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 |
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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. |
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Outcomes | Pain measures:
Adverse events: none mentioned |
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Notes | Study dates: study dates not reported Funding: CSL Behring Conflicts of interest: none declared |
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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