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

NCT ID: NCT00785837

Last Updated: 2008-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Perinatal Care

Keywords

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Hydrotherapy Perinatal Care Neonatology

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Before Hidrotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Hidrotherapy

Group Type EXPERIMENTAL

Aquatic Physical Therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Luterana do Brasil

OTHER

Sponsor Role lead

Responsible Party

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ULBRA - UNIVERSIDADE LUTERANA DO BRASIL

Locations

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Universidade Luterana Do Brasil

Canoas, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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CARINE M VIGNOCHI, PHD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 20730365 (View on PubMed)

Other Identifiers

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hydrotherapy

Identifier Type: -

Identifier Source: org_study_id