Respiratory Therapy and Newborn Pain: Comparison Between Techniques
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of the State of Santa Catarina.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of the State of Santa Catarina
Information provided by:
University of the State of Santa Catarina
ClinicalTrials.gov Identifier:
NCT01240044
First received: November 12, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
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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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated 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.
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Experimental: Physical Therapy
In this group the newborns are submitted to the mechanical vibrator.
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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.
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Experimental: Thoracoabdominal rebalancing
In this group the newborns receive the thoracoabdominal rebalancing.
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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.
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240044
Locations
| Brazil | |
| Maternidade Carmela Dutra Hospital | Recruiting |
| Florianópolis, Santa Catarina, Brazil, 88015-270 | |
| Contact: Maternidade Carmela Dutra +55 (48) 3251-7500 | |
| Principal Investigator: Camila Isabel S Schivinski | |
Sponsors and Collaborators
University of the State of Santa Catarina
More Information
No publications provided
| Responsible Party: | Camila Isabel S. Schivinski, Professor of Universidade do Estado de Santa Catarina |
| ClinicalTrials.gov Identifier: | NCT01240044 History of Changes |
| Other Study ID Numbers: | PTNB 2010 |
| Study First Received: | November 12, 2010 |
| Last Updated: | November 12, 2010 |
| 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 May 16, 2013