Respiratory Therapy and Newborn Pain: Comparison Between Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Camila Isabel Santos Schivinski, University of the State of Santa Catarina
ClinicalTrials.gov Identifier:
NCT01240044
First received: November 12, 2010
Last updated: June 18, 2013
Last verified: October 2010
  Purpose

This study intend to assess the pain intensity of newborns in neonatal intensive care unit (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The babies were categorized according to gestational age , age, weight, diagnosis, support and signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal rebalancing. Each newborn received just one physical therapy session in that they were assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The hypothesis is that newborns hospitalized in intensive care unit did not show pain when undergoing respiratory therapy.


Condition Intervention
Newborn Pain
Respiratory Therapy Techniques
Procedure: Thoracoabdominal rebalancing
Procedure: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques

Further study details as provided by University of the State of Santa Catarina:

Primary Outcome Measures:
  • Changes in cardiorespiratory parameters [ Time Frame: Immediately after intervention and 15 minutes after the end of the intervention ] [ Designated as safety issue: No ]
  • Pain Scales (NIPS, PIPP, NFCS) [ Time Frame: Immediately after intervention and 15 minutes after the end of the intervention ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
In this group the newborns remained at rest 20 minutes and receive no intervention of respiratory therapy.
Experimental: Physical Therapy
In this group the newborns are submitted to the mechanical vibrator.
Procedure: Physical Therapy
In this group the newborns were first submitted to the mechanical vibrator applied over a diaper, on the chest of newborns for 5 min, as follows: 1min 1min right hemithorax and the left hemithorax, both previously, followed 30 seconds in the lateral aspect of each hemithorax; more than 1min in each hemithorax in the posterior region. The mechanical vibrator was performed subsequent to manual chest compression, using light hand pressure on the chest of newborns, respecting the compliance of the chest. The chest compression was applied for 2min 2min in the right hemithorax and left-sided chest, above, and 1 minute on each side, another 2 minutes on the back of each hemithorax, totaling 10 minutes of compression. Next to chest compression, mechanical vibration was applied for 5 min in the same topographical sequence described.
Experimental: Thoracoabdominal rebalancing
In this group the newborns receive the thoracoabdominal rebalancing.
Procedure: Thoracoabdominal rebalancing
In this group the infants received four handlings thoracoabdominal rebalancing, in order: 1) 5min support thoracoabdominal, in which the therapist leaned one hand on the lower chest and upper abdomen of the newborn, with some of its fingers on the ribs, pulling them gently down and keeping them in that position during inspiration, 2) more than 5 minutes of abdominal support, carried by hand in the lower abdomen of the newborn, applying light pressure during inspiration enough to be beaten by the diaphragm of the newborn and not to increase the use of accessory muscles of inspiration, 3) 5min support ileo-costal, by a slight manual pressure of the physiotherapist on the lateral chest and abdomen of the newborn, maintained throughout inspiration and 4) finally ran up 5min ginga thoracic maneuver slight manual pressure on the lower chest of newborns, directing the costal movement during expiration, now an then the other hemithorax.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy.

Exclusion Criteria:

  • Newborns with contraindication of respiratory therapy, those that had problems during any of the study procedures and changes in those suffering from respiratory support or oxygen therapy during data collection.
  • If there was failure to collect any of the parameters for evaluating the newborn also was no longer part of the sample.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01240044

Locations
Brazil
Maternidade Carmela Dutra Hospital
Florianópolis, Santa Catarina, Brazil, 88015-270
Sponsors and Collaborators
University of the State of Santa Catarina
  More Information

No publications provided

Responsible Party: Camila Isabel Santos Schivinski, Dr., University of the State of Santa Catarina
ClinicalTrials.gov Identifier: NCT01240044     History of Changes
Other Study ID Numbers: PTNB 2010
Study First Received: November 12, 2010
Last Updated: June 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of the State of Santa Catarina:
Newborn Pain
Respiratory Physiotherapy
Neonatal intensive care unit

ClinicalTrials.gov processed this record on July 28, 2014