Summary of findings 2. CBT‐combined compared to control for needle‐related procedural pain and distress in children and adolescents.
| CBT‐combined compared to control for needle‐related procedural pain and distress in children and adolescents | ||||||
| Patient or population: children aged 3‐18 years with mixed medical (acute or chronic illness) or generally healthy undergoing immunization, intravenous insertion, venipuncture, bone marrow aspiration, insulin injection, or dental local anesthetic Setting: hospital (inpatient/outpatient/emergency department), community clinic, or school Intervention: CBT‐combined Comparison: control | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments** | |
| Risk with control | Risk with CBT‐combined | |||||
| Self‐reported pain | The mean level of self‐reported pain in the control group ranged from 0.84 to 8.4 (adjusted to a 0 to 10 scale). | The mean level of self‐reported pain with combined CBT was 0.27 standard deviations lower (0.58 lower to 0.03 higher) | 1359 (14 RCTs) | ⊕⊕⊝⊝ LOW a,b | There is no evidence of an effect of combined CBT | |
| Self‐reported distress | See comment | The mean level of self‐reported distress with combined CBT was 0.26 standard deviations lower (0.56 lower to 0.04 higher) | 234 (6 RCTs) | ⊕⊕⊝⊝ LOW a,c | There is no evidence of an effect of combined CBT | |
| Observer‐reported pain | See comment | The mean level of observer‐reported pain with combined CBT was 0.52 standard deviations lower (0.73 to 0.30 lower) | 385 (4 RCTs) | ⊕⊕⊝⊝ LOW a,c | This result equates to a moderate difference in favor of combined CBT | |
| Observer‐reported distress | See comment | The mean level of observer‐reported distress with combined CBT was 0.08 standard deviations higher (0.34 lower to 0.50 higher) | 765 (6 RCTs) | ⊕⊕⊝⊝ LOW a,b | There is no evidence of an effect of combined CBT | |
| Behavioral measures‐ pain | See comment | The mean level of behavioral pain with combined CBT was 0.65 standard deviations lower (2.36 lower to 1.06 higher) | 95 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW a,b,d | There is no evidence of an effect of combined CBT | |
| Behavioral measures‐ distress | See comment | The mean level of behavioral distress with combined CBT was 0.40 standard deviations lower (0.67 to 0.14 lower) | 1105 (11 RCTs) | ⊕⊕⊝⊝ LOW a,b | This result equates to a small to moderate difference in favor of combined CBT | |
| *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. dDowngraded twice for imprecision: analysis based on < 100 participants per group.