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

Not Applicable

Completed

• Conditions: Inferior Alveolar Nerve Block
• Interventions: Procedure: VR Box; Procedure: Tablet Device; Drug: Anesthesia

• Registration Number: NCT03428282
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-09
• Primary Completion: 2018-02-10
• Status Verified: 2018-07
• Study Completion: 2018-07-15
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR Box	VR Box	Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention.
Tablet device	Tablet Device	Inferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention.
Anesthesia	Anesthesia	Inferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied.

Primary Outcome Measures

Name	Time	Method
Pain levels	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'.
Anxiety levels	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)
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 drug	using Finger Pulse Oximeter

Trial Locations

Locations (1)

Department of Peadodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic