Respiratory Therapy and Newborn Pain: Comparison Between Techniques

NCT01240044 | Completed DMC

• 1 other identifier: PTNB 2010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn Pain; Respiratory Therapy Techniques

Keywords

Newborn Pain; Respiratory Physiotherapy; Neonatal intensive care unit

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Control Group

NO INTERVENTION

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

Physical Therapy

EXPERIMENTAL

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

Procedure: Physical Therapy

Thoracoabdominal rebalancing

EXPERIMENTAL

In this group the newborns receive the thoracoabdominal rebalancing.

Procedure: Thoracoabdominal rebalancing

Interventions

Thoracoabdominal rebalancing PROCEDURE

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.

Thoracoabdominal rebalancing

Physical Therapy PROCEDURE

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.

Physical Therapy

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Maternidade Carmela Dutra Hospital

Florianópolis, Santa Catarina, 88015-270, Brazil

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 15, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 19, 2013

Record last verified: 2010-10

Locations

BR (1)