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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Preschool children´s anxiety levels-Facial Image Scale (FIS)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 36 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars
排除标准
- •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
研究组 & 干预措施
"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
干预措施: 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
干预措施: inferior alveolar and lingual nerve block procedure (Procedure)
结局指标
主要结局
Preschool children´s anxiety levels-Facial Image Scale (FIS)
时间窗: 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)
次要结局
- Preschool children´s pain levels-Wong Baker Faces Pain Scale(At the end of local anesthesia procedure (2 minutes))
研究者
Ana María Leyda Menéndez
Dr. Associate Professor to the Pediatric Dentistry Master
Cardenal Herrera University