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

NCT06724341 | Completed DMC

• 1 other identifier: UDDS-Pedo-05-2024
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Anaesthesia; Anxiety

Keywords

Complementary Therapies; Pediatric Dentistry; Behavior Management; Augmented Reality Glasses

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• General Behavior Level

  during administration of inferior alveolar nerve block.

Study Arms (4)

Control group: inferior alveolar nerve block will be administrated with passive behavior management

EXPERIMENTAL

Behavioral: Distraction

Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di

EXPERIMENTAL

Behavioral: Distraction

Video games group: Application of active behavior management by usage video games on the screen of a

EXPERIMENTAL

Behavioral: Distraction

Movies and Video games group: An active and passive behavior management will be applied by usage vid

EXPERIMENTAL

Behavioral: Distraction

Interventions

Distraction BEHAVIORAL

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.

Control group: inferior alveolar nerve block will be administrated with passive behavior management; Movies and Video games group: An active and passive behavior management will be applied by usage vid; Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di; Video games group: Application of active behavior management by usage video games on the screen of a

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Pediatric Dentistry

Damascus, Syrian Arab Republic, DM20AM19, Syria

Location

Related Publications (3)

• 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.

  PMID: 31899840 BACKGROUND

• 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.

  PMID: 33565986 BACKGROUND

• 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.

  PMID: 40965811 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Mai Maher Albaal, DDS

  Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Damascus, Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)