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临床试验/NCT03027206
NCT03027206已完成早期 1 期

Effects of Vibration Techniques and Expiratory Flow Acceleration in Premature Pain Parameters With Pneumonia

Amazon University0 个研究点目标入组 28 人开始时间: 2015年6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
28
主要终点
Evaluation of the parameters of the pain profile scale in preterm infants at different times

研究概览

简要总结

Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques were applied in an interval of up to ten minutes, for Three consecutive days. The pain indicators were evaluated according to the PIPP scale in three moments. For statistical analysis, the Friedman tests and Variance Analysis were applied, the level of significance adopted was 5%.

详细描述

A descriptive, longitudinal, quantitative approach was carried out in which 28 preterm infants with diagnosis of pneumonia hospitalized in the NICU and NICU of the Santa Casa de Misericórdia Foundation of Pará (FSCMPA) participated in the study period from July to October 2016. The research obeyed ethical principles Of Resolution 466/12 of the National Health Council (CNS) and was initiated after approval by the Research Ethics Committee of the FSCMPA, opinion 1,690,842. The selection criteria were obtained through the collection of data from the records of newborns and annotated in standardized charts. Once included in the study, the patients were randomly divided into two groups of 14 PTNB, the premature group 1 were submitted to the vibration technique (rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior chest region) and the Of Group 2 to the acceleration of the expiratory flow (soft compression of the thorax applied with one hand in the lower ribs and the other using the ulnar border on the supramammary line). Both techniques were performed with the premature dorsal position, at the time of the expiratory phase, with a maximum duration of 10 minutes, once a day, for three consecutive days, in the afternoon period and by the same physiotherapist. After this procedure, aspiration of the upper airways of premature infants was performed. The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its completion (T3), by a researcher previously trained and blind regarding the procedure performed. PIPP is a multidimensional instrument that evaluates pain indicators in the newborn using the following parameters: gestational age and alertness (contextual factors), heart rate and peripheral oxygen saturation (physiological indicators) that were measured by means of a pulse oximeter Of the brand (Dixtal®) and three aspects of facial mimetics (behavioral factors). Their scores may range from 0 to 21, scores less than or equal to 6 indicate absence of pain, scores above 6 represent mild pain and scores higher than 12 indicate the presence of moderate to severe pain.

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 (Participant)

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

  • Included in this study were RNPT of both genders, of low weight (1500 to 2500g) or normal weight (over 2500g).
  • With clinical diagnosis of pneumonia.
  • Who were on spontaneous ventilation (ambient air or with the aid of oxygen therapy).
  • Agreed to participate in the research, through the signing of the Informed Consent Form for minors.

排除标准

  • Newborns with a gestational age greater than 37 weeks.
  • With diseases or procedures that cause pain in the newborn such as necrotizing enterocolitis, thoracotraumatis, thoracic or abdominal drainage, and umbilical catheter.
  • Who were less than 72 hours Life with birth weight less than 1500g (very low weight and extreme low weight).
  • As well as those who underwent invasive or non-invasive mechanical ventilation.
  • With vasoactive drugs or medications that interfered in the physiological parameters of pain.

结局指标

主要结局

Evaluation of the parameters of the pain profile scale in preterm infants at different times

时间窗: The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.

The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its termination (T3), by a researcher previously trained and blind as to the procedure performed

次要结局

未报告次要终点

研究者

发起方
Amazon University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Eduardo Santos Avila

Assistant teacher

Amazon University

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