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

Vessey 1994.

Study characteristics
Methods RCT. 2 arms.
Participants Number of children: 50 control, 50 treatment
Sex of children: 62 M, 38 F
Age range of children: 3.6 ‐ 12.11 years
Mean age of children: 7 years 4 months ± 3.3 months
Needle procedure: routine blood draw
Diagnosis: none
Inclusion criteria: must have had 2 or fewer blood draws in the 6 months preceding the procedure, free of chronic conditions, fluent in English
Exclusion criteria: none given
Setting: ambulatory care clinic of a children’s hospital in the South Centre USA
Interventions 1. Distraction: Children were distracted using the Illusion Kaleidoscope. They were encouraged to concentrate on what they were seeing.
2. Standard care control: Children received standard procedure preparation.
Outcomes Pain measure:
  • Child self‐report: Wong‐Baker FACES Pain Rating Scale

  • Behavioral: CHEOP scale


Adverse events: none mentioned
Notes The authors found that age was a significant covariate, whereby younger children reported perceiving greater intensities of pain and demonstrated more active observable behavioral distress to the venepuncture than the older children. They provided adjusted means (but not adjusted SDs). Since the adjusted means were only slightly different from the original means, we used the original means and SDs for the analyses in this review.
Study dates: study dates not reported
Funding: University of Arkansas for Medical Sciences, College of Nursing, Intramural Grants Program, and the U.S. Public Health Service, Division of Nursing, Advanced Nursing Education Award, Grant #D23‐NU‐00948‐02
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "subjects were randomly assigned…using a random number table" (p. 370 Par 10)
Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e.g. random‐number table)
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel were not blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk No blinding of self‐report 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 Unclear risk Insufficient information to assess whether an important risk of bias exists