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Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

Primary Purpose

Newborn Preterm

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydrokinesiotherapy
Sponsored by
Hospital Universitario Pedro Ernesto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Newborn Preterm

Eligibility Criteria

undefined - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Welcy Cassiano Tobinaga

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrokinesiotherapy in preterm

Arm Description

Salivary cortisol samples, pain applying the Neonatal Infant Pain Scale Scale, heart rate, respiratory rate and oxygen saturation were collected before and after hydrokinesiotherapy

Outcomes

Primary Outcome Measures

Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition

Secondary Outcome Measures

Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition

Full Information

First Posted
March 3, 2016
Last Updated
March 8, 2016
Sponsor
Hospital Universitario Pedro Ernesto
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1. Study Identification

Unique Protocol Identification Number
NCT02707731
Brief Title
Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
Official Title
Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Pedro Ernesto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Preterm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrokinesiotherapy in preterm
Arm Type
Experimental
Arm Description
Salivary cortisol samples, pain applying the Neonatal Infant Pain Scale Scale, heart rate, respiratory rate and oxygen saturation were collected before and after hydrokinesiotherapy
Intervention Type
Procedure
Intervention Name(s)
Hydrokinesiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
Description
Unrecognized Condition
Time Frame
4 months
Title
Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
Description
Unrecognized Condition
Time Frame
4 months
Title
Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
Description
Unrecognized Condition
Time Frame
4 months
Title
Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
Description
Unrecognized Condition
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
Description
Unrecognized Condition
Time Frame
4 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Welcy Cassiano Tobinaga, Student
Organizational Affiliation
University Hospital Pedro Ernesto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Welcy Cassiano Tobinaga
City
Rio de Janeiro
State/Province
RJ
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27672453
Citation
de Oliveira Tobinaga WC, de Lima Marinho C, Abelenda VL, de Sa PM, Lopes AJ. Short-Term Effects of Hydrokinesiotherapy in Hospitalized Preterm Newborns. Rehabil Res Pract. 2016;2016:9285056. doi: 10.1155/2016/9285056. Epub 2016 Sep 8.
Results Reference
derived

Learn more about this trial

Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

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