Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
hydrotherapy
1 other identifier
interventional
8
1 country
1
Brief Summary
Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.
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 2005
Longer than P75 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, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedNovember 5, 2008
September 1, 2008
3.2 years
November 4, 2008
November 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001.
At two years
Study Arms (2)
Before Hidrotherapy
NO INTERVENTIONHidrotherapy
EXPERIMENTALInterventions
The Physiotherapy was performed with gentle movements in eight shape, from left to right, in addition to movements of unbundling girdle, light and slow the trunk and extremities posture and body by flexing the organization Wrapping the body.
Eligibility Criteria
You may qualify if:
- premature infants with gestational age less than 36 weeks,
- clinically stable, showing behavioral abnormalities such as intolerance to the touch, excessive crying, showing signs of pain in accordance with the scale
- difficulty of NFCS leave the stage of crying and agitation for a period of deep sleep during a period of not less than 60 minutes.
You may not qualify if:
- premature medically unstable because of the difficulty of monitoring in liquid medium, with a change in temperature on mechanical ventilation who had an infectious process due to the exacerbation of it in hot water, and syndromic children with congenital facial deformities that impede the use of scale NFCS for evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Luterana Do Brasil
Canoas, Rio Grande do Sul, 92425-900, Brazil
Related Publications (1)
Vignochi CM, Teixeira PP, Nader SS. Effect of aquatic physical therapy on pain and state of sleep and wakefulness among stable preterm newborns in neonatal intensive care units. Rev Bras Fisioter. 2010 May-Jun;14(3):214-20. English, Portuguese.
PMID: 20730365DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
July 1, 2005
Primary Completion
September 1, 2008
Study Completion
January 1, 2009
Last Updated
November 5, 2008
Record last verified: 2008-09