Kostandy 2008.
Methods | Randomized cross‐over trial | |
Participants | Only 10 infants (30 to 32 weeks' PMA) enrolled Postnatal age, range, days: 2 to 9 Birth weight, mean ± SD, grams: 1577 ± 327.00 Painful procedure: heel lance Study period: unclear |
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Interventions | Intervention: 30 minutes of skin‐to‐skin care before and during painful procedure Control: standard care during painful procedure Provider: mother provided skin‐to‐skin care |
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Outcomes | Cry duration at baseline, warming, heel stick, and recovery | |
Notes | Country: United States Power calculation: yes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomisation was by permuted block design to ensure highest possible equivalence among infants." The system of randomization is not mentioned |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Independent scorers of the videotapes were blind to the purpose and cross‐over design of the study." Not clear if mothers' skin/breasts could be noted by researchers |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "All mothers who were approached agreed to participate." |
Selective reporting (reporting bias) | Low risk | Outcomes listed in methods match those reported |
Other bias | Low risk | "26 subjects were needed to detect moderate difference in crying time; however, funding permitted recruitment of only 10 subjects." 24 hour between procedures ‐ carry‐over effect: "Heel sticks were done by a consistent neonatal phlebotomist who used the National Association of Neonatal Nursing's standardized heel stick procedure with a Tenderfoot(TM) spring‐loaded lancet." |