passive behavior management will be applied by usage video games before administration of inferior alveolar nerve block and animated movies during administration on the screen of a mobile device connected to augmented reality glasses.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-03-01
• Completion: 2025-05-01
• First posted: 2024-12-09
• Last updated: 2025-11-17

Locations

1 site across 1 country: Syria