Health TrialsbyHealthPanel

Infant Swing and Sleep-Wake Cycles

ConditionSleep Quality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-42
SponsorKirsehir Ahi Evran Universitesi

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

gestational age between 35-42 weeks,

birth weight >2000-4200 grams,

stable health status,

spontaneous breathing,

Disqualifiers

- 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,

Trial design

Design model

Crossover

Treatments tested in this trial

  • Care: Automatic Baby Swing

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention Group 1: Automatic Baby Swing, Then IncubatorExperimental treatment 1 intervention
Group B: Intervention Group 2: Incubator, Then in the Automatic Baby SwingExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
At 0, 30, and 60 minutes.

Secondary outcomes

1

Secondary Outcome 1: Infant Body Temperature

Infant axillary body temperature measured in degrees Celsius (°C).

Time frame
At 0, 30, and 60 minutes.
2

Secondary Outcome 2: Infant Heart Rate

Infant heart rate measured in beats per minute.

Time frame
At 0, 30, and 60 minutes.
3

Secondary Outcome 3: Infant Respiratory Rate

Infant respiratory rate measured in breaths per minute.

Time frame
At 0, 30, and 60 minutes.
4

Secondary Outcome 4: Infant Oxygen Saturation

Pulse oximetry oxygen saturation measured as %SpO₂.

Time frame
At 0, 30, and 60 minutes.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirsehir Ahi Evran Universitesi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: