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Efficacy of Tell-Show-Do Behavior-Management Technique During Local Anesthesia in Preschool Children

NCT ID: NCT02578160

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

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.

Conditions

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Dental Anxiety Pain Infant Behavior Heart Rate and Rhythm Disorders

Keywords

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pain infant behaviour heart rate dental anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tell-Show-Do Behavior Technique

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).

Group Type EXPERIMENTAL

inferior alveolar and lingual nerve block procedure

Intervention Type PROCEDURE

inferior alveolar and lingual nerve block

"Conventional Technique"

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.

Group Type ACTIVE_COMPARATOR

inferior alveolar and lingual nerve block procedure

Intervention Type PROCEDURE

inferior alveolar and lingual nerve block

Interventions

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inferior alveolar and lingual nerve block procedure

inferior alveolar and lingual nerve block

Intervention Type PROCEDURE

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

1. Preschool children with history of allergies to Lidocaine (local anesthetic)
2. Preschool children with systemic or neurological diseases
3. Preschool children who have received local dental anaesthesia before this study
Minimum Eligible Age

36 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evelyn Alvarez Vidigal

OTHER

Sponsor Role lead

Responsible Party

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Evelyn Alvarez Vidigal

PhD Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcelo Bönecker

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Faculdade de Odontologia da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EBEMATECH

Identifier Type: -

Identifier Source: org_study_id