Akcan 2009.
| Methods | Randomized controlled trial | |
| Participants | 50 preterm infants (PMA 31.6 ± 2.0 weeks) Postnatal age, mean ± SD, days: 4.7 ± 4.4 (total), 4.9 ± 4.3 (intervention), 4.6 ± 4.5 (control) Birth weight, mean ± SD, grams: 1669 ± 530 (total), 1577± 491 (intervention), 1762 ± 561 (control) Painful procedure: heel lance or venepuncture Study period: February 2006 to December 2006 |
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| Interventions | Intervention: 45 minutes of uninterrupted skin‐to‐skin every day for 5 days, with the painful procedure carried out on the 5th day Control: standard care during painful procedure Provider: mother |
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| Outcomes | PIPP score at 1st, 2nd, and 3rd minute of painful procedure PIPP score 1st and 2nd minute after painful procedure |
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| Notes | Country: Turkey Power calculation: no |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The infants were chosen for the groups using a random method by drawing out of a thick, non‐transparent envelope." Random method was not clearly described |
| Allocation concealment (selection bias) | Unclear risk | "The infants were chosen for the groups using a random method by drawing out of a thick, non‐transparent envelope." It is unclear whether the envelopes were sealed or numbered sequentially and if each individual participant was given an envelope or if group assignment was drawn from one envelope |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | "The mothers put on a gown leaving the chest area open and the infant was placed between the mother’s breasts with head upright to provide the greatest surface area for skin contact." "The video recordings and monitor records of the infants in both groups were analyzed by three experts (neonatology nurse, neonatologist and anaesthesiologist) who were totally blind to the study." Not clear if camera recording focused only on infants' faces or if mothers' skin/breasts could be noted by researchers |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "A total of 100 infants dropped out of the study (91 discharged within 5 days of admission, mothers of 6 infants could not come to the unit regularly, and 3 mothers did not agree to implement KC). As a result, 50 infants comprised the sample, with 25 allocated to the KC group and the other 25 to the control group." Data were presented for all participants assigned to intervention and control groups. There is variability in the length of procedure (mean 1 minute for heel lance, 2.5 minutes for venepuncture) and authors do not report how this is addressed in analysis (e.g. number of infants in each time point, adjustment for procedure duration). |
| Selective reporting (reporting bias) | Low risk | Methods section reported that infants' behavioural responses to pain and physiologic variables, such as heart rate and oxygen saturation, were monitored and recorded. Although these outcomes compose the PIPP score, they were not individually reported or mentioned in the discussion |
| Other bias | Low risk | "Method of delivery, sex, postmenstrual age, birth weight, receipt of oxygen support prior to the procedure, or PIPP scores before or after the invasive procedure were similar (P > 0.05) in both groups." Study was apparently free from other sources of bias |