- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240044
Respiratory Therapy and Newborn Pain: Comparison Between Techniques
June 18, 2013 updated by: Camila Isabel Santos Schivinski, University of the State of Santa Catarina
Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santa Catarina
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Florianópolis, Santa Catarina, Brazil, 88015-270
- Maternidade Carmela Dutra Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 4 weeks (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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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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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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Scales (NIPS, PIPP, NFCS)
Time Frame: Immediately after intervention and 15 minutes after the end of the intervention
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Immediately after intervention and 15 minutes after the end of the intervention
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Changes in cardiorespiratory parameters
Time Frame: Immediately after intervention and 15 minutes after the end of the intervention
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Immediately after intervention and 15 minutes after the end of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 12, 2010
First Submitted That Met QC Criteria
November 12, 2010
First Posted (Estimate)
November 15, 2010
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 18, 2013
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- PTNB 2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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