Infant Swing and Sleep-Wake Cycles (AISS)

Effect of an Automatic Infant Swing on Sleep-Wake Cycles, Comfort Behaviors, and Physiological Parameters in Newborns: A Randomized Controlled Trial

This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Quality
• Intervention / Treatment: Other: Care: Automatic Baby Swing

Detailed Description

Sleep patterns and behavioral comfort during the neonatal period are important indicators of neurological development and physiological stability. However, noise, light, and constant medical interventions and care practices in the NICU environment can negatively affect infants' sleep continuity and quality of rest. Therefore, non-pharmacological approaches that provide sensory support, such as rhythmic and gentle rocking, are thought to be effective in promoting infant relaxation and physiological balance. In this study, an automatic baby swing with adjustable speed and rhythm will be used as an intervention to support infant comfort and sleep organization. Clinically stable term and preterm newborns who meet the specified inclusion criteria will be included in the study. Participants will be randomly assigned to two groups: the intervention group (first automatic swing application, then measurement without the swing) and the control group (first measurement without the swing, then measurement in the automatic baby swing). The intervention will be implemented for 60 minutes after daytime care at 9:00 AM and 12:00 PM, and for 60 minutes after nighttime care at 9:00 PM and 12:00 AM. The infants' BIS values, comfort, and physiological parameters will be monitored throughout the entire process. The study will evaluate the infants' sleep-wake cycles, comfort behaviors (e.g., facial expressions, body movements, crying), and physiological parameters (e.g., heart rate, respiratory rate, oxygen saturation) as outcome variables. Data will be collected using standardized observation forms and monitoring devices. This study is expected to contribute to evidence-based nursing practice by demonstrating the effects of movement-based nonpharmacological interventions on newborn comfort, sleep quality, and physiological stability.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edanur Tar Bolacalı, PhD; Phone Number: +908504412483 +905332668360; Email: edanurtar.1107@gmail.com
• Study Contact Backup: Name: Sibel Kucukoglu, PhD; Phone Number: +903322231623; Email: s_nadaroglu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• gestational age between 35-42 weeks,
• birth weight >2000-4200 grams,
• stable health status,
• spontaneous breathing,
• no sedation,
• parental volunteering to participate in the study.

Exclusion Criteria:

• - A 5-minute APGAR score below 4 at birth,
• Requirement of resuscitation,
• Presence of a congenital anomaly,
• Requirement of interventional intervention in the head region,
• Presence of central nervous system dysfunction,
• Presence of postpartum medical complications.

Exclusion Criteria (during the research):

Sudden need for resuscitation Sudden deterioration of the stabilization of health status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group 1: Automatic Baby Swing, Then Incubator; The sleep, comfort, and physiological parameters of the babies in Group 1 will be assessed day and night, "First in the Automatic Baby Swing, Then in the Incubator."	Other: Care: Automatic Baby Swing; The Automatic Baby Swing aims to calm the baby by mimicking their natural movements. In this study, the low-speed "Rock-a-Bye" mode will be used because it mimics natural parental movements, making it easier for babies to fall asleep. During the implementation phase: After the baby's general condition is checked, the treatment will begin according to the group to which they were randomly assigned. If the baby is assigned to the Automatic Baby Swing, their sleep, comfort, and physiological parameters will be measured "First in the Automatic Baby Swing, Then in the Incubator" for 60 minutes during the day and night. If the baby is assigned to the other group, their sleep, comfort, and physiological parameters will be measured "First in the Incubator, Then in the Automatic Baby Swing" for 60 minutes during the day and night.
Experimental: Intervention Group 2: Incubator, Then in the Automatic Baby Swing; The sleep, comfort, and physiological parameters of the babies in Group 2 will be assessed day and night, "First in the Incubator, Then in the Automatic Baby Swing."	Other: Care: Automatic Baby Swing; The Automatic Baby Swing aims to calm the baby by mimicking their natural movements. In this study, the low-speed "Rock-a-Bye" mode will be used because it mimics natural parental movements, making it easier for babies to fall asleep. During the implementation phase: After the baby's general condition is checked, the treatment will begin according to the group to which they were randomly assigned. If the baby is assigned to the Automatic Baby Swing, their sleep, comfort, and physiological parameters will be measured "First in the Automatic Baby Swing, Then in the Incubator" for 60 minutes during the day and night. If the baby is assigned to the other group, their sleep, comfort, and physiological parameters will be measured "First in the Incubator, Then in the Automatic Baby Swing" for 60 minutes during the day and night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome 1: COMFORTneo Total Score	The COMFORTneo scale assesses seven behavioral and physiological parameters (muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying). These parameters will be combined to produce a single total score (range 6-30). Only the total score will be reported.	At 0, 30, and 60 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome 1: Infant Body Temperature	Infant axillary body temperature measured in degrees Celsius (°C).	At 0, 30, and 60 minutes.
Secondary Outcome 2: Infant Heart Rate	Infant heart rate measured in beats per minute.	At 0, 30, and 60 minutes.
Secondary Outcome 3: Infant Respiratory Rate	Infant respiratory rate measured in breaths per minute.	At 0, 30, and 60 minutes.
Secondary Outcome 4: Infant Oxygen Saturation	Pulse oximetry oxygen saturation measured as %SpO₂.	At 0, 30, and 60 minutes.
Secondary Outcome 5: Infant Blood Pressure	Non-invasive systolic and diastolic blood pressure measured in mmHg.	At 0, 30, and 60 minutes.

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi

Publications and helpful links

General Publications

• van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
• Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
• Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
• Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.
• Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Newborn; Comfort; Bispectral Index; Infant Swing; Sleep-Wake Cycle
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SELCUK-2025-INFANTSWING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No