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. 2018 Oct 4;2018(10):CD005179. doi: 10.1002/14651858.CD005179.pub4

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
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.
Outcomes Pain measure:
  • Child self‐report: VAS

  • Child self‐report: FPS‐R


Adverse events: none mentioned
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
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.