Kostandy 2013.

Methods	Randomized Controlled Trial
Participants	36 term infants (GA 28 to 36 completed weeks) Birth weight, mean, ± SD, grams: 3358.25 (skin‐to‐skin: 3389.7 ± 333.3; Control: 3326.8 ± 324.08) Painful procedure: IM Injection Study period: July 2002 to December 2002
Interventions	Skin‐to‐skin: 10 to 15 minutes prior to, and during, heel lance Control: infant supine in bassinet 10‐15 minutes prior to heel lance
Outcomes	Cry time (seconds), Anderson Behavioural State Scale, heart rate
Notes	Country: United States Power calculation: yes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Each mother‐neonate dyad was randomly assigned using the computerized minimization method.
Allocation concealment (selection bias)	Low risk	Randomization was completed for each participant, using a minimization method calculated by a computer program. Staff could not access this information prior to group assignment.
Blinding (performance bias and detection bias) All outcomes	High risk	The nature of the intervention makes blinding study staff and participants impossible, no blinding of outcomes assessors.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All dyads completed the study
Selective reporting (reporting bias)	Low risk	All mothers and neonates enrolled in the study completed the protocol, all outcomes were reported.