Pacifier Use During Phototherapy in Newborns With Hyperbilirubinemia
NCT Number: NCT06498765
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Newborn Jaundice|Pacifier
Interventions: OTHER: Pacifier Use
Sponsor: Hitit University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-06-01
Completion Date: 2025-02-01
Locations: Istanbul University Cerrahpaşa, Istanbul, 34000, Turkey

Summary:
Hyperbilirubinemia; It is a common condition that usually occurs physiologically in newborns. Phototherapy is used in the treatment of hyperbilirubinemia. Babies cry while receiving phototherapy, the mother's inability to hold her baby in her arms, her inability to breastfeed, and the invasive procedures (bloodletting) stress the baby. Pacifiers are used among individualized developmental care practices to calm the baby and reduce stress. Another benefit of pacifiers for the baby is on the gastrointestinal system. Non-nutritive sucking stimulates oro-motor development, facilitates the development of sucking behavior and facilitates digestion in enteral feeding. Considering all these benefits, this study aimed to determine the effect of pacifier use during phototherapy on stress and bilirubin levels in newborns with hyperbilirubinemia.

Primary Outcome Measures: Heart rate peak, The heart rate of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed., mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.|Oxygen saturation, The oxygen saturation of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed., mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.|Bowel sounds, The bowel sounds of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist.The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed., mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.|Stress level, Stress level in babies is evaluated with the "Newborn Stress Scale", whose Cronbach's alpha coefficient is between 0.65-0.81. The scale is a 3-point Likert type with a total of 24 items consisting of 8 sub-dimensions: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture. The items in the scale are graded according to the stress level and classified into 8 subgroups. Each subgroup is evaluated between 0-2 points, and a minimum of 0 and a maximum of 16 points are obtained from the scale. A score of 0 from the baby indicates that the baby's condition is stable and balanced. A high total score on the scale indicates that the baby's stress level is high. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed., mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.|Blood bilirubin level, The blood bilirubin level of all babies observed for 24 hours, measured in line with the clinical routine, was recorded., 18th and 24th hours