跳至主要内容
临床试验/NCT07334652
NCT07334652Enrolling By Invitation不适用

Pain and Comfort in the Examination of Retinopathy of Prematurity

Ataturk University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
56
试验地点
1
主要终点
Procedural pain

研究概览

简要总结

This study is planned to be conducted in the Neonatal Intensive Care Unit using a double-blind, parallel-group, randomised controlled design to determine the effect of a pacifier dipped in breast milk on pain and comfort during Retinopathy of Prematurity examinations. The study will be conducted in the Neonatal Intensive Care Unit of a University Hospital in Erzurum. The sample for the study will consist of preterm infants born before 32 weeks of gestation who are receiving treatment and care at the clinic during the study period and who meet the study criteria, without using any sampling method. The power analysis for sample size indicated that at least 36 infants should be included in the study, with 18 infants in each of the experimental and control groups. The control group will undergo ROP examination in accordance with standard clinical procedures. All examinations will be performed by the same ophthalmologist. Infants in the experimental group will be fed with a pacifier dipped in breast milk, starting two minutes prior to the examination, by the same clinical nurse responsible for the infant's care, and feeding will continue until the examination is completed. Video recordings will be taken of all infants from two minutes prior to the start of the examination until two minutes after the examination. In both groups, data will be monitored and recorded using the Preterm Infant Pain Profile-Revised (PIPP-R), the Preterm Infant Comfort Scale (COMFORT neo), and vital signs before the ROP examination begins, during the examination, and after the examination.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
0 Months 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age ≤ 32 weeks
  • Birth weight ≤ 2000 grams
  • Infants undergoing their first ROP examination
  • Spontaneous breathing, not intubated,
  • Not receiving sedation
  • No congenital defects,
  • No unexplained crying,
  • No surgical intervention,
  • Parents' consent to participate in the study

排除标准

  • The presence of a condition that prevents pain assessment (intracranial haemorrhage, neurodevelopmental delay, etc.)
  • A different painful procedure performed prior to ROP (one hour)
  • Being on mechanical ventilation
  • Administration of sedative, analgesic, and anticonvulsant medication prior to examination

研究组 & 干预措施

Pacifier group

Experimental

Breast milk and dummy

干预措施: Pacifier group (Other)

Control Group

No Intervention

Routıne Procedure

结局指标

主要结局

Procedural pain

时间窗: 8-12 week

Premature Infant Pain Profile - Revision (PIPP-R)

次要结局

  • Comfort(8-12 week)

研究者

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

Türkan Kadiroğlu

Associate Professor, PhD

Ataturk University

研究点 (1)

Loading locations...

相似试验

Pain and Comfort in the Examination of Retinopathy... | 临床试验