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Completed

NCT Number: NCT03428282

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

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

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Key information

Conditions

Inferior Alveolar Nerve Block

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Peadodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous dental experience
  • systematic or mental disorders.
  • definitely negative or negative ratings of Frankel scale
  • Any contraindication for regional anesthesia

Treatment and study plan

VR Box

Procedure

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

Other names: Virtual Reality Eyeglasses

Tablet Device

Procedure

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

Anesthesia

Drug

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

Primary outcomes

  1. Pain levels

    Time frame: five 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'.

  2. Anxiety levels

    Time frame: Within 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)

  3. Change in physiological pulse rate

    Time frame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug

    using Finger Pulse Oximeter

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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