Summary of findings 1. Distraction compared to control for needle‐related procedural pain and distress in children and adolescents.
| Distraction compared to control for needle‐related procedural pain and distress in children and adolescents | |||||
| Patient or population: children aged 2‐19 years with mixed medical (acute or chronic illness) or generally healthy undergoing venipuncture, immunization, intravenous insertion, lumbar puncture, bone marrow aspiration, routine injection, allergy testing injections, or laceration repair Setting: hospital (inpatient/outpatient/emergency department), community clinic, or school Intervention: distraction Comparison: control (varied across studies) | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments** | |
| Risk with control | Risk with distraction | ||||
| Self‐reported pain | The mean level of self‐reported pain in the control group ranged from 0.65 to 8.32 (adjusted to a 0 to 10 scale). | The mean level of self‐reported pain with distraction was 0.56 standard deviations lower (0.78 to 0.33 lower). | 2802 (30 RCTs) | ⊕⊕⊝⊝ LOW a,b | This result equates to a moderate difference in favor of distraction |
| Self‐reported distress | See comment | The mean level of self‐reported distress with distraction was 0.82 standard deviations lower (1.45 to 0.18 lower) | 426 (4 RCTs) | ⊕⊝⊝⊝ VERY LOW a,b,c | This result equates to a large difference in favor of distraction |
| Observer‐reported pain | See comment | The mean level of observer‐reported pain with distraction was 0.62 standard deviations lower (1 to 0.23 lower) | 1512 (11 RCTs) | ⊕⊝⊝⊝ VERY LOW a,d | This result equates to a moderate to large difference in favor of distraction |
| Observer‐reported distress | See comment | The mean level of observer‐reported distress with distraction was 0.72 standard deviations lower (1.41 to 0.03 lower) | 1067 (5 RCTs) | ⊕⊝⊝⊝ VERY LOW a,d | This result equates to a moderate to large difference in favor of distraction |
| Behavioral measures‐ pain | See comment | The mean level of behavioral pain with distraction was 0.33 standard deviations lower (0.69 lower to 0.03 higher) | 309 (4 RCTs) | ⊕⊕⊝⊝ LOW a,c | There is no evidence of an effect of distraction |
| Behavioral measures‐ distress | See comment | The mean level of behavioral distress with distraction was 0.44 standard deviations lower (0.84 to 0.04 lower) | 500 (7 RCTs) | ⊕⊝⊝⊝ VERY LOW a,b,c | This result equates to a small to moderate difference in favor of distraction |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). **One 'rule of thumb' for interpreting the relative effect is that 0.2 represents a small difference, 0.5 a moderate difference and 0.8 a large difference. CI: confidence interval; SMD: standardized mean difference; RCT: randomized controlled trial | |||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | |||||
a Downgraded once for serious study limitations: most trials had unclear/high risk of bias in blinding, allocation concealment and/or selective reporting of outcomes. b Downgraded once for inconsistency due to moderate heterogeneity (I2) > 45%. c Downgraded once for imprecision: analysis based on < 400 participants per group.
d Downgraded twice for inconsistency due to considerable heterogeneity (I2) > 90%.