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Respiratory Physiotherapy Change Premature Pain With Pneumonia (RPCPPWP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03027206
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Fundação Santa Casa de Misericórdia do Pará (FSCMPA)
Information provided by (Responsible Party):
Paulo Eduardo Santos Avila, Amazon University

Brief Summary:
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%.

Condition or disease Intervention/treatment Phase
Premature Pneumonia Pain Physiotherapy Other: Vibration technique Other: Acceleration of expiratory flow Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Vibration Techniques and Expiratory Flow Acceleration in Premature Pain Parameters With Pneumonia
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Vibration technique
Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax
Other: Vibration technique
Comparison of different technique

Experimental: Acceleration of expiratory flow
Soft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line
Other: Acceleration of expiratory flow
Comparison of different technique




Primary Outcome Measures :
  1. Evaluation of the parameters of the pain profile scale in preterm infants at different times [ Time Frame: 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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Sedated.
  • With vasoactive drugs or medications that interfered in the physiological parameters of pain.
Publications of Results:

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Responsible Party: Paulo Eduardo Santos Avila, Assistant teacher, Amazon University
ClinicalTrials.gov Identifier: NCT03027206    
Other Study ID Numbers: 1.690.842
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pneumonia
Premature Birth
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications