Respiratory Therapy and Newborn Pain: Comparison Between Techniques

University of the State of Santa Catarina

Status: Completed

Conditions: Respiratory Therapy Techniques; Newborn Pain

Treatments: Procedure: Thoracoabdominal rebalancing; Procedure: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01240044

PTNB 2010

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control Group

No Intervention group

Description:

In this group the newborns remained at rest 20 minutes and receive no intervention of respiratory therapy.

Physical Therapy

Experimental group

Description:

In this group the newborns are submitted to the mechanical vibrator.

Treatment:

Procedure: Physical Therapy

Thoracoabdominal rebalancing

Experimental group

Description:

In this group the newborns receive the thoracoabdominal rebalancing.

Treatment:

Procedure: Thoracoabdominal rebalancing