Liu 2015.
Methods | Randomized Controlled Trial | |
Participants | 40 term infants (mean = 39.3 weeks GA) Birth weight, mean, ± SD, grams: Skin‐to‐skin: 3337 ± 409.1; Control: 3740 ± 298.9) Painful procedure: heel lance Study period: April 2010 to December 2010 |
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Interventions | Intervention: skin‐to‐skin 15 mins pre heel lance, during, 1 minute after Control: post bath, swaddled during and 1 minute after |
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Outcomes | Douleur Aiguë du Nouveau‐né (DAN), cry time (seconds), pain facial expression (seconds), oxygen saturation, heart rate | |
Notes | Power calculation: N/A Country: United States |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table method was used to generate the sequence. |
Allocation concealment (selection bias) | Unclear risk | No information was provided regarding who had access to the number table used to allocate the intervention. It would be feasible to predict the nurse recruiting participants had access to this table; however, information as to who had access is not provided. |
Blinding (performance bias and detection bias) All outcomes | High risk | Impossible to blind personnel and participants to group assignment, no attempt to blind outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The authors indicate that they selected 40 infants (intervention n = 20; intervention n = 20), however, they do not provide numbers for each of the individual outcomes (only for the final number of infants included in the sample, which was 40). Therefore, it is unclear if there was incomplete data for any particular outcome. |
Selective reporting (reporting bias) | High risk | The authors do not report if there was a statistically significant difference between the intervention and control group on the DAN ‐ they only report on the duration of facial expression and crying times. They do not report the DAN scores whatsoever in their results section. |
Other bias | High risk | The authors do not discuss training of personal to complete facial coding for the scoring of the DAN. |