The Effect of Using Multifunctional Baby Carrier With Heart Surgery
ConditionCongenital Heart Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Multifunctional Baby Carrier
Other interventionThe study will be conducted using a randomized controlled crossover design. Infants will be assigned to either group A or group B using a simple randomization method. The infant will be assigned to the control and experimental groups according to the order of initiation within the group to which the infant belongs. Since the study is cross-over in design, infants in both groups (Group A and Group B) will be included in both the experimental group and the control group. Each baby will be monitored for a total of 6 hours. Group A (26 babies): 1. Monitoring in a multifunctional main cradle during the first 3 hours (experiment) 2. Monitoring in an open incubator wrapped for the second 3 hours (control) Group B (26 babies): 1. Monitoring in an open incubator wrapped for the second 3 hours (control) 2. Monitoring in a multifunctional main cradle during the first 3 hours (experiment)
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Newborn Pain, Agitation and Sedation Scale (N PASS Scale)
Term and preterm newborns are used for the purpose of evaluating postoperative pain/agitation and sedation. The total pain score ranges from 0 to +11. A high score indicates significant pain.
Time frame
6 hours2
Sleep-Wake Status Measurement Device (Actigraphy)
It is used to monitor babies' sleep-wake cycles.
Time frame
6 hoursSecondary outcomes
1
Pediatric Sequential Organ Failure Assessment Score (pSOFA)
It is used to measure the severity of the disease and determine mortality. The lowest score is 0 and the highest score is 28 points. It is stated that mortality increases as the score increases. The Pediatric Sequential Organ Failure Assessment Score cutoff point distinguishing mortality is specified as 8 points. For this reason, infants with a pSOFA score below 8 points will be included in our study.
Time frame
6 hoursSponsors and contacts
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Source ClinicalTrials.gov
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