Infant Swing and Sleep-Wake Cycles (AISS)

Kirsehir Ahi Evran Universitesi

Status: Not yet enrolling

Conditions: Sleep Quality

Treatments: Other: Care: Automatic Baby Swing

Study type: Interventional

Funder types: Other

Identifiers

NCT07284303

SELCUK-2025-INFANTSWING

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intervention Group 1: Automatic Baby Swing, Then Incubator

Experimental group

Description:

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."

Treatment:

Other: Care: Automatic Baby Swing

Intervention Group 2: Incubator, Then in the Automatic Baby Swing

Experimental group

Description:

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."

Treatment:

Other: Care: Automatic Baby Swing