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KSR Number: KSRA102796

Effectiveness of vibratory stimulation on needle-related procedural pain in children: a systematic review

Risk of Bias Assessment

Overall summary: High risk of bias in the review

Bottom Line

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.

Risk of Bias Assessment

Overall summary High risk of bias in the review

High

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

Details of Review

Number of studies 21
Number of participants 1,727
Last search date 10th October 2017
Review type Intervention
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.

Results

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).

Full Risk of Bias Assessment

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

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