The Effect of Using Multifunctional Baby Carrier With Heart Surgery

Starting soon · Not applicable

Conditions studied: Congenital Heart Surgery

In brief

The study aims to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, crying, and sleep status in infants aged 0-3 months who have undergone congenital heart surgery. It is planned to be conducted in a randomized controlled crossover design. Following congenital heart surgery, the use of sedative interventions in the high-stress environment of the intensive care unit has a significant effect on preserving the energy reserves necessary for the infant's growth and development. Using a sensitive and soothing mobile crib to assist in the postoperative care of infants who have undergone congenital heart surgery is a potential opportunity for the infant, nurse, and parent. The combined application of swaddling, sound, and movement reduces the baby's fussiness and has a calming effect on their physiological activation. Infants who underwent heart surgery between 0-3 months and were followed up in a multi-purpose baby carrier (swaddling, white noise, and rocking) compared to infants in the follow-up experimental group, compared to infants in the control group who were only swaddled; Hypothesis 1: The heart rate is lower. Hypothesis 2: Blood pressure is lower. Hypothesis 3: Oxygen saturation levels are higher. Hypothesis 4: Sleep durations are longer. Hypothesis 5: Pain scores are lower.

Key facts

Study ID

NCT07319858

Run by

Istanbul University - Cerrahpasa

People needed

52

Starts

2026-06-01

Expected to finish

2028-08-01

Last updated by the study team

2026-04-21

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Babies born at 38 weeks or later
• Babies aged 0 to 3 months after birth
• No illness other than congenital heart disease
• Who has undergone surgery for the first time due to congenital heart disease
• Whose clinical condition is stable (PSOFA score below 8 points)
• Infants with stable thermoregulation

You may not qualify if…

• Babies born before 38 weeks of pregnancy
• Babies older than 3 months
• The presence of other chromosomal or neurological disorders and syndromes in the infant
• Those who have undergone two or more surgeries due to congenital heart disease
• pSOFA score above 8 points

Where it is running

• Health Sciences University Dr. Siyami Ersek Chest, Heart, and Vascular Surgery Education and Research Hospital — Istanbul, Üsküdar, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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