Respiratory Physiotherapy Change Premature Pain With Pneumonia

NCT ID: NCT03027206

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Premature Pneumonia Pain Physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vibration technique

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

Group Type EXPERIMENTAL

Vibration technique

Intervention Type OTHER

Comparison of different technique

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

Group Type EXPERIMENTAL

Acceleration of expiratory flow

Intervention Type OTHER

Comparison of different technique

Interventions

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Vibration technique

Comparison of different technique

Intervention Type OTHER

Acceleration of expiratory flow

Comparison of different technique

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação Santa Casa de Misericórdia do Pará (FSCMPA)

UNKNOWN

Sponsor Role collaborator

Amazon University

OTHER

Sponsor Role lead

Responsible Party

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Paulo Eduardo Santos Avila

Assistant teacher

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 25607427 (View on PubMed)

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.

Reference Type RESULT
PMID: 23582727 (View on PubMed)

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.

Reference Type RESULT
PMID: 26352946 (View on PubMed)

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.

Reference Type RESULT
PMID: 27420164 (View on PubMed)

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.

Reference Type RESULT
PMID: 15060237 (View on PubMed)

Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.

Reference Type RESULT
PMID: 19462133 (View on PubMed)

Other Identifiers

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1.690.842

Identifier Type: -

Identifier Source: org_study_id

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