Johnston 2003.
Methods | Randomized cross over trial | |
Participants | 74 infants (32 to 36 weeks PMA) Postnatal age, range, days: 0 to 10 Birth weight, mean ± SD (range), grams: 2054 ± 406 (1320‐3125) Painful procedure: heel lance Study period: 9 April 2001 to 28 June 2002 |
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Interventions | Intervention: 30 minutes of skin‐to‐skin care before and during heel stick Control: standard care during painful procedure Provider: mother |
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Outcomes | PIPP score at 30, 60, 90, and 120 minutes Secondary outcomes: heart rate and oxygen saturation |
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Notes | Country: Canada Power calculation: yes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Ordering of conditions was determined randomly by a computer‐generated program." |
Allocation concealment (selection bias) | Low risk | Off site computer generated program (information obtained from authors) |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The camera was in close‐up focus on the neonate's face, with little surrounding area, no sound, and minimal colour, and turned 60 degrees in the KC condition so as to decrease the possibility of unblinding by research assistants who scored the tapes. Research assistants, who were blinded to the purpose of the study by being told that the study was about neonatal facial actions, coded facial actions in the laboratory of the principal investigator." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were provided for all 74 neonates included in the study |
Selective reporting (reporting bias) | Low risk | Data were provided for all outcome measures listed in the methods section. |
Other bias | Low risk | "There was a minimum of 24 hours and a maximum of 7 days between conditions, because the frequency of blood sampling was determined by clinical considerations." Study is apparently free of other sources of bias |