Infant Swing and Sleep-Wake Cycles

NCT07284303 | Not Yet Recruiting

• 1 other identifier: SELCUK-2025-INFANTSWING
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Quality

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Secondary Outcome 1: Infant Body Temperature

  At 0, 30, and 60 minutes.

• Secondary Outcome 2: Infant Heart Rate

  At 0, 30, and 60 minutes.

• Secondary Outcome 3: Infant Respiratory Rate

  At 0, 30, and 60 minutes.

• Secondary Outcome 4: Infant Oxygen Saturation

  At 0, 30, and 60 minutes.

• Secondary Outcome 5: Infant Blood Pressure

  At 0, 30, and 60 minutes.

Study Arms (2)

Intervention Group 1: Automatic Baby Swing, Then Incubator

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Care: Automatic Baby Swing 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 1: Automatic Baby Swing, Then Incubator; Intervention Group 2: Incubator, Then in the Automatic Baby Swing

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Related Publications (5)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Edanur Tar Bolacalı, PhD

CONTACT

+905332668360; edanurtar.1107@gmail.com

Sibel Kucukoglu, PhD

CONTACT

+903322231623; s_nadaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 16, 2025
• Study Start: December 20, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share