search
Back to results

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

Primary Purpose

Dental Anxiety, Pain, Infant Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
inferior alveolar and lingual nerve block procedure
Sponsored by
Evelyn Alvarez Vidigal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring pain, infant behaviour, heart rate, dental anxiety

Eligibility Criteria

36 Months - 71 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculdade de Odontologia da Universidade de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tell-Show-Do Behavior Technique

"Conventional Technique"

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
Heart rates
Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire
family socioeconomic indicators - questionnaire related to socioeconomic conditions
questionnaire related to family socioeconomic conditions

Full Information

First Posted
October 12, 2015
Last Updated
October 22, 2016
Sponsor
Evelyn Alvarez Vidigal
search

1. Study Identification

Unique Protocol Identification Number
NCT02578160
Brief Title
Efficacy of Tell-Show-Do Behavior-Management Technique During Local Anesthesia in Preschool Children
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Evelyn Alvarez Vidigal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders
Keywords
pain, infant behaviour, heart rate, dental anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tell-Show-Do Behavior Technique
Arm Type
Experimental
Arm Description
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).
Arm Title
"Conventional Technique"
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
inferior alveolar and lingual nerve block procedure
Intervention Description
inferior alveolar and lingual nerve block
Primary Outcome Measure Information:
Title
Preschool children's anxiety levels changes before and after anesthesia procedure - Facial Image Scale (FIS)
Description
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)
Time Frame
Baseline and after one week
Secondary Outcome Measure Information:
Title
Preschool children's pain levels - Wong-Baker FACES Pain Scale
Description
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)
Time Frame
At the end of the local anesthesia procedure (2 minutes)
Title
Preschool children's behavior - Frankl Behavioral Rating Scale
Description
It will be evaluated children's behavior (definitely negative, negative, definitely positive, positive) during de local anesthesia procedure
Time Frame
Baseline and during the local anesthesia procedure (2 minutes)
Title
Heart rates
Time Frame
Baseline and during local anesthesia procedure
Title
Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire
Time Frame
Baseline
Title
family socioeconomic indicators - questionnaire related to socioeconomic conditions
Description
questionnaire related to family socioeconomic conditions
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Bönecker
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Odontologia da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
July 2016

Learn more about this trial

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

We'll reach out to this number within 24 hrs