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临床试验/NCT06959290
NCT06959290已完成不适用

Effect of Multiple Non-pharmacological Methods for Pain Management During Eye Examination for Retinopathy of Prematurity in Preterm Infants: A Randomised Controlled Crossover Trial

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)

研究概览

简要总结

This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).

详细描述

Retinopathy of prematurity (ROP) examination is performed using a binocular indirect ophthalmoscope. ROP examination causes pain and discomfort in the preterm infant in many ways, including the application of eye drops, the placement of the speculum in the eye, the pressure applied to the pupils and the brightness of the ophthalmoscope. Studies in the literature have also reported that newborns experience pain and discomfort during ROP examination. In relation to the ROP pain experienced by the preterm infant, various physiological changes such as increased heart rate or decreased oxygen saturation are experienced during or after the examination. Accordingly, ROP examination is important; however, controlling the pain that occurs during the examination is also very important in terms of the patient's emotional experience and comfort. In the literature, many studies have been conducted to reduce pain during ROP examination. Although pharmacological treatment methods are an effective technique to reduce pain, it is recommended that nonpharmacological methods should be used especially in infants and children because of the side effects of drugs (such as apnoea, bradycardia, respiratory depression, hypotension) and the method to be used should be easy, fast and does not require preparation. The Turkish Neonatology Society and the Turkish Ophthalmology Society also recommend that ROP examination is a very painful procedure, that pharmacological methods alone are not sufficient to reduce pain, and that nonpharmacological methods such as pacifier, breast milk and oral sucrose should be used during the examination. In addition, although there is no gold standard for pain relief during ROP examination, previous studies suggest that clinicians should use more than one method together to reduce pain and provide relief in premature infants. In this study, a combination of oral 25% dextrose, non-nutritive sucking and swaddling will be used for multiple nonpharmacological applications

研究设计

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

入排标准

年龄范围
26 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Postmenstrual gestational age ≤32 weeks and/or birth weight ≤1500 g,
  • •Stable, awake, in supine position and breathing spontaneously without oxygen support,
  • •Vital signs were within normal limits before the examination,
  • •Premature infants undergoing ROP examination for the first time.

排除标准

  • •Preterms who have been administered non-steroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital and diazepam within 24 hours before the ROP examination,
  • •Preterms with severe respiratory diseases, receiving respiratory support (continuous positive airway pressure or mechanical ventilation),
  • •Preterms with critical conditions such as central nervous system infections and sepsis,
  • •Preterms with other organic diseases such as severe cardiovascular disease, pulmonary insufficiency,
  • •Preterms with congenital malformations.

研究组 & 干预措施

Control Group

Sham Comparator

Retinopathy of prematurity examination will be performed according to clinical routine practice.

干预措施: Routine Treatment (Other)

Intervention Group

Active Comparator

Multiple nonpharmacological methods will be applied for pain management during retinopathy of prematurity examination.

干预措施: Multiple nonpharmacological methods (Procedure)

结局指标

主要结局

Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R)

时间窗: 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure

The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of \<7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.

次要结局

  • Oxygen saturation(1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure)
  • Heart rate(1 minute before the procedure, iduring the procedure, 2 minutes after the procedure and 5 minutes after the procedure)

研究者

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

Aynur Aytekin Ozdemir

Professor

Istanbul Medeniyet University

研究点 (1)

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