Effect of Automatic Infant Swing on Sleep–Wake Cycles and Comfort: A Randomized Controlled Study Protocol

Background: Sleep–wake regulation and comfort are essential for neurodevelopment and physiological stability in newborns in neonatal intensive care units, yet evidence on non-pharmacological interventions such as automatic infant swings is limited. Aim: This is a study protocol which outlines a randomized controlled crossover study that aims to evaluate the effects of an automatic infant swing on sleep–wake cycles, comfort behaviours and physiological parameters in newborns in neonatal intensive care units. Study Design: The study protocol was designed as a single-blind randomized controlled crossover trial and will be conducted in the neonatal intensive care unit of a state hospital in Central Anatolia, Turkey, including newborns born between 35 and 42 weeks of gestation. Based on G*Power analysis, a total sample of 40 infants will be included and randomly assigned to group A (n = 20) or group B (n = 20) using block randomization. Newborn sleep–wake cycles will be assessed using the Bispectral Index (BIS) under two conditions: a cot bed and an automatic infant swing. Measurements will be performed four times, twice during the day and twice at night, each lasting 60 min. During each measurement period, comfort behaviours and physiological parameters will be recorded at 0, 30 and 60 min. Results: The measurements of the study outcomes will be evaluated using the ‘Information Form’, ‘Comfort Behaviour Scale (COMFORTneo)’, ‘Sleep-Wake Cycle Tracking Chart’ and ‘Physiological Parameters Tracking Chart’ developed by the researchers. Conclusions: This protocol will evaluate the effects of an automatic infant swing on newborns' sleep–wake cycles measured by BIS, with comfort behaviours and physiological parameters as secondary outcomes. Relevance to Clinical Practice: This study protocol may contribute to neonatal intensive care nursing practice by providing evidence regarding the effects of automatic infant swings on newborns' sleep–wake cycles, comfort behaviours and physiological parameters. Trial Registration: The study protocol was registered on ClinicalTrials.gov (NCT07284303).