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临床试验/NCT07350980
NCT07350980已完成不适用

The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters; A Randomized Controlled Study.

Sakarya University0 个研究点目标入组 120 人开始时间: 2025年6月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120

研究概览

简要总结

One of the most common and painful procedures in newborns is taking a capillary blood sample from the heel. This basic procedure, widely used in early health assessments, particularly in newborn screening tests, can cause mild to moderate pain.While both pharmacological and non-pharmacological approaches are used in pain management in newborns, the primary goal is to minimize and prevent painful stimuli as much as possible. Non-pharmacological methods are preferred in newborn care because they have no side effects, are easy to apply, low-cost, and caregiver-friendly.

详细描述

This study was designed as a prospective, three-arm, parallel-group randomized controlled trial. It focused on non-pharmacological methods (lavender oil, mandarin oil, control group/standard care).Mothers of newborns meeting the recruitment criteria were informed of the study before heel prick testing and provided verbal and written consent. The standard approach involves performing heel prick testing on all newborns in their mothers' arms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Gestational age between 38-42 weeks,
  • APGAR score of 7 or higher at 5 minutes,
  • Neither mother nor baby should have used sedatives, tranquilizers, or anticonvulsants in the last 24 hours,
  • Heel prick blood should be planned as part of the routine neonatal screening program,
  • No blood should be taken from the heel prick for any other reason before the procedure,
  • Parents should voluntarily participate in the study.

排除标准

  • Gestational age of 37 weeks or less,
  • APGAR score of 6 or lower at 5 minutes,
  • Having a diagnosed lung disease,
  • Having a history of atopic dermatitis, hypersensitivity, or allergies,
  • Parents should not wish to participate in the study.

研究者

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

öznur tiryaki

Associate Professor

Sakarya University

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