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一项单中心研究者设盲的随机平行组研究方案,旨在通过心理、行为和实时生理参数,研究预适应预约对儿童在氧化亚氮/氧气镇静期间行为的影响。

A single-centre investigator-blinded randomised parallel-group study protocol to investigate the influence of an acclimatisation appointment on children's behaviour during NO/O sedation as measured by psychological, behavioural and real-time physiological parameters.

作者信息

Kowash Mawlood, Al-Halabi Manal, Hussein Iyad, Abdo Mohammad M, Salami Anas, Hassan Amar, Sverrisdottir Yrsa, Tahmassebi Jinous F

机构信息

Hamdan Bin Mohammed College of Dental Medicine, Mohammed Bin Rashid University of Medicine & Health Sciences, Dubai, United Arab Emirates.

College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, United Arab Emirates.

出版信息

BDJ Open. 2020 Mar 17;6:5. doi: 10.1038/s41405-020-0031-y. eCollection 2020.

DOI:10.1038/s41405-020-0031-y
PMID:32194987
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7078273/
Abstract

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 (NO) session prior to actual dental treatment with NO.

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 NO (aged 5-15 years) will be randomly assigned to; a study group: children who will have a preparatory NO trial experience or; a control group: children who will only have NO explained to them. Treatment with NO 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 NO acclimatising appointments. This RCT will supplement existing literature.

CONCLUSIONS

This RCT will report whether prior acclimatising of a child to NO sedation is effective, or not, in improving dental treatment behaviour.

摘要

目的与目标

描述一项随机对照试验(RCT)的研究方案,该试验旨在评估在实际使用一氧化二氮(NO)进行牙科治疗前,进行一次适应性一氧化二氮镇静(NO)疗程对减轻牙科焦虑的有效性。

材料与方法

在阿拉伯联合酋长国(UAE)迪拜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。需要使用NO的焦虑儿童(5至15岁)将被随机分配至;研究组:将有一次预备性NO试验体验的儿童,或;对照组:仅向其解释NO的儿童。两组的NO治疗均在第二次就诊时开始。将记录以下结果:牙科治疗的完成情况、基线及治疗后的焦虑评分(使用改良儿童牙科焦虑量表面部版)、儿童的行为(使用弗兰克尔行为评定量表)以及获取实时生理焦虑相关参数(使用E4电子腕部设备)。

结果

将对数据进行统计分析。

讨论

关于牙科NO适应性预约的研究较少。这项RCT将补充现有文献。

结论

这项RCT将报告儿童预先适应NO镇静是否能有效改善牙科治疗行为。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/c3deba6526bb/41405_2020_31_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/501abdac9386/41405_2020_31_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/1733c29c701a/41405_2020_31_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/b8c53b282bbf/41405_2020_31_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/c3deba6526bb/41405_2020_31_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/501abdac9386/41405_2020_31_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/1733c29c701a/41405_2020_31_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/b8c53b282bbf/41405_2020_31_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ce3/7078273/c3deba6526bb/41405_2020_31_Fig4_HTML.jpg

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