The Effect of Using Multifunctional Baby Carrier With Heart Surgery
NCT ID: NCT07319858
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2026-01-31
2028-03-31
Brief Summary
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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.
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Detailed Description
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The sample size for the study, which is a 2x2 crossover design, was calculated using power analysis a large effect size and 80% power, resulting in a sample size of 52. Infants will be assigned to groups using simple randomization.
The dependent variables of the study are the infant's heart rate, blood pressure, oxygen saturation, sleep status, pain scale score, and crying duration. The independent variables are: the baby's gender, the baby's age, the postoperative day, the time spent at home with the parent, swaddling, white noise, and rocking.
Research groups: 1. Swaddling group (control), 2. Swaddling combined with rocking and white noise feature in a multifunctional primary cradle group.
In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders.
The data collection tools used in the study were the Infant Information Form, Infant Intervention Monitoring Form, Neonatal Pain, Agitation, and Sedation Scale (N PASS), Pediatric Sequential Organ Failure Assessment Score (pSOFA), Informed Consent Form-Parent Form, monitor , actigraph, stopwatch, decibel meter, swaddling cloth, and multi-functional baby carrier crib will be used as data collection tools in the study. Research data will be analyzed using the Statistical Package for Social Sciences (SPSS) program.
The safety of patients' vital sign data will be ensured through graphs. Pain assessment using the N-PASS scale will be evaluated by the same two observers, and inter-observer agreement will be examined.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders. 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.
TREATMENT
NONE
Study Groups
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Group A
Group A (26 babies) :
1. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)
2. Monitoring in an open incubator for the next 3 hours (control)
Multifunctional Baby Carrier
The 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)
Group B
Group B (26 babies) :
1. Monitoring in an open incubator for the next 3 hours (control)
2. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)
Multifunctional Baby Carrier
The 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)
Interventions
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Multifunctional Baby Carrier
The 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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Day
3 Months
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Aynur Baykal
PHD STUDENT
Principal Investigators
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Birsen Mutlu, Assc prof
Role: STUDY_DIRECTOR
Istanbul University - Cerrahpasa
Locations
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Health Sciences University Dr. Siyami Ersek Chest, Heart, and Vascular Surgery Education and Research Hospital
Istanbul, Üsküdar, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IUC-PHD-NURS-2025-01
Identifier Type: -
Identifier Source: org_study_id
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