Efficacy of Tell-Show-Do 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
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Preschool children's anxiety levels changes before and after anesthesia procedure - 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 study will be to evaluate the effectiveness of "Tell-Show-Do" 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, University of Sao Paulo, Brazil. 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 anesthetic 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) Tell-Show-Do 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 Frankl.
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 anaesthesia before this study
研究组 & 干预措施
Tell-Show-Do Behavior Technique
This technique will involve verbal explanations related to the inferior alveolar and lingual nerve block procedure in phrases appropriate to the developmental level of the patient (tell);demonstrations for the patient of the visual, auditory, olfactory, and tactile aspects of the procedure in a carefully defined, nonthreatening setting (show); and then, without deviating from the explanation and demonstration, completion of the procedure (do).
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 changes before and after anesthesia procedure - Facial Image Scale (FIS)
时间窗: Baseline and after one week
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 the local anesthesia procedure (2 minutes))
- Preschool children's behavior - Frankl Behavioral Rating Scale(Baseline and during the local anesthesia procedure (2 minutes))
- family socioeconomic indicators - questionnaire related to socioeconomic conditions(Baseline)
- Heart rates(Baseline and during local anesthesia procedure)
- Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire(Baseline)
研究者
Evelyn Alvarez Vidigal
PhD Student
University of Sao Paulo