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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Dental Anxiety; Infant Behavior; Heart Rate and Rhythm Disorders
• Intervention / Treatment: Procedure: inferior alveolar and lingual nerve block procedure

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-000
    • Faculdade de Odontologia da Universidade de são Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: inferior alveolar and lingual nerve block procedure; inferior alveolar and lingual nerve block
Active Comparator: "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.	Procedure: inferior alveolar and lingual nerve block procedure; inferior alveolar and lingual nerve block

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Evelyn Alvarez Vidigal
• Investigators: Study Director: Marcelo Bönecker, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 22, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pain; dental anxiety; heart rate; infant behaviour
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: EBEMATECH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: July 2016