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 |
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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 |
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Outcomes | Pain measures:
Adverse events: none mentioned |
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Notes | Study dates: study dates not reported Funding source: none stated Conflicts of interest: none declared |
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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) |