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临床试验/NCT06610656
NCT06610656已完成不适用

The Effect of White Noise and Pacifier Applications on Pain and Crying Time in Newborns in the Postoperative Period

Yuksek Ihtisas University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
1. Neonatal Pain Scale (NIPS

研究概览

简要总结

The study was conducted to determine the effect of white noise and pacifier applications on pain and crying time during painful interventions in newborns who underwent surgery

详细描述

Newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. This result implies that newborn or child pain should be adequately managed. Thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. Managing this pain in newborns should be one of the primary duties of newborn nurses. The first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. Many non-pharmacological methods are used to manage pain that may occur in interventional procedures. Some of these methods are: giving sugar solution, kangaroo care, positioning (Kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. Two other effective methods are non-nutritive suction and white noise. As a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. Within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. By examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

n this study, both participants and investigators are masked to the group assignment. Participants will not be aware of whether they are receiving pacifier therapy alone or in combination with white noise therapy. Investigators will not know the specific group assignments during the intervention to minimize bias in observations and assessments.

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

  • Birth weight over 1500 grams
  • Having passed the newborn hearing screening test
  • Having a history of previous surgery (excluding brain surgeries)
  • Not using sedative substances (dormicum, fentanyl)
  • Not using opioids
  • Having a full stomach 30 minutes before painful interventions
  • Having permission from their mothers
  • Newborns undergoing blood transfusion only

排除标准

  • Being intubated
  • Having hiberbilirubinemia
  • Birth weight below 1500 grams
  • Having cerebral palsy
  • Having hydrocephalus
  • Having spina bifida
  • Having had brain surgery

结局指标

主要结局

1. Neonatal Pain Scale (NIPS

时间窗: 20 minutes

The factors evaluated in the newborn baby pain scale are facial expression, arms, legs, oxygen saturation, arousal, breathing pattern, crying, heart rate. It can be preferred in post-operative pain. It can be used in procedural pain. It has a total of 8 parameters. The highest score can be given is 7. 0 points = no pain, 1-2 points = mild pain, 3-4 points = moderate pain, \>4 points = severe pain is accepted.

次要结局

未报告次要终点

研究者

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

Arzu Bahar

Associate Pofessor

Yuksek Ihtisas University

研究点 (2)

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