Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

March 8, 2016 updated by: Welcy Cassiano de Oliveira Tobinaga, Hospital Universitario Pedro Ernesto
This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Newborns have the neurological maturity to perceive pain, including preterm. In the environment of the neonatal intensive care unit newborns are subject to environmental stress and numerous painful interventions. Based on the physiological properties of water, it is known that the hydrotherapy promotes comfort, reduces stress, and as a resource for treatment of various diseases. This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit.

Study Type

Interventional

Enrollment (Actual)

15

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

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Welcy Cassiano Tobinaga

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

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gestational age above 37 weeks
  • clinically stable
  • without ventilatory support

Exclusion Criteria:

  • access deep below the shoulders
  • umbilical catheterization
  • neurological and cardiac disorders
  • clinically unstable

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrokinesiotherapy in preterm
Salivary cortisol samples, pain applying the Neonatal Infant Pain Scale Scale, heart rate, respiratory rate and oxygen saturation were collected before and after hydrokinesiotherapy
Procedure: Hydrokinesiotherapy
physical therapy technique used in a plastic bucket approved by ANVISA , with water temperature monitored at 37 ° C, water level up to the shoulders and by the physical properties of water, was allowed to mobilize the newborn facilitating the feeling of relaxation and standard suitable movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
Time Frame: 4 months
Unrecognized Condition
4 months
Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
Time Frame: 4 months
Unrecognized Condition
4 months
Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
Time Frame: 4 months
Unrecognized Condition
4 months
Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
Time Frame: 4 months
Unrecognized Condition
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
Time Frame: 4 months
Unrecognized Condition
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Pedro Ernesto

Investigators

  • Principal Investigator: Welcy Cassiano Tobinaga, Student, University Hospital Pedro Ernesto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUPedroernesto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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