Aims and objectives

To describe a study protocol of a randomised control trial (RCT) assessing the effectiveness, in reducing dental anxiety, of an acclimatising nitrous oxide sedation (N₂O) session prior to actual dental treatment with N₂O.

Materials and methods

A single-centre investigator-blinded parallel-group RCT conducted in a postgraduate dental hospital in Dubai, United Arab Emirates (UAE). Anxious children requiring N₂O (aged 5–15 years) will be randomly assigned to; a study group: children who will have a preparatory N₂O trial experience or; a control group: children who will only have N₂O explained to them. Treatment with N₂O for both groups will start at the second visit. The following outcomes will be recorded: completion of dental treatment, anxiety scores at baseline and after treatment (using the Modified Child Dental Anxiety Scale faces), behaviour of the child (using Frankl Rating Behaviour Scale) and the acquisition of real-time physiological anxiety-related parameters (using E4^® electronic wrist devices).

Results

The data will be analysed statistically.

Discussion

There is a paucity of research regarding dental N₂O acclimatising appointments. This RCT will supplement existing literature.

Conclusions

This RCT will report whether prior acclimatising of a child to N₂O sedation is effective, or not, in improving dental treatment behaviour.

中文翻译：

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一项单中心调查员盲随机平行组研究方案，以调查通过心理、行为和实时生理参数测量的 N 2 O/O 2 镇静期间适应任命对儿童行为的影响

目的和目标

描述一项随机对照试验 (RCT) 的研究方案，评估在使用 N 2 O 进行实际牙科治疗之前适应环境的一氧化二氮镇静剂 (N 2 O) 在减少牙科焦虑_方面的_有效性。

材料和方法

在阿拉伯联合酋长国迪拜 (UAE) 的一家研究生牙科医院进行的单中心研究者盲法平行组 RCT。_{需要 N 2} O 的焦虑儿童（5-15 岁）将被随机分配到；一个研究组：将有预备 N ₂ O 试验经验的儿童，或；对照组：只向他们解释 N ₂ O 的儿童。N _2处理两组的 O 将在第二次访问时开始。将记录以下结果：完成牙科治疗、基线和治疗后的焦虑评分（使用改良的儿童牙科焦虑量表面部）、儿童的行为（使用弗兰克尔评分行为量表）和实时生理焦虑的获得- 相关参数（使用 E4 ^®电子腕设备）。

结果

数据将进行统计分析。

讨论

关于牙科 N ₂ O 适应预约的研究很少。该随机对照试验将补充现有文献。

结论

该 RCT 将报告儿童先前对 N ₂ O 镇静剂的适应是否对改善牙科治疗行为有效或无效。