Infant Swing and Sleep-Wake Cycles

Official title

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

Overview

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.

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.

Interventions

• 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 parame

Primary outcome measures

• Primary Outcome 1: COMFORTneo Total Score [Time frame: At 0, 30, and 60 minutes.]

Secondary outcome measures (5)

• Secondary Outcome 1: Infant Body Temperature [Time frame: At 0, 30, and 60 minutes.]
• Secondary Outcome 2: Infant Heart Rate [Time frame: At 0, 30, and 60 minutes.]
• Secondary Outcome 3: Infant Respiratory Rate [Time frame: At 0, 30, and 60 minutes.]
• Secondary Outcome 4: Infant Oxygen Saturation [Time frame: At 0, 30, and 60 minutes.]
• Secondary Outcome 5: Infant Blood Pressure [Time frame: At 0, 30, and 60 minutes.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 31397094
• 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. PMID 19692803
• 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. PMID 34713833
• 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. PMID 31366597
• 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. PMID 35634367
• Bolacali ET, Erturk F, Ozcan B, Kucukoglu S. Effect of Automatic Infant Swing on Sleep-Wake Cycles and Comfort: A Randomized Controlled Study Protocol. Nurs Crit Care. 2026 Jul;31(4):e70570. doi: 10.1111/nicc.70570. PMID 42429091

Identifiers

NCT: NCT07284303 · SELCUK-2025-INFANTSWING

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