Aim: The aim of this study is to investigate the effectiveness of the bladder stimulation technique (BST) to collect urine samples from newborns and its effects on physiological parameters and comfort of the newborn.

Design: This was a randomized controlled trial conducted in a NICU. A total of 64 newborns were divided into 2 groups: 32 newborns in the experimental group and 32 newborns in the control group.

Methods: Newborns in the experimental group (EG) were subjected to the BST, and in the control group (CG), urine collection was via sterile urine bags, which is routine practice. Procedural success was defined as the collection of urine samples within 3 min of beginning the stimulation technique in the experimental group and of placing the sterile urine bag in the control group.

Results: The success rate of the procedure in 3 min was 62.5% in the EG and 28% in the CG (P = 0.006, absolute difference: 35%, 95% confidence interval 27% to 42%, NNT: 3). According to the comparison of the overall mean COMFORTneo scale and pain and distress subscale scores at the 1- and 3-min marks, there was a significant difference between the EG and CG (p < 0.05). The mean scores in the EG were higher than those in the CG. The mean oxygen-saturation was significantly lower in the EG than in the CG (p < 0.05), and the increase in heart rate was significantly higher in the EG (p = 0.018).

Conclusions: BST is a more successful method within 3 min for collecting urine samples from newborns compared to sterile urine bags. However, the newborns' comfort levels minimally decreased at 3 min, and they had moderate pain and distress, while the BST was being implemented. This increase in physiologic parameters was statistically significant but not clinically significant.

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