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

Primary Purpose

Dental Anxiety, Pain, Infant Behavior

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
inferior alveolar and lingual nerve block procedure
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring pain, Infant Behavior, Heart rate, Dental Anxiety

Eligibility Criteria

36 Months - 71 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Facultad de Odontología. Universidad Cardenal Herrera CEU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"hand-eye-mouth" technique

Conventional technique

Arm 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

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

Outcomes

Primary Outcome Measures

Preschool children´s anxiety levels-Facial Image Scale (FIS)
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

Preschool children´s pain levels-Wong Baker Faces Pain Scale
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)

Full Information

First Posted
October 28, 2015
Last Updated
July 17, 2017
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT02591797
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Pain, Infant Behavior, Heart Rate and Rhythm Disorders
Keywords
pain, Infant Behavior, Heart rate, Dental Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"hand-eye-mouth" technique
Arm Type
Experimental
Arm 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
Arm Title
Conventional technique
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
inferior alveolar and lingual nerve block procedure
Other Intervention Name(s)
inferior alveolar and lingual nerve block
Intervention Description
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: Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). Syringe: carpule syringe-conventional harpoon with suction system.
Primary Outcome Measure Information:
Title
Preschool children´s anxiety levels-Facial Image Scale (FIS)
Description
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)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Preschool children´s pain levels-Wong Baker Faces Pain Scale
Description
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)
Time Frame
At the end of local anesthesia procedure (2 minutes)
Other Pre-specified Outcome Measures:
Title
Preschool children´s behavior-Frank behavioral rating Scale
Description
It will be evaluated children´s behavior (definitely negative, negative,definitely positive, positive)during the local anethesia procedure
Time Frame
baseline and during the local anesthesia procedure (2 minutes)
Title
Heart rates
Time Frame
baseline and during the local anesthesia procedure (2 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Ribelles Llop, PhD
Organizational Affiliation
Director of Pediatric Dentistry Master. Cardenal Herrera CEU University
Official's Role
Study Director
Facility Information:
Facility Name
Facultad de Odontología. Universidad Cardenal Herrera CEU
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
36260279
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.
Results Reference
derived

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

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