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 |
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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. |
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Outcomes | Pain measure:
Adverse events: none mentioned |
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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 |
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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 |