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

Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02578160
• Other study ID #: EBEMATECH
• Status: Active, not recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: October 22, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Months to 71 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• inferior alveolar and lingual nerve block procedure
inferior alveolar and lingual nerve block

Locations

Country	Name	City	State
Brazil	Faculdade de Odontologia da Universidade de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Evelyn Alvarez Vidigal

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	Heart rates		Baseline and during local anesthesia procedure	No
Secondary	Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire		Baseline	No
Secondary	family socioeconomic indicators - questionnaire related to socioeconomic conditions	questionnaire related to family socioeconomic conditions	Baseline	No