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临床试验/NCT06350084
NCT06350084已完成不适用

The Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study

Burdur Mehmet Akif Ersoy University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2023年9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
120
试验地点
2
主要终点
NIPS (Neonatal Infant Pain Scale)

研究概览

简要总结

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection.

详细描述

Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.

This study is a prospective, randomized and controlled trial. In this study aim, the effect of Mother's Touch and Nurse's Therapeutic Touch applied during heel blood collection on the pain levels and crying times in newborns will be examined.

Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; Mother's Touch group, Nurse's Therapeutic Touch group, and Control group.

Data were collected using the Infant-family Information Form, NIPS-Neonatal Infant Pain Scale, and Crying Follow-up Form.

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
Single (Outcomes Assessor)

入排标准

年龄范围
2 Days 至 4 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Parents who volunteered and gave consent to participate in the research
  • Full term neonates (38-42 weeks of gestation)
  • Underwent heel stick blood drawing for routine metabolic screening
  • Aged 1 to 4 days
  • Passed the hearing screening
  • Birth weight between 2500-4400 grams
  • Parents who know how to read, write and speak Turkish.

排除标准

  • Parents with any mental problems
  • Infants with any chronic disease and congenital anomalies.

结局指标

主要结局

NIPS (Neonatal Infant Pain Scale)

时间窗: during the heel blood collection procedures (10 minutes)

It was developed in 1993 to evaluate interventional pain in newborns. Its Turkish adaptation was made in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.

次要结局

  • Crying times(during the heel blood collection procedures (average 10 minutes))
  • Processing time(during the heel blood collection procedures (average 10 minutes))

研究者

发起方
Burdur Mehmet Akif Ersoy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Ateş Beşirik

Principal Investigator

Burdur Mehmet Akif Ersoy University

研究点 (2)

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