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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Preschool children´s anxiety levels-Facial Image Scale (FIS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 36 Months to 71 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
"hand-eye-mouth" technique
"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
Intervention: inferior alveolar and lingual nerve block procedure (Procedure)
Conventional technique
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
Intervention: inferior alveolar and lingual nerve block procedure (Procedure)
Outcomes
Primary Outcomes
Preschool children´s anxiety levels-Facial Image Scale (FIS)
Time Frame: 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 Outcomes
- Preschool children´s pain levels-Wong Baker Faces Pain Scale(At the end of local anesthesia procedure (2 minutes))
Investigators
Ana María Leyda Menéndez
Dr. Associate Professor to the Pediatric Dentistry Master
Cardenal Herrera University