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临床试验/NCT01255176
NCT01255176已完成不适用

Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants

University of the State of Santa Catarina1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年1月1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
60
试验地点
1
主要终点
Changes in cardiorespiratory parameters

研究概览

简要总结

It gave a clinical trial which will be included in the 60 infants, aged up to 24 months, diagnosed with congenital's population will be divided by simple randomization into three groups: 20 infants in the intervention group, 20 infants in the control group, not receive the RTA technique and another 20 infants in a placebo group, we just get the support manual therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory rate and oxygen saturation. Then the researcher will apply three specific rating scales, based on clinical presentation and behavior of infants. Hypothesis: The RTA improves cardiorespiratory parameters and reduces signs of discomfort and pain of infants with congenital heart acyanogenic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
1 Day 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns admitted to the nursery without ventilatory support or oxygen therapy, and whose parents agree with the child's participation in the study. Will be excluded newborns who have some problems during any of the study procedures and those whose condition will change after the intervention, with shift in ventilatory support or oxygen therapy.

排除标准

  • In case of inability to collect some of the parameters evaluated at the appropriate time, the RN also will no longer part of the sample, as well as those who show no contraindication to therapy.

结局指标

主要结局

Changes in cardiorespiratory parameters

时间窗: 15 minutes after the end of the intervention

Pain Scales (NIPS, PIPP, NFCS)

时间窗: Immediately after intervention and 15 minutes after the end of the intervention

次要结局

未报告次要终点

研究者

发起方
University of the State of Santa Catarina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Camila Isabel Santos Schivinski

Dr.

University of the State of Santa Catarina

研究点 (1)

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