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Infant Swing and Sleep-Wake Cycles

NCT ID: NCT07284303

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Sleep Quality

Keywords

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Bispectral Index Comfort Infant Swing Newborn Randomized Controlled Trial Sleep-Wake Cycle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a randomized, controlled, single-blind, two-period crossover trial conducted in a neonatal intensive care unit (NICU) in Central Anatolia, Türkiye. The study population consists of late preterm and term infants (35-42 weeks of gestation) who meet the inclusion criteria. Infants will be randomly assigned to two groups (Group A and Group B) using block randomization performed by an independent statistician. Each infant will experience both conditions - automatic swing (intervention) and standard crib (control) - in different periods according to the crossover design. The study follows the CONSORT 2010 guidelines for randomized crossover trials.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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."

Group Type EXPERIMENTAL

Care: Automatic Baby Swing

Intervention Type OTHER

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.

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."

Group Type EXPERIMENTAL

Care: Automatic Baby Swing

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.


Sudden need for resuscitation Sudden deterioration of the stabilization of health status
Minimum Eligible Age

35 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Edanur Tar Bolacali

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Edanur Tar Bolacalı, PhD

Role: CONTACT

Phone: +905332668360

Email: [email protected]

Sibel Kucukoglu, PhD

Role: CONTACT

Phone: +903322231623

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 31397094 (View on PubMed)

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.

Reference Type RESULT
PMID: 19692803 (View on PubMed)

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.

Reference Type RESULT
PMID: 34713833 (View on PubMed)

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.

Reference Type RESULT
PMID: 31366597 (View on PubMed)

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.

Reference Type RESULT
PMID: 35634367 (View on PubMed)

Other Identifiers

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SELCUK-2025-INFANTSWING

Identifier Type: -

Identifier Source: org_study_id