This study protocol outlines a single-blind randomized controlled crossover trial 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.
Key Findings
Methods
The study is designed as a single-blind randomized controlled crossover trial examining automatic infant swings as a non-pharmacological intervention in NICUs.
The trial will be conducted in the neonatal intensive care unit of a state hospital in Central Anatolia, Turkey.
The crossover design means each infant will be assessed under two conditions: a standard cot bed and an automatic infant swing.
The study is registered on ClinicalTrials.gov (NCT07284303).
The protocol targets newborns born between 35 and 42 weeks of gestation.
Methods
A total sample of 40 infants will be included, determined by G*Power analysis, and randomized using block randomization.
Infants will be randomly assigned to group A (n = 20) or group B (n = 20).
Block randomization will be used to assign participants to groups.
The sample size of 40 was determined through G*Power analysis to ensure adequate statistical power.
Methods
Sleep-wake cycles will be assessed using the Bispectral Index (BIS) as the primary outcome measure.
BIS monitoring will be used to objectively measure newborn sleep-wake cycles under both cot bed and automatic infant swing conditions.
Measurements will be performed four times total, twice during the day and twice at night.
Each measurement period will last 60 minutes.
The use of BIS for sleep-wake cycle assessment represents an objective neurophysiological measurement approach in this neonatal population.
Methods
Comfort behaviours and physiological parameters will be recorded as secondary outcomes at three time points within each measurement period.
Comfort behaviours and physiological parameters will be recorded at 0, 30, and 60 minutes during each measurement period.
Comfort behaviours will be assessed using the Comfort Behaviour Scale (COMFORTneo).
Additional data collection tools include an 'Information Form', a 'Sleep-Wake Cycle Tracking Chart', and a 'Physiological Parameters Tracking Chart' developed by the researchers.
Background
The protocol identifies sleep-wake regulation and comfort as essential for neurodevelopment and physiological stability in NICU newborns, with limited existing evidence on automatic infant swings.
The authors note that evidence on non-pharmacological interventions such as automatic infant swings is limited.
The protocol frames the automatic infant swing as a non-pharmacological intervention.
The authors state the study '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.'
What This Means
This paper describes the design of a clinical study — not yet completed results — that will test whether placing premature and full-term newborns in an automatic rocking infant swing (compared to a standard hospital cot) improves their sleep patterns, comfort, and physical stability while in the neonatal intensive care unit (NICU). Forty newborns born between 35 and 42 weeks of pregnancy will participate, each experiencing both conditions (the cot and the swing) so that direct comparisons can be made. Sleep quality will be measured using a brain-monitoring device called a Bispectral Index monitor, which provides an objective, real-time measure of brain activity related to sleep and wakefulness, with comfort and vital signs also tracked at regular intervals.
This research suggests that automatic infant swings might serve as a practical, drug-free tool for NICU nurses to help newborns sleep better and remain more comfortable during a critical period of brain development. Currently, there is little scientific evidence about whether these devices are safe or effective in hospital settings, so this study is designed to fill that gap. The crossover design — where each baby serves as their own comparison — is a rigorous approach that helps account for differences between individual infants.
If the completed study finds that the swing improves sleep and comfort without disrupting physiological stability, it could inform NICU nursing protocols and give healthcare teams an additional evidence-based option for supporting vulnerable newborns without medication. However, it is important to note that this paper only describes the study plan; the actual results have not yet been reported.
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Bolacali E, Ertürk F, Özcan B, Kücükoğlu S. (2026). Effect of Automatic Infant Swing on Sleep-Wake Cycles and Comfort: A Randomized Controlled Study Protocol.. Nursing in critical care. https://doi.org/10.1111/nicc.70570