Current evidence suggests that vibratory stimulation may reduce pain and anxiety in children undergoing needle-related procedures. For venipuncture procedures, vibratory stimulation may not impact the duration of the procedure or its success rate. Of note, these conclusions should be interpreted with caution, since methodological restrictions based on study quality and language mean that relevant studies may have been missed, and publication bias and heterogeneity were high for some outcomes.Future trials with an adequate placebo-controlled comparator arm and assessor blinding are needed to provide higher quality evidence to address this review question.
Overall summary High risk of bias in the review
Studies were restricted based on quality and language (only English and Japanese studies were included), meaning relevant studies may have been missed. Heterogeneity remained high for some outcomes even after subgroup analysis. Publication bias was present for some outcomes.
|A. Did the interpretation of findings address all of the concerns identified in Domains 1 to 4?||Probably no|
|B. Was the relevance of identified studies to the review's research question appropriately considered?||Probably yes|
|C. Did the reviewers avoid emphasizing results on the basis of their statistical significance?||Probably yes|
|Risk of bias in the review||High|
|Number of studies||21|
|Number of participants||1,727|
|Last search date||10th October 2017|
|Objective||To evaluate the effectiveness of vibratory stimulation for reducing needle-related procedural pain in children aged 18 years or younger.|
|Population||Children aged 18 years and younger who underwent needle-related procedurals (NRPs) for any condition.
NRPs included puncture (finger, vein, artery, lumbar or bone marrow examination), injection (vascular, muscular, subcutaneous or intradermal) or intravenous catheter insertion.
|Interventions||Any type of vibratory stimulation (including devices with an additional function to reduce pain, such as cooling stimulation).|
|Comparator||No vibratory stimulation.|
|Outcome||Primary outcome: pain measured on any pain scale, including both self-rated and observer-rated pain scales.
Secondary outcomes: anxiety and heart rate; and the duration of the procedure and the success rate for venipuncture needle-related procedures.
|Study design||Randomised controlled trials (RCTs) or quasi-randomised trials.
If no RCTs were identified, the reviewers pre-specified that any experimental study design would then be included, such as non-RCTs and quasi-experimental pre-and-post studies.
In terms of pain, pooled analysis reported a reduction in needle-related procedural pain in children receiving vibratory stimulation compared to no stimulation based on both self-rated pain (standardised mean difference [SMD] -0.55, 95% confidence interval [CI] -0.92 to -0.18; 13 trials, n=1,589 participants) and observer-rated pain (SMD -0.47, 95% CI -0.76 to -0.18; 16 trials, n=1,721 participants).
In terms of anxiety, pooled analysis reported a reduction in anxiety associated with needle-related procedural pain in children receiving vibratory stimulation compared to no stimulation (SMD -1.03, 95% CI -1.85 to -0.20; 4 trials, n=624 participants).
In terms of the duration of the procedure for venipuncture needle-related procedural pain, pooled analysis reported no difference in the duration of the procedure for vibratory stimulation compared to no stimulation (SMD -0.20, 95% CI -0.64 to 0.24; 2 trials)
In terms of success rate for venipuncture needle-related procedural pain, pooled analysis reported no difference in the success rate of first venipuncture for vibratory stimulation compared to no stimulation (odds ratio [OR] 1.23, 95% CI 0.62 to 2.45; 4 studies, n=523 participants).
The research objective was clearly stated. Eligibility criteria were well described and appeared appropriate to address the review question. Studies were restricted based on study quality (only studies meeting two quality assessment criteria pertaining to randomisation and baseline comparability were included). Studies were restricted based on language (only English and Japanese studies were included).
