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

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)

Study Overview

• Status: Completed
• Conditions: Anaesthesia; Anxiety
• Intervention / Treatment: Behavioral: Distraction

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syria
  • Syrian Arab Republic
    • Damascus, Syrian Arab Republic, Syria, DM20AM19
      • Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged between 7 and 9 years
2. Children categorized as having positive or definitely positive behavior on Frankl behavioral scale.
3. Children whose dental treatment requires an IANB injection.
4. Children with neither previous dental anesthesia experience nor augmented reality experience.
5. Children who do not suffer from any neurological, psychological or hearing disorders

Exclusion Criteria:

1. Children who refuse to put the glasses on.
2. Children suffering from acute dental pain.
3. Children suffering from auditory or visual disturbances

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group: inferior alveolar nerve block will be administrated with passive behavior management	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.
Experimental: Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di	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.
Experimental: Video games group: Application of active behavior management by usage video games on the screen of a	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.
Experimental: Movies and Video games group: An active and passive behavior management will be applied by usage vid	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety levels	VPT scale	before starting, ten minutes after stating, and after inferior alveolar nerve block injection
Pain Levels	Wong-Baker FACES	After administration of inferior alveolar nerve block
Pain Levels	The Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded during the administration of inferior alveolar nerve block. (0 low pain level - 10 highpain level)	after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection]
Anxiety levels	Pulse Oximeter	before starting, ten minutes after stating, after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Behavior Level	Houpt scale 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	during administration of inferior alveolar nerve block.

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Mai Maher Albaal, DDS, Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Damascus, Syria

Publications and helpful links

General Publications

• Yeung AWK, Tosevska A, Klager E, Eibensteiner F, Laxar D, Stoyanov J, Glisic M, Zeiner S, Kulnik ST, Crutzen R, Kimberger O, Kletecka-Pulker M, Atanasov AG, Willschke H. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021 Feb 10;23(2):e25499. doi: 10.2196/25499.
• Zafar S, Zachar JJ. Evaluation of HoloHuman augmented reality application as a novel educational tool in dentistry. Eur J Dent Educ. 2020 May;24(2):259-265. doi: 10.1111/eje.12492. Epub 2020 Jan 20.
• Albaal M, Bshara N. Evaluating the use of augmented reality in alleviating anxiety and pain in children during intraoral injection administration: a randomized-controlled trial. Eur Arch Paediatr Dent. 2025 Sep 18. doi: 10.1007/s40368-025-01113-7. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Complementary Therapies; Pediatric Dentistry; Behavior Management; Augmented Reality Glasses
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Surgical Procedures, Operative; Orthopedic Procedures; Bone Lengthening; Osteogenesis, Distraction
• Other Study ID Numbers: UDDS-Pedo-05-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No