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Respiratory Physiotherapy Change Premature Pain With Pneumonia (RPCPPWP)

Primary Purpose

Premature, Pneumonia, Pain

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Vibration technique
Acceleration of expiratory flow
Sponsored by
Amazon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Vibration technique

    Acceleration of expiratory flow

    Arm Description

    Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax

    Soft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 21, 2016
    Last Updated
    January 19, 2017
    Sponsor
    Amazon University
    Collaborators
    Fundação Santa Casa de Misericórdia do Pará (FSCMPA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03027206
    Brief Title
    Respiratory Physiotherapy Change Premature Pain With Pneumonia
    Acronym
    RPCPPWP
    Official Title
    Effects of Vibration Techniques and Expiratory Flow Acceleration in Premature Pain Parameters With Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Amazon University
    Collaborators
    Fundação Santa Casa de Misericórdia do Pará (FSCMPA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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%.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature, Pneumonia, Pain, Physiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vibration technique
    Arm Type
    Experimental
    Arm Description
    Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax
    Arm Title
    Acceleration of expiratory flow
    Arm Type
    Experimental
    Arm Description
    Soft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line
    Intervention Type
    Other
    Intervention Name(s)
    Vibration technique
    Intervention Description
    Comparison of different technique
    Intervention Type
    Other
    Intervention Name(s)
    Acceleration of expiratory flow
    Intervention Description
    Comparison of different technique
    Primary Outcome Measure Information:
    Title
    Evaluation of the parameters of the pain profile scale in preterm infants at different times
    Description
    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
    Time Frame
    The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25607427
    Citation
    Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sanchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015 Jan 22;372(4):331-40. doi: 10.1056/NEJMoa1403489.
    Results Reference
    result
    PubMed Identifier
    23582727
    Citation
    Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.
    Results Reference
    result
    PubMed Identifier
    26352946
    Citation
    Brandao AM, Domingues AP, Fonseca EM, Miranda TM, Belo A, Moura JP. [Premature labour with or without preterm premature rupture of membranes: maternal, obstetric and neonatal features]. Rev Bras Ginecol Obstet. 2015 Sep;37(9):428-33. doi: 10.1590/SO100-720320150005283. Portuguese.
    Results Reference
    result
    PubMed Identifier
    27420164
    Citation
    Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.
    Results Reference
    result
    PubMed Identifier
    15060237
    Citation
    Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
    Results Reference
    result
    PubMed Identifier
    19462133
    Citation
    Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.
    Results Reference
    result

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