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

Damascus University

Status: Completed

Conditions: Inferior Alveolar Nerve Block

Treatments: Procedure: Tablet Device; Procedure: VR Box; Drug: Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03428282

UDDS-Pedo-03-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

VR Box

Experimental group

Description:

Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention.

Treatment:

Procedure: VR Box

Tablet device

Experimental group

Description:

Inferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention.

Treatment:

Procedure: Tablet Device

Anesthesia

Active Comparator group

Description:

Inferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied.

Treatment:

Drug: Anesthesia