Saeidi 2011.
Methods | Randomized controlled trial | |
Participants | 60 full term infants (80% of case group and 73.3% of control group had 40 weeks GA) Birth weight, mean ± SD, grams: 3242 ± 306.6 (intervention), 3151 ± 331.5 (control) Painful procedure: vaccination Study period: March to July 2006 |
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Interventions | Intervention: skin to skin contact 2 minutes before vaccination through 3 minutes after Control: standard care during painful procedure Provider: mother provided skin‐to‐skin care |
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Outcomes | Behavioural changes using the Neonatal/Infant Pain Scale (NIPS) 2 minutes before, during, and 3 minutes after intervention; heart rate and oxygen saturation | |
Notes | Country: Iran Power calculation: unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Samples were divided randomly into two groups." Unclear how the matching was done or how the sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information available to judge |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Neonatal reactions to pain were video recorded." Unclear whether video recording was focused on face of infant. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropout rates not reported |
Selective reporting (reporting bias) | Unclear risk | NIPS outcomes were clearly presented in Tables 1‐3; O₂ saturation presented clearly under results but specific HR and crying interval data not reported |
Other bias | Unclear risk | Power calculation not done |