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

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Anaesthesia

• Registration Number: NCT06724341
• Lead Sponsor: Damascus University

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)

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety levels	before starting, ten minutes after stating, after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection	Pulse Oximeter
Pain Levels	after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection]	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)

Secondary Outcome Measures

Name	Time	Method
General Behavior Level	during administration of inferior alveolar nerve block.	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