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. 2018 Oct 4;2018(10):CD005179. doi: 10.1002/14651858.CD005179.pub4

Summary of findings 3. Hypnosis compared to control for needle‐related procedural pain and distress in children and adolescents.

Hypnosis compared to control for needle‐related procedural pain and distress in children and adolescents
Patient or population: children aged 3‐16 years with chronic illness (cancer) or generally healthy undergoing bone marrow aspirations, lumbar punctures, venipuncture, or local dental anesthetic
Setting: hospital (inpatient/outpatient), community clinic
Intervention: hypnosis
Comparison: control
Outcomes Anticipated absolute effects* (95% CI) № of participants
(studies) Certainty of the evidence
(GRADE) Comments**
Risk with control Risk with hypnosis
Self‐reported pain The mean level of self‐reported pain in the control group ranged from 4.17 to 8.6 (adjusted to a 0 to 10 scale) The mean level of self‐reported pain with hypnosis was 1.40 standard deviations lower
(2.32 to 0.48 lower) 176
(5 RCTs) ⊕⊝⊝⊝
VERY LOW a,b,c,d This result equates to a large difference in favor of hypnosis
Self‐reported distress See comment The mean level of self‐reported distress with hypnosis was 2.53 standard deviations lower
(3.93 to 1.12 lower) 176
(5 RCTs) ⊕⊝⊝⊝
VERY LOW a,c,d,e This result equates to a large difference in favor of hypnosis
Observer‐reported pain See comment See comment See comment .‐ This outcome was not assessed in any study
Observer‐reported distress See comment See comment. 36
(1 RCT) This outcome was assessed in one study only
Behavioral measures‐ pain See comment The mean level of behavioral pain with hypnosis was 0.38 standard deviations lower
(1.57 lower to 0.81 higher) 69
(2 RCTs) ⊕⊝⊝⊝
VERY LOW a,b,c There is no evidence of an effect of hypnosis
Behavioral measures‐ distress See comment The mean level of behavioral distress with hypnosis was 1.15 standard deviations lower
(1.76 to 0.53 lower) 193
(6 RCTs) ⊕⊝⊝⊝
VERY LOW a,b,c,d This result equates to a large difference in favor of hypnosis
*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 evidenceHigh 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 twice for imprecision: analysis based on < 100 participants per group.
d Downgraded once for possibility of publication bias given that almost all trials are from one expert group.
e Downgraded twice for inconsistency due to considerable heterogeneity (I2) > 90%.