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

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.

Study Overview

• Status: Unknown
• Conditions: Perinatal Care
• Intervention / Treatment: Other: Aquatic Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Canoas, Rio Grande Do Sul, Brazil, 92425-900
      • Recruiting
      • Universidade Luterana Do Brasil
      • Contact: CARINE M VIGNOCHI, PHD; Phone Number: 51 84510533; Email: carinemv@yahoo.com.br
      • Principal Investigator: Carine M Vignochi, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade Luterana do Brasil

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Anticipated): September 1, 2008
• Study Completion (Anticipated): January 1, 2009

Study Registration Dates

• First Submitted: November 4, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Estimate): November 5, 2008
• Last Update Submitted That Met QC Criteria: November 4, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Neonatology; Hydrotherapy; Perinatal Care
• Other Study ID Numbers: hydrotherapy