Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children

Not Applicable

Completed

• Conditions: Pain; Heart Rate and Rhythm Disorders; Dental Anxiety; Infant Behavior

• Registration Number: NCT02591797
• Lead Sponsor: Cardenal Herrera University

Brief Summary

This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" 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, Cardenal Herrera CEU University (Valencia, Spain). 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 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)"Hands/Eyes/mouth" 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 Frank

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Primary Completion: 2017-06
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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 anesthesia before this study
• Preschool children who do not understand Spanish or Valencian language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Preschool children´s anxiety levels-Facial Image Scale (FIS)	Baseline	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

Name	Time	Method
Preschool children´s pain levels-Wong Baker Faces Pain Scale	At the end of local anesthesia procedure (2 minutes)	The children will be 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)

Trial Locations

Locations (1)

Facultad de Odontología. Universidad Cardenal Herrera CEU; 🇪🇸 Valencia, Spain