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

C

Cardenal Herrera University

Status

Completed

Conditions

Dental Anxiety
Infant Behavior
Pain
Heart Rate and Rhythm Disorders

Treatments

Procedure: inferior alveolar and lingual nerve block procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT02591797
AMLUCHBR

Details and patient eligibility

About

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.

Full 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

Enrollment

52 patients

Sex

All

Ages

36 to 71 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

"hand-eye-mouth" technique
Experimental group
Description:
"hand-eye-mouth" (MOB) seeks to focus the patient in performing a sequence of movements in a fun way so that your attention is diverted from the puncture dental needle, also it seeks to the patient does not see the needle. The operator prior to infiltrate local anesthetic teaches the child a "game" to put "the sleepy little water".After explain a first time, the sequence once or twice is repeated until the patient has mastered. We call this test. When we apply the anesthetic, the entire sequence must be repeated as in trials with the same tranquility and in the same tone of the game. The operator will use this technique during the inferior alveolar and lingual nerve block procedure
Treatment:
Procedure: inferior alveolar and lingual nerve block procedure
Conventional technique
Active Comparator group
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
Treatment:
Procedure: inferior alveolar and lingual nerve block procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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