Clinical trial NCT02578160: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Pain
Infant Behavior
Heart Rate and Rhythm Disorders
Keywords: pain
infant behaviour
heart rate
dental anxiety
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 52
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Preschool children's anxiety levels changes before and after anesthesia procedure - Facial Image Scale (FIS)
timeFrame: Baseline and after one week
Secondary outcomes:
measure: Preschool children's pain levels - Wong-Baker FACES Pain Scale
timeFrame: At the end of the local anesthesia procedure (2 minutes)
measure: Preschool children's behavior - Frankl Behavioral Rating Scale
timeFrame: Baseline and during the local anesthesia procedure (2 minutes)
measure: Heart rates
timeFrame: Baseline and during local anesthesia procedure
measure: Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire
timeFrame: Baseline
measure: family socioeconomic indicators - questionnaire related to socioeconomic conditions
timeFrame: Baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculdade de Odontologia da Universidade de Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Marcelo Bönecker
role: STUDY_DIRECTOR
References: