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
About this trial
This is an interventional treatment trial for Premature
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.
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
NCT ID
NCT03027206
First Posted
November 21, 2016
Last Updated
January 19, 2017
Sponsor
Amazon University
Collaborators
Fundação Santa Casa de Misericórdia do Pará (FSCMPA)
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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Respiratory Physiotherapy Change Premature Pain With Pneumonia
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