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Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

Por: Browne · P. D. · den Hollander · B. · Speksnijder · E. M. · van Wering · H. M. · Tjon a Ten · W. · George · E. K. · Groeneweg · M. · Bevers · N. · Wessels · M. M. S. · van den Berg · M. M. · Goede · J. · Teklenburg-Roord · S. T. A. · Frankenhuis · C. · Benninga · M. A. · Vlieger · A
Introduction

The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.

Methods and analysis

To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.

Ethics and dissemination

Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.

Trial registration number

NTR5814.

Interruptions during intravenous medication administration: A multicentre observational study 静脉给药中断:多中心观测研究

Abstract

Aims

The aim of this study was to determine the frequency and cause of interruptions during intravenous medication administration, which factors are associated with interruptions and to what extent interruptions influence protocol compliance.

Background

Hospital nurses are frequently interrupted during medication administration, which contributes to the occurrence of administration errors. Errors with intravenous medication are especially worrisome, given their immediate therapeutic effects. However, knowledge about the extent and type of interruptions during intravenous medication administration is limited.

Design

Multicentre observational study.

Methods

Data were collected during two national evaluation studies (2011 ‐ 2012 & 2015 ‐ 2016). Nurses were directly observed during intravenous medication administration. An interruption was defined as a situation where a break during the administration was needed or where a nurse was distracted but could process without a break. Interruptions were categorized according to source and cause. Multilevel logistic regression analyses were conducted to assess the associations between explanatory variables and interruptions or complete protocol compliance.

Results

In total, 2,526 intravenous medication administration processes were observed. During 291 (12%) observations, nurses were interrupted 321 times. Most interruptions were externally initiated by other nurses (19%) or patients (19%). Less interruptions occurred during the evening (odds ratio: 0.23 [95% confidence interval: 0.08–0.62]). Do‐not‐disturb vests were worn by 61 (2%) nurses. No significant association was found between being interrupted and complete protocol compliance.

Conclusion

An interruption occurred in every eight observed intravenous medication administration, mainly caused by other nurses or patients. One needs to consider critically which strategies effectively improve safety during the high‐risk nursing‐task of intravenous medication administration.

目的

本研究旨在确定静脉给药中断的频率和原因、哪些因素与中断有关、及中断对协议遵从的影响程度。

背景

给药过程中,医院护士常被打断,这会导致用药错误。静脉注射药物错误尤为堪忧,因其直接影响治疗效果,但有关静脉给药中断的程度和类型的知识却有限。

设计

多中心观测研究

方法

在两项国家评估研究过程中收集数据(2011‐2012 和 2015‐2016)。给药过程中直接对护士进行观察。中断是指在给药过程中需要休息的情况,或护士分心,但不需要休息就可以处理的情况。中断根据来源和原因进行分类。进行多级逻辑回归分析以评估解释变量与中断或完全协议遵从之间的关系。

结果

共观测2526例静脉给药过程。在291次(12%)观测中,有321次护士被中断。中断主要由其他护士(19%)或患者造成。晚上发生中断较少(比值比:0.23【95%】置信区间:0.08–0.62)。61名(2%)护士穿着免打扰背心。未发现中断和完全协议遵从性之间有明显关联。

结论

每8次静脉给药中观测到1次中断,主要由其他护士或患者造成。在静脉给药的高风险护理任务中,需要慎重考虑哪些策略能有效提高安全。

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