跳至主要内容
临床试验/NCT06571006
NCT06571006Enrolling By Invitation不适用

Effect of Music Therapy Applied During Lumbar Puncture on Infants' Pain Perception: Randomized Controlled Study

Erzurum Technical University2 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
25
试验地点
2
主要终点
vital signs: O2 Saturation

研究概览

简要总结

Bacterial meningitis is a serious infection that is more common in newborns is associated with significant morbidity and mortality. The gold standard for the diagnosis of bacterial meningitis is a positive cerebrospinal fluid (CSF) culture, usually obtained via lumbar puncture (LP). İnfants and children have similar physiological responses to pain as adults has led to greater emphasis on the assessment and management of pain in children. Therefore, management of painful interventions is important. Music may improve oxygen saturation in preterm infants undergoing endotracheal suctioning and may also reduce stress and pain in children undergoing painful medical procedures such as intravenous injections, lumbar punctures, and dental procedures. Although there are studies in the literature examining the effect of music therapy on heel blood collection or intravenous injection, no study has been found examining the effect of music therapy on the baby's pain perception during lumbar puncture. The aim of this study is to examine whether music therapy applied during lumbar puncture affects the baby's reactions to pain.

详细描述

Bacterial meningitis is a serious infection that is more common in newborns than in other age groups and is associated with significant morbidity and mortality. The gold standard for the diagnosis of bacterial meningitis is a positive cerebrospinal fluid (CSF) culture, usually obtained via lumbar puncture (LP). Clinical suspicion of meningitis is greater in the presence of seizures, fever, swollen fontanelle, and abnormal consciousness, but initial symptoms are often vague in the neonatal period, especially in young infants. The United States and United Kingdom guidelines recommend performing LP in newborns and infants in cases of suspected sepsis and meningitis. There have been significant changes in our understanding of the pathophysiology of pain in children over the last 20 years. There is increasing evidence to suggest that neonates as young as 24 to 25 weeks of gestation have fully developed neural pathways for the transmission and perception of pain. Additionally, exposure to pain early in life can have both immediate and long-term detrimental effects on children. The realization that infants and children have similar physiological responses to pain as adults has led to greater emphasis on the assessment and management of pain in children. Therefore, management of painful interventions is important. Various studies have proven that listening to music, sounds and heartbeats can positively affect the physiological indicators, nutrition, length of stay and pain outcomes of newborn babies. Listening to music and parents' preferred lullabies can be used to objectively determine the effects of these interventions on premature newborns' heart rate, oxygen saturation, nutrient absorption, and calorie intake. Music may improve oxygen saturation in preterm infants undergoing endotracheal suctioning and may also reduce stress and pain in children undergoing painful medical procedures such as intravenous injections, lumbar punctures, and dental procedures. Although there are studies in the literature examining the effect of music therapy on heel blood collection or intravenous injection, no study has been found examining the effect of music therapy on the baby's pain perception during lumbar puncture. The aim of this study is to examine whether music therapy applied during lumbar puncture affects the baby's reactions to pain.

研究设计

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

入排标准

年龄范围
32 Days 至 40 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Having normal brainstem auditory responses
  • Gestational age between 32-40
  • Feeding the baby before the procedure
  • Implementation of LP initiative

排除标准

  • Having a genetic diagnosis
  • Having a neurometabolic diagnosis
  • Congenital malformations, mechanical ventilation, asphyxia, anomalies associated with neurological disorders, use of sedatives, or other comorbid conditions that may affect the response to musical stimuli or data collection

结局指标

主要结局

vital signs: O2 Saturation

时间窗: 40 minute

O2 Saturation Using an oximeter, arterial oxygen saturation (SaO2) will be measured and recorded from 10 minutes before the procedure until the end of the procedure. Babies' oxygen saturations will be measured with a pulse oximeter placed on the wrist and monitored. All babies in the neonatal intensive care unit are constantly monitored with a monitor device. The will be monitored and recorded using this monitor. The value will be recorded 10 minutes before the transaction, during the transaction, 10 minutes after the transaction and 20 minutes after the transaction.

vital signs: Heart rate

时间窗: 40 minute

Heart rate (beats per minute) All babies in the neonatal intensive care unit are constantly monitored with a monitor device. The babies' heart rate per minute will be monitored and recorded using this monitor. The value will be recorded 10 minutes before the transaction, during the transaction, 10 minutes after the transaction and 20 minutes after the transaction.

baby's crying duration (sec)

时间窗: 40 minute

During the procedure, the baby's crying time will be tracked and recorded in seconds.

pain reduction

时间窗: 40 minute

pain relief Neonatal Infant Pain Scale (NIPS), which is a behavioral assessment tool for measuring pain in preterm and term newborns, was developed by Lawrence et al. (1993). Cronbach's alpha value was found to be 0.95 before the procedure, 0.87 during the procedure, and 0.88 after the procedure (Lawrence et al., 1993). Turkish validity and reliability were determined by Akdovan (1999). This scale was created to measure the response of the term or preterm newborn to procedural pain or distress.Parameters include babies' facial expressions, crying, breathing patterns, arm movements, leg movements, and arousal state.The total score varies between 0 and 7. Higher scores indicate higher pain levels. In other words, as the score increases, the severity of pain also increases. 0-2 points indicate no pain/mild pain, 3-4 points indicate mild pain/moderate pain, and \>4 points indicate severe pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Metin

Assist. Prof.

Erzurum Technical University

研究点 (2)

Loading locations...

相似试验