Respiratory Therapy and Newborn Pain: Comparison Between Techniques

Not Applicable

Completed

• Conditions: Newborn Pain; Respiratory Therapy Techniques
• Interventions: Procedure: Physical Therapy; Procedure: Thoracoabdominal rebalancing

• Registration Number: NCT01240044
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-10
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Therapy	Physical Therapy	In this group the newborns are submitted to the mechanical vibrator.
Thoracoabdominal rebalancing	Thoracoabdominal rebalancing	In this group the newborns receive the thoracoabdominal rebalancing.

Primary Outcome Measures

Name	Time	Method
Changes in cardiorespiratory parameters	Immediately after intervention and 15 minutes after the end of the intervention
Pain Scales (NIPS, PIPP, NFCS)	Immediately after intervention and 15 minutes after the end of the intervention

Trial Locations

Locations (1)

Maternidade Carmela Dutra Hospital; 🇧🇷 Florianópolis, Santa Catarina, Brazil