Perinatal CarehydrotherapyNCT00785837
Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
A study testing Aquatic Physical Therapy in people with Perinatal Care, run by Universidade Luterana do Brasil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Perinatal Care
- What is being tested?
- Aquatic Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2005to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Luterana Do Brasil
Canoas, Rio Grande do Sul, 92425-900
CARINE M VIGNOCHI, PHD, 51 84510533, carinemv@yahoo.com.br
Carine M Vignochi, Phd
About this study
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.
Read the 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.
- Conditions
- Perinatal Care
- Being tested
- Aquatic Physical Therapy
- Keywords
- Hydrotherapy, Perinatal Care, Neonatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Before Hidrotherapy | No intervention | Not described |
| Hidrotherapy | Experimental | Not described Receives: Other: Aquatic Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJul 2005
- Primary completionSep 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Luterana do Brasil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785837
- Sponsor's protocol ID
- hydrotherapy
- Acronym
- hydrotherapy
- Status last verified
- Sep 2008
- First submitted
- 4 Nov 2008
- Last updated
- 5 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20730365
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
- ClinicalTrials.gov ID
- NCT00785837
- Acronym / sponsor ID
- hydrotherapy / hydrotherapy
- Conditions
- Perinatal Care
- Keywords
- Hydrotherapy, Perinatal Care, Neonatology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Universidade Luterana do BrasilUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Hidrotherapy | No intervention | – |
| Hidrotherapy | Experimental | Other: Aquatic Physical Therapy |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic Physical TherapyThe 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. | Other | Hidrotherapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2008.
- Derived from this study: PubMed 20730365Vignochi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Physical Therapy in people with Perinatal Care, run by Universidade Luterana do Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00785837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2008.