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临床试验/NCT06498765
NCT06498765进行中(未招募)不适用

Effect of Pacifier Use During Phototherapy on Stress and Bilirubin Level in Newborns With Hyperbilirubinemia

Hitit University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Heart rate peak

研究概览

简要总结

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.

详细描述

After birth, fetal erythrocytes in the newborn are rapidly destroyed and the total bilirubin level increases, resulting in hyperbilirubinemia. Hyperbilirubinemia; although it is a common condition that usually occurs physiologically in newborns, it causes neurological dysfunction in the newborn when it reaches high bilirubin levels. Therefore, follow-up and treatment are important. One of the treatment approaches for hyperbilirubinemia is phototherapy.

Phototherapy treatment is applied to babies diagnosed with hyperbilirubinemia by directly giving light energy to the babies. While receiving phototherapy, the baby becomes stressed due to reasons such as the mother not being able to hold her baby in her arms, not being able to breastfeed, the baby being in a different environment such as the neonatal intensive care unit, and being exposed to invasive procedures. Individualized developmental care practices accordingly, many practices are recommended in neonatal intensive care units to reduce the stress of babies. One of these practices is non-nutritive sucking. The most commonly used method for non-nutritive sucking is the use of a pacifier. It is stated that the use of pacifiers helps the baby calm down and reduces stress in neonatal intensive care units. In 1990, the World Health Organization and the United Nations International Children's Emergency Fund determined the "Ten Steps to Successful Breastfeeding" principles for the Baby-Friendly Hospital Initiative to promote and support breastfeeding. It has been noticed that in these principles rejecting the use of pacifiers, intensive care environments where the baby is stressed and situations where the mother and the baby are separated are ignored, so it has been suggested that this situation should be brought back to the agenda. In 2013, the "Ten Steps to Successful Breastfeeding" application was revised; Considering the justified reasons for the special situations in which the newborn and the mother and the baby are separated and the situations in which the baby is stressed, the newborn The use of pacifiers has been recommended in intensive care units. Considering the 24-hour treatment period during phototherapy, the baby is separated from the mother, albeit intermittently, while receiving phototherapy. In addition, the baby is in a different environment such as the neonatal intensive care unit and is exposed to invasive procedures. All of these create stress in the baby, and pacifiers are recommended for such justified reasons. The benefits of pacifier use have been proven in neonatal intensive care units, such as calming the baby, making it easier to fall asleep, and reducing pain and stress. Another benefit of non-nutritive sucking is on the gastrointestinal system. Non-nutritive sucking stimulates oro-motor development, facilitates the development of sucking behavior and facilitates digestion in enteral feeding.

A number of enzymes and hormones are involved in facilitating digestion through non-nutritive absorption. These enzymes and hormones; lingual lipase, gastrin, insulin and motilin. Experts believe that non-nutritive sucking causes this effect through vagal stimulation of the oral mucosa. It is thought that it causes the secretion of enzymes and hormones. Non-nutritive sucking in a study reported that the use of pacifiers, one of the methods, stimulates the stomach motor functions and this facilitates the digestive process through the activation of vagal mechanisms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Term newborns
  • Newborns diagnosed with hyperbilirubinemia
  • Babies who do not use pacifiers
  • Newborns scheduled to receive phototherapy for 24 hours
  • Babies of parents who agreed to participate in the study

排除标准

  • Newborns receiving other treatments along with phototherapy
  • Newborns with a diagnosis other than hyperbilirubinemia
  • Newborns using antibiotics
  • Babies fed with formula milk or bottle
  • Babies diagnosed with pathological Hyperbilirubinemia

结局指标

主要结局

Heart rate peak

时间窗: 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.

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.

Oxygen saturation

时间窗: 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.

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.

Bowel sounds

时间窗: 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.

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.

Stress level

时间窗: 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 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.

Blood bilirubin level

时间窗: 18th and 24th hours

The blood bilirubin level of all babies observed for 24 hours, measured in line with the clinical routine, was recorded.

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahu Pınar TURAN

Principal Investigator

Hitit University

研究点 (2)

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