Study of Respiratory Therapy and Newborn Pain That Made a Comparison Between Physiotherapeutical Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Changes in cardiorespiratory parameters
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- 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.
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Camila Isabel Santos Schivinski
Dr.
University of the State of Santa Catarina