Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- change from baseline in Clinical Anxiety and Cooperation scales.
研究概览
简要总结
Visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. Dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. One strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. An alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 36 Months 至 78 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between3 to 6.5 year of old
- •Presence of moderate to severe dental anxiety
- •Parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment
- •Presence of at least one mandibular primary molar needed pulp treatment
- •positive dental history
排除标准
- •current episodes of medications or drug therapy
- •systemic or congenital disorders
- •mental retardation
研究组 & 干预措施
Nitrous Oxide-Oxygen
Children in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas.
干预措施: Nitrous Oxide-Oxygen conscious sedation (Drug)
cognitive-behavioral therapy
Children in this group were asked to come to playroom before entering operation room. Modeling , Benson relaxation and positive self-talking were instructed to them.
干预措施: cognitive-behavioral therapy (Behavioral)
结局指标
主要结局
change from baseline in Clinical Anxiety and Cooperation scales.
时间窗: baseline and 1 week
The anxiety and cooperation differences between the two dental visits (second visits were done after 1 week) were compared within the three groups.
次要结局
未报告次要终点
研究者
Fatemeh Mazhari
principle investigator
Mashhad University of Medical Sciences