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临床试验/NCT07016984
NCT07016984已完成不适用

Effect of Light Intensity Reduction During Mydriasis on the Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening

Istanbul Nisantasi University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1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
90
试验地点
2
主要终点
post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups

研究概览

简要总结

Retinopathy of prematurity (ROP) screening is a routine yet painful procedure for premature infants, often necessitating pharmacological mydriasis. The associated light exposure due to dilated pupils can increase stress and reduce infant comfort. This study aimed to investigate the effect of using a phototherapy eye mask during mydriasis on the comfort levels of premature infants.

详细描述

Retinopathy of prematurity is a pathological condition affecting the developing retinal blood vessels in low birth weight premature infants and is one of the leading causes of childhood blindness. In recent years, advancements in neonatal intensive care in developing countries such as China, India, and Turkey have increased the survival rates of premature infants, consequently raising the number of infants requiring ROP screening examinations. Health Organization (WHO) recommends conducting the initial ROP examination before the infant is discharged from the hospital. However, ROP screening is a painful and stressful procedure that includes the administration of mydriatic agents, the insertion of a speculum to open the palpebral fissure, and scleral depression to visualize the retinal periphery. These interventions often result in discomfort and distress for the infant. Globally, most newborns admitted to neonatal intensive care units (NICUs) undergo repeated painful procedures. It is well-established that premature infants can perceive pain, and exposure to pain during the early stages of life may lead to long-term neurological consequences. In very preterm infants, early exposure to procedural pain has been associated with impaired cognitive development and reductions in frontal and parietal lobe volumes, brain size, white matter, and subcortical gray matter. Considering the frequency of painful interventions during hospitalization, gaining deeper insight into stress-inducing factors and exploring methods to enhance infant comfort is of great importance. Various non-pharmacological interventions-such as pacifiers, music, and oral sucrose-have been studied for their effectiveness in reducing pain and stress during ROP examinations. However, research evaluating the effect of minimizing light exposure during pupil dilation (mydriasis) is limited. Mydriatic eye drops, used to dilate the pupils for examination, are known to cause light sensitivity and photophobia. It is hypothesized that the increased light sensitivity resulting from pupil dilation before the examination contributes to infant discomfort and stress. Therefore, this study aims to investigate the effect of reducing light exposure-by applying eye patches during the mydriasis process-on the comfort levels of premature infants undergoing ROP screening.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gestational age ≤34 weeks
  • Birth weight ≤1700 grams
  • Parental consent to participate in the study

排除标准

  • Required mechanical ventilation during the study period
  • Had genetic disorders, heart disease, neurological or metabolic conditions, pulmonary anomalies, or ocular malformations
  • Had any conditions affecting the stress response
  • Were administered sedatives, muscle relaxants, corticosteroids, or analgesics
  • Had major congenital anomalies

结局指标

主要结局

post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups

时间窗: 8 hours

Statistically significant differences were observed in the total scores and all subdimensions of the PICS-alertness, calmness/agitation, crying (in non-ventilated infants), physical movement, muscle tone, facial movements, and average heart rate

次要结局

未报告次要终点

研究者

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

Alev Sivasli

Principal Investigator

Istanbul Nisantasi University

研究点 (2)

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