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

November 4, 2008
November 4, 2008
July 2005
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units

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.

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.

Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Perinatal Care
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.
  • No Intervention: Before Hidrotherapy
  • Experimental: Hidrotherapy
    Intervention: Other: Aquatic Physical Therapy
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 Jun;14(3):214-20. English, Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
January 2009
September 2008   (final data collection date for primary outcome measure)

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.
Both
up to 36 Weeks
No
Not Provided
Brazil
 
NCT00785837
hydrotherapy
Yes
CARINE MORAES VIGNOCHI, ULBRA - UNIVERSIDADE LUTERANA DO BRASIL
Universidade Luterana do Brasil
Not Provided
Not Provided
Universidade Luterana do Brasil
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP