Miguez‐Navarro 2016.
Study characteristics | ||
Methods | RCT. 2 arms. | |
Participants | Number of children: 70 control, 70 treatment Sex of children: 81 M, 59 F Age range of children: 3 ‐ 11 years Mean age range of children: 6.82 years Needle procedure: venipuncture Diagnosis of child: none reported Inclusion criteria: 3 ‐ 11 years, required venipuncture Exclusion criteria: psychomotor retardation, chronic pathologies, any consciousness disorder, classified as Priority 1 or 2 (in a system of 5 levels of triage), parents or guardians did not sign the informed consent Setting: emergency department in Madrid, Spain |
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Interventions | 1.Video distraction: From the beginning of the procedure, children were shown short videos of cartoons frequently watched by Spanish children using a portable DVD player. The videos were chosen by each child. Parents were not allowed in the procedure room. 2. Control: Standard venipuncture procedures were followed. |
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Outcomes | Pain measures:
Distress measure:
Physiological measure:
Adverse events: none mentioned |
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Notes | Study dates: July to December 2011. 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: "generated by Research Randomizer" (p. 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) | High risk | One or more outcomes of interest are reported incompletely (i.e. heart rate) |
Other bias | High risk | Multiple potential sources of bias related to study design (e.g. parents not allowed in intervention group only) |