Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children

Study Overview
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Brief Summary
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This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of Hands/Eyes/mouth behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.

Detailed Description
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Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)Hands/Eyes/mouth and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank

Official Title
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Effectiveness of Hand/Eyes/Mouth Behavior Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: a Randomized Clinical Trial

Conditions
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Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders

Intervention / Treatment
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* Procedure: inferior alveolar and lingual nerve block procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars Exclusion Criteria: Preschool children with history of allergies to lidocaine (local anesthetic) Preschool children with systemic or neurological diseases Preschool children who have received local dental anesthesia before this study Preschool children who do not understand Spanish or Valencian language

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 71 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hand-eye-mouth technique<br>hand-eye-mouth (MOB) seeks to focus the patient in performing a sequence of movements in a fun way so that your attention is diverted from the puncture dental needle, also it seeks to the patient does not see the needle. The operator prior to infiltrate local anesthetic teaches the child a game to put the sleepy little water.After explain a first time, the sequence once or twice is repeated until the patient has mastered. We call this test. When we apply the anesthetic, the entire sequence must be repeated as in trials with the same tranquility and in the same tone of the game. The operator will use this technique during the inferior alveolar and lingual nerve block procedure | Procedure: inferior alveolar and lingual nerve block procedure<br>* The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines: Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). Syringe: carpule syringe-conventional harpoon with suction system.<br>* Other names: inferior alveolar and lingual nerve block;|
| Active Comparator: Conventional technique<br>the operator will explain how he/she will do the inferior alveolar and lingual nerve block procedure in phrases appropriates to the child. Then quietly cover the child´s field of view by hand during the inferior alveolar and lingual nerve block | Procedure: inferior alveolar and lingual nerve block procedure<br>* The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines: Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). Syringe: carpule syringe-conventional harpoon with suction system.<br>* Other names: inferior alveolar and lingual nerve block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preschool children´s anxiety levels-Facial Image Scale (FIS) | The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy-FIS) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preschool children´s pain levels-Wong Baker Faces Pain Scale | The children will be asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine) | At the end of local anesthesia procedure (2 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Infant Behavior, Heart rate, Dental Anxiety