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

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
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.
Outcomes Pain measures:
  • Child self‐report (3 ‐ 7 year olds): Wong Baker FACES scale

  • Child self‐report (8 ‐ 11 year olds): Numerical rating scale (0 ‐ 10)


Distress measure:
  • Child self‐report: Groninger Distress Scale


Physiological measure:
  • Heart rate: beats per minute


Adverse events: none mentioned
Notes Study dates: July to December 2011.
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: "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)