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Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units (hydrotherapy)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Universidade Luterana do Brasil.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidade Luterana do Brasil
ClinicalTrials.gov Identifier:
NCT00785837
First received: November 4, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Perinatal Care
 Other: Aquatic Physical Therapy

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units

Further study details as provided by Universidade Luterana do Brasil:

Primary Outcome Measures:
  • 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. [ Time Frame: At two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: July 2005
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Before Hidrotherapy
Experimental: Hidrotherapy Other: Aquatic Physical Therapy
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.

Detailed Description:

This was a pilot study assessing the technique in this population. The study was conducted with 8 stable premature infants admitted in the Neonatal Intensive Care Unit (ICU) from Hospital Luterano de Porto Alegre. 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. The score in pain assessment scale was reduced from 5,38 ± 0.91 to 0.25 ± 0.46, p < 0.001 after intervention. The study suggests that aquatic physical therapy could be a simple and effective method to reduce pain and stress in premature infants admitted in the neonatal ICU.

  Eligibility

Ages Eligible for Study:   up to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785837

Locations
Brazil
Universidade Luterana Do Brasil Recruiting
Canoas, Rio Grande Do Sul, Brazil, 92425-900
Contact: CARINE M VIGNOCHI, PHD     51 84510533     carinemv@yahoo.com.br    
Principal Investigator: Carine M Vignochi, Phd            
Sponsors and Collaborators
Universidade Luterana do Brasil
  More Information

No publications provided by Universidade Luterana do Brasil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: CARINE MORAES VIGNOCHI, ULBRA - UNIVERSIDADE LUTERANA DO BRASIL
ClinicalTrials.gov Identifier: NCT00785837     History of Changes
Other Study ID Numbers: hydrotherapy
Study First Received: November 4, 2008
Last Updated: November 4, 2008
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee

Keywords provided by Universidade Luterana do Brasil:
Hydrotherapy
Perinatal Care
Neonatology

ClinicalTrials.gov processed this record on May 23, 2013