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

Damascus University102 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Interventions

VR BoxPROCEDURE

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

Tablet DevicePROCEDURE

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

AnesthesiaDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Peadodontics, University of Damascus Dental School

Damascus, Syria

Outcomes

Primary Outcomes

Pain levels

using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.

Time frame: five minutes following the inferior alveolar nerve block injection.

Anxiety levels

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)

Time frame: Within the first minute of injecting the needle into the oral mucosa (oral tissues).

Change in physiological pulse rate

using Finger Pulse Oximeter

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.