|1.1 Did the review adhere to pre-defined objectives and eligibility criteria?||Probably yes|
|1.2 Were the eligibility criteria appropriate for the review question?||Probably yes|
|1.3 Were eligibility criteria unambiguous?||Probably yes|
|1.4 Were all restrictions in eligibility criteria based on study characteristics appropriate (e.g. date, sample size, study quality, outcomes measured)?||Probably no|
|1.5 Were any restrictions in eligibility criteria based on sources of information appropriate (e.g. publication status or format, language, availability of data)?||Probably no|
|Concerns regarding specification of study eligibility criteria||High|
MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials and Igaku Chuo Zasshi were searched for relevant studies. In addition, ClinicalTrials.gov, EU Clinical Trials Register, UMIN Clinical Trials Registry, OpenGrey and the reference lists of retrieved articles were searched for further relevant studies. The search strategy was reported in full and appeared adequate. The initial search was conducted by two reviewers independently. Two reviewers were independently involved in the study selection and disagreements were resolved by discussion or by consulting a third reviewer.
|2.1 Did the search include an appropriate range of databases/electronic sources for published and unpublished reports?||Probably yes|
|2.2 Were methods additional to database searching used to identify relevant reports?||Probably yes|
|2.3 Were the terms and structure of the search strategy likely to retrieve as many eligible studies as possible?||Probably yes|
|2.4 Were restrictions based on date, publication format, or language appropriate?||Probably yes|
|2.5 Were efforts made to minimise error in selection of studies?||Probably yes|
|Concerns regarding methods used to identify and/or select studies||Low|
Two review authors were independently involved in the data extraction process. Sufficient study characteristics appear to have been extracted to allow interpretation of results. Relevant study results appear to have been extracted. Methodological quality of the included studies was assessed using the Joanna Briggs Institute's standardised critical appraisal instruments for randomised controlled trials. Two reviewers were independently involved in the assessment of study quality and any disagreements were resolved by discussion or by consultation with a third reviewer.
|3.1 Were efforts made to minimise error in data collection?||Probably yes|
|3.2 Were sufficient study characteristics considered for both review authors and readers to be able to interpret the results?||Probably yes|
|3.3 Were all relevant study results collected for use in the synthesis?||Probably yes|
|3.4 Was risk of bias (or methodological quality) formally assessed using appropriate criteria?||Probably yes|
|3.5 Were efforts made to minimise error in risk of bias assessment?||Probably yes|
|Concerns regarding methods used to collect data and appraise studies||Low|
The synthesis appeared to include all relevant studies. The method of analysis was explained and appeared appropriate. Heterogeneity was assessed and found to be significant for some outcomes. Subgroup analysis was performed to address the heterogeneity; however, heterogeneity remained high. Sensitivity analysis was also performed. Publication bias was assessed using visual inspection of funnel plots and Egger's test. Funnel plots were asymmetrical for self-rated and observer-rated pain outcomes; but Egger's test only indicated significant asymmetry for the self-rated pain outcome, suggesting the presence of publication bias. The quality of individual studies was considered in the synthesis.
|4.1 Did the synthesis include all studies that it should?||Probably yes|
|4.2 Were all pre-defined analyses reported or departures explained?||Probably yes|
|4.3 Was the synthesis appropriate given the degree of similarity in the research questions, study designs and outcomes across included studies?||Probably yes|
|4.4 Was between-study variation minimal or addressed in the synthesis?||Probably yes|
|4.5 Were the findings robust, e.g. as demonstrated through funnel plot or sensitivity analyses?||Probably no|
|4.6 Were biases in primary studies minimal or addressed in the synthesis?||Probably yes|
|Concerns regarding synthesis and findings||High|
OBJECTIVE: 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. INTRODUCTION: 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. INCLUSION CRITERIA: 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. METHODS: 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 the standardized data extraction tool from RevMan5 (Copenhagen: The Nordic Cochrane Center, Cochrane). Where possible, quantitative data were pooled in the statistical meta-analysis using RevMan5. 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. RESULTS: 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 (standard mean difference [SMD]: -0.55, 95% confidence interval [95% 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. CONCLUSIONS: Vibratory stimulation was effective at reducing NRP pain in children; however, blinding was not possible in the trials. Moreover, heterogeneity was high. Therefore, the confidence of the evidence is low. Personal preference should also be a priority when using vibratory stimulation in the clinical setting.