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

Last updated: February 14, 2025
Sponsor: Damascus University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Distraction

Clinical Study ID

NCT06724341
UDDS-Pedo-05-2024
  • Ages 7-9
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children aged between 7 and 9 years

  2. Children categorized as having positive or definitely positive behavior on Franklbehavioral scale.

  3. Children whose dental treatment requires an IANB injection.

  4. Children with neither previous dental anesthesia experience nor augmented realityexperience.

  5. Children who do not suffer from any neurological, psychological or hearing disorders

Exclusion

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 Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: Distraction
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
April 01, 2025

Study 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.

Connect with a study center

  • Department of Pediatric Dentistry

    Damascus, DM20AM19
    Syrian Arab Republic

    Active - Recruiting

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