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Effect of Automatic Infant Swing on Sleep-Wake Cycles and Comfort: A Randomized Controlled Study Protocol
Edanur Tar Bolacali1, Fatma Ertürk2, Beyza Özcan3
1Department of Children Health and Disease Nursing, Faculty of Health Sciences, Kirsehir Ahi Evran University, Kirsehir, Turkey.
Insights
This study protocol investigates automatic infant swings for newborns in neonatal intensive care units. It aims to provide evidence on how these swings affect infant sleep-wake cycles, comfort, and physiological stability.
Area of Science:
- Neonatal Intensive Care Nursing
- Pediatric Sleep Medicine
- Infant Developmental Psychology
Background:
- Sleep-wake regulation and comfort are critical for newborn neurodevelopment and stability in NICUs.
- Evidence on non-pharmacological interventions like automatic infant swings is limited.
- This study protocol addresses this gap by evaluating automatic infant swings.
Purpose of the Study:
- To evaluate the effects of an automatic infant swing on sleep-wake cycles in newborns.
- To assess the impact of automatic infant swings on comfort behaviors and physiological parameters.
- To provide evidence for enhancing neonatal intensive care nursing practices.
Main Methods:
- A single-blind randomized controlled crossover trial involving 40 newborns (35-42 weeks gestation).
- Sleep-wake cycles assessed using the Bispectral Index (BIS) in a cot bed versus an automatic infant swing.
- Comfort behaviors and physiological parameters recorded at set intervals during 60-minute measurements.
Main Results:
- The study protocol outlines the evaluation of sleep-wake cycles using BIS.
- Comfort behaviors will be measured using the COMFORTneo scale.
- Physiological parameters will be tracked using researcher-developed charts.
Conclusions:
- This protocol will determine the effects of automatic infant swings on newborn sleep-wake cycles, comfort, and physiological parameters.
- Findings may inform neonatal care practices, offering evidence-based non-pharmacological interventions.
- The study is registered on ClinicalTrials.gov (NCT07284303).
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).
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