The Effects Of Safe Swadding On Newborns' Oxygen Saturation And Comfort Level

The population of the study consisted of preterm newborns receiving treatment in the Tertiary Neonatal Intensive Care Unit of X University Medical Faculty Hospital. Preterm babies between 30-36 weeks of gestation were included in the sample. The sample size of the study was accepted as type 1 error probability (α) 0.05 (95% confidence level) and type 2 error probability (β) 0.10 (80% power level), taking into account the known score in the G*Power 3.1.5 program. The sample size was determined as 32 for each group. However, since it was thought that there might be loss during the analysis, it was planned to reach 35 newborns for each group. As a result of the study, a total of 70 preterm newborns who met the inclusion criteria were reached.

Randomization The distribution of the newborns included in the study into groups was created by a statistician using codes obtained from a permutation-based computer program and stratified according to gestational age. The groups represented by the letters were determined at the beginning of the study using the closed opaque envelope method. As a result of the draw, it was decided that the letter A would represent the control group, and the letter B would represent the safe swaddling group. A single-participant blinding was applied in the study. A separate informed consent form was created and approved for each group. Thus, each newborn parent received information only about the intervention that would be applied to him/her. Randomization was followed according to the CONSORT 2010 diagram.

Hypotheses H1: Safe swaddling applied to preterm newborns has an effect on mean comfort scores.

H2: Safe swaddling applied to preterm newborns has an effect on oxygen saturation.

Data Collection Tools The study data were collected using the Information Form, Neonatal Comfort Behavior Scale (COMFORTneo), Neonatal Bedside Monitor, and Histogram Tracking Form.