The Effect of Using Multifunctional Baby Carrier With Heart Surgery
1 other identifier
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 1, 2028
April 21, 2026
April 1, 2026
1.2 years
December 20, 2025
April 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6 hours
Sleep-Wake Status Measurement Device (Actigraphy)
It is used to monitor babies' sleep-wake cycles.
6 hours
Secondary Outcomes (1)
Pediatric Sequential Organ Failure Assessment Score (pSOFA)
6 hours
Study Arms (2)
Group A
ACTIVE COMPARATORGroup 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)
Group B
ACTIVE COMPARATORGroup 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)
Interventions
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Sciences University Dr. Siyami Ersek Chest, Heart, and Vascular Surgery Education and Research Hospital
Istanbul, Üsküdar, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Birsen Mutlu, Assc prof
Istanbul University - Cerrahpasa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD STUDENT
Study Record Dates
First Submitted
December 20, 2025
First Posted
January 6, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
The consent forms stated that the confidentiality of the information would be protected and that it would be used only for the evaluation of the data in this study without identifying information.