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

Zieger 2013.

Study characteristics
Methods RCT. 2 arms.
Participants Number of children: 60 control, 60 treatment
Sex of children: 60 M, 60 F
Age range of children: 6 ‐ 12 years
Mean age range of children: 8.4 ± 2.4 years (treatment), 8.7 ± 2.1 years (control)
Needle procedure: venipuncture
Diagnosis of child: mixed
Inclusion criteria: 6 ‐ 12 years, indication for a blood withdrawal, presence during the study of at least 1 parent with sufficient knowledge of German language
Exclusion criteria: none given
Setting: general pediatric and coagulation outpatient clinics in Germany
Interventions 1. Picture book: Children received a picture book before the procedure that showed a realistic representation of the blood withdrawal procedure performed on an 8‐year‐old boy. The decision for the use of local anesthesia was left to the attending physician.
2. Standard procedure: Children did not receive an object intervention or a systematic distraction. Instead, children had a waiting period. The decision for use of local anesthesia was left to the attending physician.
Outcomes Pain measures:
  • Child self‐report: FPS‐R

  • FLACC


Adverse events: none mentioned
Notes Study dates: study dates not reported
Funding: CSL Behring
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Block 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) Low risk Objectives clearly stated and reported fully
Other bias High risk Potential source of bias related to inconsistent use and duration of topical anesthetic

APPT: adolescent pediatric pain tool; BMA: bone marrow aspiration; CAMPIS‐R: child‐adult medical procedure inventory scale‐revised; CAPS: children's anxiety and pain scale; CAS: color analogue scale; CFCS: child facial coding system; CFS: children's fear scale; CHEOPS: Children's Hospital East Ontario pain scale; CNS: central nervous system; DPTP: diphtheria, pertussis, tetanus and poliomyelitis; EMLA: eutectic mixture of local anesthetics; FLACC: face, legs, activity, crying, consolability; FPS: faces pain scale; GDS: Groningen distress scale; GFS: glasses fear scale; IV: intravenous; LP: lumbar puncture; MOPS: modified objective pain score; MRI: magnetic resonance imaging; MTPPPS: modified toddler‐preschool post‐operative pain scale; mYAPS: modified Yale pre‐operative anxiety scale; NRS: numerical rating scale; OSBD: observational scale of behavioral distress; PBCL: procedural behavioral checklist; PBRS: procedural behavioral rating scale; PPQR: perception of procedures questionnaire‐revised; STAI‐C: state trait anxiety inventory for children; VAS: visual analogue scale