Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedMarch 14, 2016
March 1, 2016
2 months
March 3, 2016
March 8, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
4 months
Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
4 months
Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
4 months
Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
Unrecognized Condition
4 months
Secondary Outcomes (1)
Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
4 months
Study Arms (1)
Hydrokinesiotherapy in preterm
EXPERIMENTALSalivary cortisol samples, pain applying the Neonatal Infant Pain Scale Scale, heart rate, respiratory rate and oxygen saturation were collected before and after hydrokinesiotherapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- gestational age above 37 weeks
- clinically stable
- without ventilatory support
You may not qualify if:
- access deep below the shoulders
- umbilical catheterization
- neurological and cardiac disorders
- clinically unstable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Welcy Cassiano Tobinaga
Rio de Janeiro, Rio de Janeiro, Brazil
Related Publications (1)
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.
PMID: 27672453DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Welcy Cassiano Tobinaga, Student
University Hospital Pedro Ernesto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 14, 2016
Study Start
July 1, 2015
Primary Completion
September 1, 2015
Study Completion
November 1, 2015
Last Updated
March 14, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share