NCT07319858

The Effect of Using Multifunctional Baby Carrier With Heart Surgery

The Effect of Using Multifunctional Baby Carrier on Physiological Parameters, Pain and Sleep Status in Babies With Heart Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 1 Day – 3 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This thesis study was designed to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, pain, crying, and sleep status in infants aged 0-3 months who underwent congenital heart surgery. 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

• Congenital Heart Surgery

Interventions

Type	Name	Description
OTHER	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)

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-01-06
• Last updated: 2026-01-09

Locations

1 site across 1 country: Turkey (Türkiye)