Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques
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
- 是
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
Camila Isabel Santos Schivinski
Dr.
University of the State of Santa Catarina
