Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children
July 17, 2017 updated by: Ana María Leyda Menéndez, Cardenal Herrera University
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia, Spain, 46010
- Facultad de Odontología. Universidad Cardenal Herrera CEU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: "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
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The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines:
Other Names:
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Active Comparator: 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
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The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preschool children´s anxiety levels-Facial Image Scale (FIS)
Time Frame: Baseline
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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)
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preschool children´s pain levels-Wong Baker Faces Pain Scale
Time Frame: At the end of local anesthesia procedure (2 minutes)
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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)
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At the end of local anesthesia procedure (2 minutes)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preschool children´s behavior-Frank behavioral rating Scale
Time Frame: baseline and during the local anesthesia procedure (2 minutes)
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It will be evaluated children´s behavior (definitely negative, negative,definitely positive, positive)during the local anethesia procedure
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baseline and during the local anesthesia procedure (2 minutes)
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Heart rates
Time Frame: baseline and during the local anesthesia procedure (2 minutes)
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baseline and during the local anesthesia procedure (2 minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Marta Ribelles Llop, PhD, Director of Pediatric Dentistry Master. Cardenal Herrera CEU University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
October 28, 2015
First Submitted That Met QC Criteria
October 28, 2015
First Posted (Estimate)
October 30, 2015
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 17, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMLUCHBR
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