Respiratory Therapy and Newborn Pain: Comparison Between Techniques

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. Identifier: NCT01240044
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
Camila Isabel Santos Schivinski, University of the State of Santa Catarina

Brief Summary:
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 or disease Intervention/treatment Phase
Newborn Pain Respiratory Therapy Techniques Procedure: Thoracoabdominal rebalancing Procedure: Physical Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Changes in cardiorespiratory parameters [ Time Frame: Immediately after intervention and 15 minutes after the end of the intervention ]
  2. Pain Scales (NIPS, PIPP, NFCS) [ Time Frame: Immediately after intervention and 15 minutes after the end of the intervention ]

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01240044

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

Responsible Party: Camila Isabel Santos Schivinski, Dr., University of the State of Santa Catarina Identifier: NCT01240044     History of Changes
Other Study ID Numbers: PTNB 2010
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: October 2010

Keywords provided by Camila Isabel Santos Schivinski, University of the State of Santa Catarina:
Newborn Pain
Respiratory Physiotherapy
Neonatal intensive care unit