跳至主要内容
临床试验/NCT01240044
NCT01240044已完成不适用

Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques

University of the State of Santa Catarina2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年7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
2
主要终点
Changes in cardiorespiratory parameters

研究概览

简要总结

This study intend to assess the pain intensity of newborns in neonatal intensive care unit (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The babies were categorized according to gestational age , age, weight, diagnosis, support and signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal rebalancing. Each newborn received just one physical therapy session in that they were assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The hypothesis is that newborns hospitalized in intensive care unit did not show pain when undergoing respiratory therapy.

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 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy.

排除标准

  • Newborns with contraindication of respiratory therapy, those that had problems during any of the study procedures and changes in those suffering from respiratory support or oxygen therapy during data collection.
  • If there was failure to collect any of the parameters for evaluating the newborn also was no longer part of the sample.

结局指标

主要结局

Changes in cardiorespiratory parameters

时间窗: Immediately after intervention and 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 (2)

Loading locations...

相似试验

Respiratory Therapy and Newborn Pain: Comparison... | 临床试验