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Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools

Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03428282
Enrollment
102
Registered
2018-02-09
Start date
2017-05-15
Completion date
2018-07-15
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inferior Alveolar Nerve Block

Brief summary

The aim of this study is to evaluate the effectiveness of two different audiovisual distraction techniques (Audio Video eyeglasses VR BOX/ Tablet) in the management of anxious pediatric patients during inferior alveolar nerve block Group A (Control group): IAN will be administrated with basic behavior guidance techniques and without using any type of distraction aids. Group B: IAN will be administrated with using AV eyeglasses VR BOX and wireless headphone. Group C: IAN will be administrated with using tablet device and wireless headphone All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale external evaluator

Detailed description

This study will evaluate the effectiveness of two types of distraction aids that contain video using (tablet device or VR BOX eyeglasses) and audio distraction using wireless headphone. pain and anxiety will be evaluated during inferior alveolar nerve block using three behavioral scales, Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale external evaluator. The first measure of heart pulse rate will be recorded directly when the patient seated comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken and the child patients will ask to choose a face that describe their status from one of the Wong Baker faces scale. For each child patient, all of the body responses will be recorded during the whole procedure and then will be evaluated by an external assessor to determine the children behavioral score according to FLACC scale.

Interventions

PROCEDUREVR Box

Distraction will be made during the injection of the drug using this method.

PROCEDURETablet Device

Distraction will be made during the injection of the drug using this method

DRUGAnesthesia

Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

1. age between 6 and 10 years. 2. no previous dental experience. 3. definitely positive or positive ratings of Frank scale. 4. Need of IAN block for any dental treatment.

Exclusion criteria

1. previous dental experience 2. systematic or mental disorders. 3. definitely negative or negative ratings of Frankel scale 4. Any contraindication for regional anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Pain levelsfive minutes following the inferior alveolar nerve block injection.using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.
Anxiety levelsWithin the first minute of injecting the needle into the oral mucosa (oral tissues).This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded once the needle penetrate the oral tissue. (0 low anxiety and pain level - 10 high anxiety and pain level)
Change in physiological pulse rate(1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drugusing Finger Pulse Oximeter

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026