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临床试验/NCT04674982
NCT04674982已完成不适用

The Effect of Vibration on Pain During Heel Lance Procedures in Newborns

University of Gaziantep1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年9月9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
入组人数
56
试验地点
1
主要终点
G Power software was used to calculate the sample size of the study.

研究概览

简要总结

This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns.

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详细描述

Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.

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
None

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Gestational age 38 and older

排除标准

  • •Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
  • •Genetic and congenital anomalies
  • •Congenital metabolic disorders,
  • •those who had undergone cardiopulmonary resuscitation,
  • •Stayed in the neonatal intensive care unit for any reason,
  • •Heel blood could not be collected at the first attempt,
  • •Osteogenesis imperfecta
  • •Had been given an analgesic within the preceding 6 hours

研究组 & 干预措施

Vibration Group

Experimental

In the vibration group, a vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) was applied to the middle/side area through which the sural nerve passes immediately below the knee of the extremity from which heel blood was to be collected approximately 30 seconds prior to commencement of the heel lance procedure. The vibration was continued throughout the heel lance procedure unless there was redness, swelling, bruising or a change in the skin integrity in the area to which the vibration was applied, and the vibration was stopped once the procedure was over.

干预措施: a vibrating device (Device)

Control Group

No Intervention

No interventions were made on the newborns in the control group during the heel lance procedure.

结局指标

主要结局

G Power software was used to calculate the sample size of the study.

时间窗: 5 days

G Power

次要结局

未报告次要终点

研究者

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

Elif BİLSİN KOCAMAZ

Assistant Professor

University of Gaziantep

研究点 (1)

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