Summary of findings 5. Breathing compared to control for needle‐related procedural pain and distress in children and adolescents.

Breathing compared to control for needle‐related procedural pain and distress in children and adolescents
Patient or population: children aged 6‐15 years who are generally healthy, undergoing surgery, or have leukemia undergoing venipuncture or lumbar puncture Setting: hospital (outpatient/inpatient) Intervention: breathing Comparison: control
Outcomes	Anticipated absolute effects* (95% CI)		№ of participants (studies)	Certainty of the evidence (GRADE)	Comments**
	Risk with control	Risk with breathing
Self‐reported pain	The mean level of self‐reported pain in the control group ranged from 4 to 7.6 (adjusted to a 0 to 10 scale)	The mean level of self‐reported pain with breathing was 1.04 standard deviations lower (1.86 to 0.22 lower)	298 (4 RCTs)	⊕⊝⊝⊝ VERY LOW a,b,c	This result equates to a large difference in favor of breathing
Self‐reported distress	See comment	See comment	See comment	‐	This outcome was not assessed in any study
Observer‐reported pain	See comment	See comment	120 (1 RCT)	‐	This outcome was assessed in one study only
Observer‐reported distress	See comment	See comment	120 (1 RCT)	‐	This outcome was assessed in one study only
Behavioral measures‐ pain	See comment	‐	See comment	‐	This outcome was not assessed in any study
Behavioral measures‐ distress	See comment	See comment	See comment	‐	This outcome was not assessed in any study
*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 twice for inconsistency due to considerable heterogeneity (I²) > 90%.
^c Downgraded once for imprecision: analysis based on < 400 participants per group.