Clinical trial NCT02591797: Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children
Official title: Effectiveness of Hand/Eyes/Mouth 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: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Pain
Infant Behavior
Heart Rate and Rhythm Disorders
Keywords: pain
Infant Behavior
Heart rate
Dental Anxiety
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2015-10-30
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 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

Eligibility criteria: 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

Primary outcomes:
measure: Preschool children´s anxiety levels-Facial Image Scale (FIS)
timeFrame: Baseline
Secondary outcomes:
measure: Preschool children´s pain levels-Wong Baker Faces Pain Scale
timeFrame: At the end of local anesthesia procedure (2 minutes)
Other outcomes:
measure: Preschool children´s behavior-Frank behavioral rating Scale
timeFrame: baseline and during the local anesthesia procedure (2 minutes)
measure: Heart rates
timeFrame: baseline and during the local anesthesia procedure (2 minutes)
Locations:
city: Valencia
country: Spain
facility: Facultad de Odontología. Universidad Cardenal Herrera CEU
Study officials:
affiliation: Director of Pediatric Dentistry Master. Cardenal Herrera CEU University
name: Marta Ribelles Llop, PhD
role: STUDY_DIRECTOR
References:
citation: Leyda-Menendez AM, Vidigal EA, Abanto J, Ribelles-Llop M. Efficacy of two behavioural management techniques during inferior alveolar nerve block administration in pre-school children: a randomised clinical trial. Eur Arch Paediatr Dent. 2023 Feb;24(1):85-93. doi: 10.1007/s40368-022-00758-y. Epub 2022 Oct 19.