Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: inferior alveolar nerve block will be administrated with passive behavior management | Experimental |
| |
| Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di | Experimental |
| |
| Video games group: Application of active behavior management by usage video games on the screen of a | Experimental |
| |
| Movies and Video games group: An active and passive behavior management will be applied by usage vid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mai Maher Albaal, DDS | Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Damascus, Syria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Dentistry | Damascus | Syrian Arab Republic | DM20AM19 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31899840 | Background | 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. | |
| 33565986 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D019857 | Osteogenesis, Distraction |
| ID | Term |
|---|---|
| D001852 | Bone Lengthening |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 40965811 | Derived | 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. 2026 Jun;27(3):739-749. doi: 10.1007/s40368-025-01113-7. Epub 2025 Sep 18. |