Clinical trial NCT06724341: Impact of AR Glasses on Children's Behavior During Dental Nerve Blocks
Official title: Effect of Active and Passive Augmented Reality Glasses in Behavioral Children Management for Inferior Alveolar Nerve Block - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anaesthesia
Anxiety
Keywords: Complementary Therapies
Pediatric Dentistry
Behavior Management
Augmented Reality Glasses
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 108
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety levels
timeFrame: before starting, ten minutes after stating, and after inferior alveolar nerve block injection
measure: Pain Levels
timeFrame: After administration of inferior alveolar nerve block
measure: Pain Levels
timeFrame: after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection]
measure: Anxiety levels
timeFrame: 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:
measure: General Behavior Level
timeFrame: during administration of inferior alveolar nerve block.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Pediatric Dentistry
Study officials:
affiliation: Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Damascus, Syria
name: Mai Maher Albaal, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.