Not Yet RecruitingNot Applicable

The Effect of Using Multifunctional Baby Carrier With Heart Surgery

Turkey (Türkiye)52 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range

1 Day – 3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Newborn Pain, Agitation and Sedation Scale (N PASS Scale)

Timeframe: 6 hours

Sleep-Wake Status Measurement Device (Actigraphy)

Timeframe: 6 hours

Trial details

NCT IDNCT07319858

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Aynur Baykal, Phd Student

+90 538 471 39 71 aynur.baykal10@ogr.iuc.edu.tr

View on ClinicalTrials.gov More Congenital Heart Surgery trials