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Clinical Trials/NCT01240044
NCT01240044
Completed
Not Applicable

Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques

University of the State of Santa Catarina1 site in 1 country60 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Newborn Pain
Sponsor
University of the State of Santa Catarina
Enrollment
60
Locations
1
Primary Endpoint
Changes in cardiorespiratory parameters
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
December 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of the State of Santa Catarina
Responsible Party
Principal Investigator
Principal Investigator

Camila Isabel Santos Schivinski

Dr.

University of the State of Santa Catarina

Eligibility 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.

Outcomes

Primary Outcomes

Changes in cardiorespiratory parameters

Time Frame: Immediately after intervention and 15 minutes after the end of the intervention

Pain Scales (NIPS, PIPP, NFCS)

Time Frame: Immediately after intervention and 15 minutes after the end of the intervention

Study Sites (1)

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