NCT01731834已完成早期 1 期
Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques
Federal University of Uberlandia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assess whether there is pain in children when performed randomized technique
研究概览
简要总结
There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.
详细描述
Randomization to 10 children and 10 vibrocompression for aspiration of secretion.
Fill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during and after the technique performed).
Photographic Record (rest, during and after the technique performed). Saliva Collection (rest, 5, 20 and 40 minutes after running technics). Data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of Respiratory Therapy
- •Fasting for one hour before the moment of collection
- •Term of Free and Informed Consent Form (ICF) signed by parents or legal guardians
排除标准
- •Children in postoperative period acute
- •Presence of thoracic drain or mediastinal
- •Children using drugs to sedative or analgesic purpose of deep sedation
结局指标
主要结局
Assess whether there is pain in children when performed randomized technique
时间窗: two years
Rate NIPS - Infant Pain Scale
次要结局
- Assess whether there is stress in children during the technical run(two years)
研究者
Maria Teresa de Mendonça Biasi
Assessment of pain and stress in children undergoing respiratory physiotherapy
Federal University of Uberlandia
研究点 (1)
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