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

Bellieni 2006.

Study characteristics
Methods RCT. 3 arms.
Participants Number of children: 23 control, 46 treatment
Sex of children: 33 M, 36 F
Age range of children: 7 ‐ 12 years
Mean age of children: not reported (Median = 9 years for intervention; 8 years for control)
Needle procedure: venepuncture
Diagnosis of child: “outpatients”
Inclusion criteria: 7 ‐ 12 years old, last meal 3 hours before venepuncture
Exclusion criteria: neurodevelopmental delay, frequent venepunctures (> 1/year)
Setting: Italy, no other details provided
Interventions 1. Cartoon TV distraction: Cartoon played on a TV, started 120 seconds before venepuncture
2. Mother‐directed distraction: Active distraction by mothers during the venepuncture by speaking, caressing, and soothing
3. No distraction control: Mothers present and asked not to distract children
Outcomes Pain measures:
  • Child self‐report: Oucher Pain Rating Scale

  • Parent report of child pain: Oucher Pain Rating Scale


Adverse events: none mentioned
Notes Study dates: study dates not reported
Funding source: none stated
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using a random numbers from a computer generated sequence" p.1015 Par 2
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgment of 'low' or 'high' risk
Blinding of participants and personnel (performance bias)
All outcomes High risk Study participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk No blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing data
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgment of 'low' or 'high' risk
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists (e.g. parenting pain rating…"ignoring the score given by the child" p.1015)