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

NCT02578160 | Unknown

• 1 other identifier: EBEMATECH
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Pain; Infant Behavior; Heart Rate and Rhythm Disorders

Keywords

pain; infant behaviour; heart rate; dental anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Preschool children's pain levels - Wong-Baker FACES Pain Scale

  At the end of the local anesthesia procedure (2 minutes)

• Preschool children's behavior - Frankl Behavioral Rating Scale

  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

  Baseline

Study Arms (2)

Tell-Show-Do Behavior Technique

EXPERIMENTAL

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

"Conventional Technique"

ACTIVE COMPARATOR

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

Interventions

inferior alveolar and lingual nerve block procedure PROCEDURE

inferior alveolar and lingual nerve block

"Conventional Technique"; Tell-Show-Do Behavior Technique

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Preschool children with severe dental caries who need dental pulp treatment and / or tooth extraction of inferior primary molars.

You may not qualify if:

• 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

Sponsors & Collaborators

• Evelyn Alvarez Vidigal: lead

Study Sites (1)

Faculdade de Odontologia da Universidade de Sao Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Pain; Infant Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Behavior; Behavior

Study Officials

• Marcelo Bönecker

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)