Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-9yz2pb |
Date of registration:
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29/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Educative practice and maternal stress of premature infant: randomized clinical trial
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Scientific title:
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Effects of prematurity: mother stress and metabolic programming after hospital discharge /Stress and maternal role after an educational intervention - : Prematurity, maternal stress and metabolic programming |
Date of first enrolment:
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01/01/2015 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-9yz2pb |
Study type:
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Intervention |
Study design:
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Randomized clinical trial, paralel, one blind, 2 arms, prospective
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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CLAUDIA SILVEIRA
VIERA |
Address:
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RUA BETULA
85807240
CASCAVEL
Brazil |
Telephone:
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+55(45)99120066 |
Email:
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clausviera@gmail.com |
Affiliation:
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universidade estadual do oeste do parana - unioeste |
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Name:
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CLAUDIA SILVEIRA
VIERA |
Address:
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RUA BETULA
85807240
CASCAVEL
Brazil |
Telephone:
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+55(45)99120066 |
Email:
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clausviera@gmail.com |
Affiliation:
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universidade estadual do oeste do parana - unioeste |
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Key inclusion & exclusion criteria
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Inclusion criteria: Preterm under 37 weeks of gestational age; preterm without malformation; teenager mother following with law responsable; literacy mother.
Exclusion criteria: Preterm has left for adoption; mothers who have related psychiatric problems; mothers who autorelate that are in continuous use of controlled drugs (anxiety or depression); mothers with medical complications or who have gone to death during the study; illiterate mothers; teenagers mothers without law companion; mothers who did not attend the consultations on the follow-up clinic between the 3rd and 6th month after discharge from the Neonatal Intensive Care Unit.
Age minimum:
14Y
Age maximum:
50Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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F01.829.263.370.290.170
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F01.145.126.990
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M01.060.703.520.520
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Prematurity and mother stress
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Intervention(s)
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Other
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15 mothers of premature newborns hospitalized in the Neonatal Intensive Care Unit in the university hospital selected by randomization will be part of the intervention group of the study and receive educational activities with themes about preterm care. The activities will be conducted as follow: The educational activity will be divided in two consecutive days, lasting one hour and thirty minutes each. The activities will be conducted by a nurse and a graduate student in Nursing and implemented in accordance with the following steps: 1) Literature review to identify issues related to the care of preterm infants in the hospital and at home that are frequently reported by mothers as doubts. The themes that emerged were: nursing, care breasts, milking and milk storage, complications signs (fever, crying, convulsions, changes in respiratory rate, etc.) and care with medication, baby hygiene, diapering and care of the preterm clothes; 2) Development of educational material to support the theoretical and practical lessons from the material obtained in the literature review; 3) Environmental Simulation of the Neonatal intensive care unit in the Skills Laboratory of the hospital study, using material resources as radiant warmers, incubators, ventilator, heart monitors, probes, catheters, dolls, models and images; 4) Selection of participaes: three or four mothers among all hospitalized preterm will be selected to participate in the activity. After this selection during the mother's visit to preterm infants in the unit, the researchers will invited the mother to participate in the proposal, explained about research. and with acceptance, they signed the Informed Consent and Informed and the days of activities will be scheduled. 5) Reception of mothers in the Neona
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Primary Outcome(s)
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Reduction of maternal stress level between the 3rd and 6th month after discharge from the Neonatal Intensive Care Unit measured by the Parental Stress scales (measured in hospitalization), in which mothers must submit scores between 3 and 4 levels, that is considered moderate and high level of stress. After discharge the mother stress will be measured by the Parental Stress Index scale, during the preterm apointment in the follow up clinic, this scale is expected to the mothers will have lower scores than the 90th percentile, which indicates a lower level of stress.
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Secondary Outcome(s)
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Increase the mother's knowledge about caring for preterm infants that will be measured by the validated questionnaire of maternal knowledge analysis, pre and post-test. This questionnaire is expected to mothers, in the intervention, group show higher scores in the post-test than the mothers in the control group
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico -CNPq
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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