Oliveira 2017.
Study characteristics | ||
Methods | RCT (randomized cross‐over trial). 2 arms. | |
Participants | Number of children: 18 control, 22 treatment Sex of children: 16 M, 24 F Age range of children: 6 ‐ 12 years Mean age of children: 8.72 ± 1.80 years Needle procedure: venepuncture or arterial puncture Diagnosis: onco‐hematology (42.5%), endocrinology (15%), pulmonology (15%), nephrology (10%), rheumatology (7.5%), gastroenterology (2.5%), cardiology (2.5%), and immunology (2.5%) Inclusion criteria: children aged 6 – 12 years, sufficient language skills to communicate, in a hospital setting with different diagnoses, prescribed venipuncture or arterial puncture based on clinical demand, hospitalized for at least 1 day and had a time interval of not more than 7 days between the puncture procedures Exclusion criteria: children with neurological impairments or communication problems and children under sedation Setting: pediatric inpatient units in hospital in Brazil |
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Interventions | 1. Audiovisual distraction: Children watched short films on a portable DVD player before and throughout the procedure. A researcher directed the child's attention to the video by making comments about the scenes and characters. The parents of the children were present during the intervention, but they were instructed not to interfere with the procedure. 2. Usual care: Procedure conducted as in routine hospital care. At the time of the study, no non‐pharmacological or pharmacological protocols were adopted by the hospital in routine puncture procedures. |
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Outcomes | Pain measure:
Adverse events: none mentioned |
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Notes | We included only outcomes from Time 1, prior to the cross‐over. Study dates: March to November 2013 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: "randomizer.org" (p. 179) |
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 | Participants 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 | Low risk | Appears to be free of other bias that would affect outcomes. |