Freire 2008.
Methods | Randomized controlled trial with three groups (routine care; skin‐to‐skin; routine care + oral glucose) | |
Participants | 95 preterm infants (PMA 28 to 36 weeks) Painful procedure: heel lance Study period: unclear |
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Interventions | Intervention: 10 minutes of skin‐to‐skin care before, during heel stick Control: standard care during painful procedure Comparison: sweet taste 2 minutes before painful procedure Provider: mother |
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Outcomes | PIPP score | |
Notes | Country: Brazil Power calculation: yes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The groups were selected at random by a nurse on duty using closed envelopes" Not clear how the sequence was generated |
Allocation concealment (selection bias) | Unclear risk | "The groups were selected at random by a nurse on duty using closed envelopes" Not clear whether the envelopes were opaque, sealed and sequentially numbered |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The examiner was blinded and trained to record any grimacing..." "Only the newborn's face was filmed in close‐up with little surrounding area and minimal colour to reduce the possibility of unblinding by the research assistants who recorded the tapes". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were 10 neonates excluded due to errors in the blinding of the video (30/Fig 1). Data were provided only for all other neonates |
Selective reporting (reporting bias) | Low risk | All outcomes were clearly presented in Table 3 |
Other bias | Low risk | Study was apparently free of other sources of bias |