Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

Newborn Preterm Clinical Trial

Official title:

Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707731
• Other study ID #: HUPedroernesto
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: March 8, 2016
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Weeks

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Newborn Preterm
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Brazil	Welcy Cassiano Tobinaga	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized	Unrecognized Condition	4 months	Yes
Primary	Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized	Unrecognized Condition	4 months	Yes
Primary	Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized	Unrecognized Condition	4 months	Yes
Primary	Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized	Unrecognized Condition	4 months	Yes
Secondary	Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized	Unrecognized Condition	4 months	Yes