Inal 2012.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 62 control, 61 treatment Sex of children: 62 M, 61 F Age range of children: 6 ‐ 12 years Mean age of children: 9.36 ± 1.96 years Needle procedure: venepuncture Diagnosis of child: heterogeneous Inclusion criteria: 6 ‐ 12 years old, required blood tests Exclusion criteria: neurodevelopmentally delayed, verbal difficulties, hearing or vision impairments, had taken an analgesic within last 6 hours, had a history of syncope due to blood draws. Setting: Pediatric Clinic of Cerrahpasa Medical Faculty, Istanbul University |
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Interventions | 1. Distraction: Children looked at “Flippits®” distraction cards while a nurse asked the child questions about the cards. 2. Standard care control: Children received no intervention. |
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Outcomes | Pain measure:
Distress measure:
Adverse events: none mentioned |
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Notes | Study dates: January 14 to February 20, 2010 Funding: 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: "randomized with a computer‐generated table of random numbers" (p. 212 Par 6) |
Allocation concealment (selection bias) | High risk | Use of an open random allocation schedule (e.g. random‐number table) |
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 |