Efficacy of Tell-Show-Do 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 study will be to evaluate the effectiveness of Tell-Show-Do 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, University of Sao Paulo, Brazil. 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 anesthetic 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) Tell-Show-Do 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 Frankl.

Official Title
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Efficacy of Tell-Show-Do 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: 1. 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 anaesthesia before this study

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: Tell-Show-Do Behavior Technique<br>This technique will involve verbal explanations related to the inferior alveolar and lingual nerve block procedure in phrases appropriate to the developmental level of the patient (tell);demonstrations for the patient of the visual, auditory, olfactory, and tactile aspects of the procedure in a carefully defined, nonthreatening setting (show); and then, without deviating from the explanation and demonstration, completion of the procedure (do). | Procedure: inferior alveolar and lingual nerve block procedure<br>* inferior alveolar and lingual nerve block<br>|
| 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>* inferior alveolar and lingual nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preschool children's anxiety levels changes before and after anesthesia procedure - 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 and after one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preschool children's pain levels - Wong-Baker FACES Pain Scale | The children were 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 the local anesthesia procedure (2 minutes) | 
| Preschool children's behavior - Frankl Behavioral Rating Scale | It will be evaluated children's behavior (definitely negative, negative, definitely positive, positive) during de local anesthesia procedure | Baseline and during the local anesthesia procedure (2 minutes) | 
| Heart rates |  | Baseline and during local anesthesia procedure | 
| Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire |  | Baseline | 
| family socioeconomic indicators - questionnaire related to socioeconomic conditions | questionnaire related to family socioeconomic conditions | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, infant behaviour, heart rate, dental anxiety