Ueki Shingo, Yamagami Yuki, Makimoto Kiyoko
Faculty of Nursing, Mukogawa Women's University, Hyogo, Japan.
The Japan Centre for Evidence Based Practice: a Joanna Briggs Institute Centre of Excellence.
JBI Database System Rev Implement Rep. 2019 Jul;17(7):1428-1463. doi: 10.11124/JBISRIR-2017-003890.
The objective of this systematic review was to identify, evaluate and synthesize evidence of the effectiveness of vibratory stimulation to reduce needle-related procedural pain in children aged 18 years and younger.
Needle-related procedures (NRPs) are common medical procedures associated with pain. Children, in particular, experience unpredictable and severe pain in response to NRPs. The gate control theory is commonly used to countermeasure this pain. Based on this theory, various types of vibratory stimulation have been used to reduce pain in several clinical studies.
Participants were 0- to 18-year-old children who underwent NRPs for any condition. The intervention included any type of vibratory stimulation during the NRPs. The main outcome was pain measured on any pain scale, including both self-rated and observer-rated pain scales. The secondary outcomes were anxiety, the duration of the procedure and the success rate. All studies were randomized controlled trials (RCTs) or quasi-randomized trials published in English.
The search strategy aimed to identify both published and unpublished studies. A three-step search strategy was utilized in this review. An initial search of MEDLINE and CINAHL was undertaken, followed by a search for unpublished studies. Nine databases were used for the search in October 2017. Papers selected for retrieval were assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments. Any disagreements that arose between the reviewers were resolved through discussion. Quantitative data were extracted from papers included in the review using a standardized data extraction tool. Where possible, quantitative data were pooled in the statistical meta-analysis. All results were subject to double data entry. Effect sizes were expressed as risk ratios (for categorical data) and weighted mean differences (for continuous data), and their 95% confidence intervals were calculated for analysis.
Twenty-one RCTs involving 1727 children were identified. Blinding of the participants and those delivering the treatment was not achieved in all studies, introducing a potential risk of bias. Overall, the vibratory stimulation was significantly effective in reducing NRP pain in children as shown by measurement of self-rated pain outcomes (standardized mean difference [SMD]: -0.55, 95% confidence interval [CI]: -0.92 to -0.18) and observer-rated pain outcomes (SMD: -0.47, 95% CI: -0.76 to -0.18). Among secondary outcomes, the effect on the child's anxiety (SMD: -1.03, 95% CI: -1.85 to -0.20) was significant.
Vibratory stimulation was effective in reducing NRP pain in children; however, blinding was not possible in the trials. Moreover, heterogeneity was high. Therefore, the confidence in the evidence is low. Personal preference should be a priority when using vibratory stimulation in the clinical setting.
本系统评价的目的是识别、评估和综合有关振动刺激对18岁及以下儿童减少与针头相关的程序性疼痛有效性的证据。
与针头相关的程序（NRP）是常见的伴有疼痛的医疗程序。尤其是儿童，对NRP会经历无法预测的剧烈疼痛。闸门控制理论常用于应对这种疼痛。基于该理论，在多项临床研究中已使用各种类型的振动刺激来减轻疼痛。
参与者为0至18岁因任何情况接受NRP的儿童。干预措施包括在NRP期间进行任何类型的振动刺激。主要结局是使用任何疼痛量表测量的疼痛，包括自评和观察者评定的疼痛量表。次要结局是焦虑、程序持续时间和成功率。所有研究均为以英文发表的随机对照试验（RCT）或半随机试验。
检索策略旨在识别已发表和未发表的研究。本评价采用了三步检索策略。首先对MEDLINE和CINAHL进行检索，随后检索未发表的研究。2017年10月使用了9个数据库进行检索。入选的论文在纳入评价之前，由两名独立的评审员使用标准化的关键评价工具评估其方法学有效性。评审员之间出现的任何分歧通过讨论解决。使用标准化的数据提取工具从纳入评价的论文中提取定量数据。在可能的情况下，将定量数据汇总进行统计荟萃分析。所有结果都进行了双份数据录入。效应量以风险比（用于分类数据）和加权平均差（用于连续数据）表示，并计算其95%置信区间用于分析。
确定了21项涉及1727名儿童的RCT。并非所有研究都实现了参与者和实施治疗者的盲法，存在潜在的偏倚风险。总体而言，如通过自评疼痛结局测量（标准化均差[SMD]：-0.55，95%置信区间[CI]：-0.92至-0.18）和观察者评定疼痛结局（SMD：-0.47，95%CI：-0.76至-0.18）所示，振动刺激在减轻儿童NRP疼痛方面显著有效。在次要结局中，对儿童焦虑的影响（SMD：-1.03，95%CI：-1.85至-0.20）显著。
振动刺激在减轻儿童NRP疼痛方面有效；然而，试验中无法实现盲法。此外，异质性较高。因此，对证据的信心较低。在临床环境中使用振动刺激时，个人偏好应作为优先考虑因素。
