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

Harrison 1991.

Study characteristics
Methods RCT. 2 arms.
Participants Number of children: 50 control, 50 treatment
Sex of children: 51 M, 49 F
Age range of children: 6 ‐ 12 years
Mean age range of children: 8.4 years
Needle Procedure: venous blood sampling
Diagnosis of child: none given
Inclusion criteria: 6 ‐ 12 years
Exclusion criteria: none given
Setting: 4 hospital laboratories in Kuwait
Interventions 1. Preparation: Children were read a picture book just prior to the procedure that described the venous blood sampling procedure, why it is carried out, and what happens to the blood after it has been collected. The story stressed that pain is noticeable during the procedure but not unbearable, and that the procedure is less painful if you relax your arm and cooperate with the technician. Children were encouraged to ask questions.
2. No preparation control: No specific description was mentioned in the study. However, it was noted that initial observations revealed that laboratory technicians generally made no attempt to prepare children or to talk to them through the procedure. If children protested and struggled, their strategy was to physically restrain the child and complete the procedure. Often, parents were recruited to help.
Outcomes Pain measures:
  • Child self‐report: VAS (0 ‐ 5)

  • Parent observer‐report of child pain: VAS (0 ‐ 5)


Distress measures:
  • Parent observer report of child’s fear: VAS (0 ‐ 5)


Physiological measures:
  • Radial pulse rate post‐procedure


Adverse events: none mentioned
Notes Study dates: study dates not reported
Funding: Kuwait University Project MU072
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk 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 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 Unclear risk Insufficient reporting of exclusions to permit judgment of 'low' or 'high' risk (e.g. some parent report missing)
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgment of 'low' or 'high' risk
Other bias High risk Had a potential source of bias related to the specific study design (e.g. potential impact of group setting)