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临床试验/NCT06111534
NCT06111534已完成不适用

Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates: A Quasi-experimental Study

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2016年2月4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
92
试验地点
2
主要终点
Neonatal Infant Pain Scale (NIPS)

研究概览

简要总结

This study investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates

详细描述

Newborns undergo many painful procedures. The heel prick, or heel lancing, is a painful procedure used for newborn screening tests. It is a more painful procedure than other venipuncture procedures. All pediatricians and healthcare professionals working with neonates should focus on pain management during heel pricks for two reasons. First, they are under an ethical obligation to help neonates experience as little pain as possible during medical procedures. Second, repeated painful exposure has harmful consequences. The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) also recommends pharmacological and non-pharmacological methods to prevent and effectively manage acute procedural pain in children. However, pharmacological methods for pain management in neonates may have some side effects. On the other hand, non-pharmacological methods are easy to use, affordable, and time-effective methods with no side effects. Healthcare professionals do not use non-pharmacological methods that are expensive, hard to apply, and time-consuming. Therefore, this study focused on maternal holding-cuddling and paternal holding-cuddling as alternative non-pharmacological methods to prevent procedural pain in neonates during heel pricks. Holding-cuddling is an effective non-pharmacological method for reducing procedural pain.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
38 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • healthy term neonates
  • birth weight between 2500 and 4000 g
  • 38-42 gestational week
  • postnatal age of 48-72 hours
  • a 5-minute APGAR score of ≥8,
  • having had no experience of any painful interventions other than vitamin K and hepatitis B vaccine at birth
  • fed between 30 and 60 min before the procedure
  • undergoing heel prick only once
  • blood collection for the Guthrie test
  • willing to hold their babies during the procedure

排除标准

  • sleeping during the procedure
  • receiving analgesics up to 24 hours before the procedure

结局指标

主要结局

Neonatal Infant Pain Scale (NIPS)

时间窗: Through painful procedure completion, an average of 10 minutes

The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.

次要结局

  • Crying time after the procedure(Through painful procedure completion, an average of 2 minutes)
  • Crying time during the procedure(Through painful procedure completion, an average of 2 minutes)

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 (2)

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