Nimbalkar 2013.
Methods | Randomized cross‐over trial | |
Participants | 47 preterm infants (PMA 32 0/7 to 36 6/7 weeks) Postnatal age, mean, days: within 10 days Birth weight, mean, grams: 1730 (intervention), unclear (control) Painful procedure: heel lance Study period: 1 April 2009 to 30 September 2009 |
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Interventions | Intervention: 15 minutes of skin‐to‐skin care before, during, and 15 minutes after heel lance Control: standard care during painful procedure Provider: mother |
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Outcomes | PIPP score | |
Notes | Country: India Power calculation: yes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization of patients to give KMC or not for the first heel prick was done using graphpad.com (a web‐based program)..." |
Allocation concealment (selection bias) | Unclear risk | "the random numbers were stored in opaque envelopes, which were opened once the patient entered study." Envelopes should be opaque, sealed, and sequentially numbered. |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The persons examining the video were unaware of the status of the neonate during analysis as the videography was done by focusing only on the baby's face and the surroundings were not visible, with the sound kept on mute." "Mothers were asked to keep their hands clasped behind the neonate's back throughout the procedure and refrain from touching the neonate's head with her face and from vocalizing to the neonate during filming (to keep observers blind)." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rates were clearly explained in Figure 2 |
Selective reporting (reporting bias) | Low risk | Outcomes were clearly laid out in Figure 2 and Table 2 |
Other bias | Low risk | "There was a minimum of 24 h and a maximum of 7 d gap between the conditions. The heels were assessed for any signs of inflammation so as to remove it as a confounding factor." "Only two staff nurses did the heel prick for these neonates to keep the procedure standardized and without bias." |