Press 2003.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 46 control, 48 treatment Sex of children: 57 M, 37 F Age range of children: 6 ‐ 16 years Mean age of children: 11.5 ± 2.5 years (intervention); 9.9 ± 2.3 years (control) Needle procedure: venepuncture Diagnosis: none reported Inclusion criteria: 6 ‐ 16 years old, undergoing venepuncture, conscious, Hebrew –speaking, no hearing problems Exclusion criteria: none reported Setting: pediatric emergency department of the Saroka University Medical Centre, Israel |
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Interventions | 1. Active distraction: Children listened to music using headphones and were asked a question about the song’s content. 2. Standard care control: Nurses provided usual care. |
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Outcomes | Pain measures:
Adverse events: none mentioned |
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Notes | Study dates: study dates not reported 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) | Unclear risk | Randomized ‐ no further details. Insufficient information to permit judgment of 'low' or 'high' risk |
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 | High risk | Had a potential source of bias related to the specific study design (e.g. modified pain measure) |