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ISRCTN
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ISRCTN82244704
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ClinicalTrials.gov identifier
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Public title
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Guided Family-Centred Care - relieving parental stress related to preterm birth and hospital admission through guided communication between parents and health care professionals
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Scientific title
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A randomised controlled intervention study of patient-centred communication with neonatal nurses in parents of preterm children and their levels of parental stress
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Acronym
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GFC
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Serial number at source
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N/A
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Study hypothesis
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Parental stress is reduced when communication with healthcare professionals is focused on individualised support. Using the method Guided Family-Centred Care communication will be based on the perspectives of the individual family-members resulting in individualised support. By relieving parental stress during hospital admission the transition to home is made easier as the parents confidence in parental skills are increased and managing the parental role in everyday life with the baby is strengthened.
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Lay summary
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Not provided at time of registration
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Ethics approval
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According to the Ethics Board of The Capital Region of Denmark there is no obligation to obtain approval of this kind of project.
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Study design
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Single centre interventional controlled study
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Parental stress
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Participants - inclusion criteria
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1. Both parents (if possible) of premature babies born before 34 weeks of gestation admitted to the neonatal intensive care unit, Copenhagen University Hospital
2. Inclusion within the first 24 hours of hospital admission (when the condition of the baby is very critical inclusion can be postponed)
3. Must be able to speak, read and write in Danish
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Participants - exclusion criteria
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Parents of babies where the survival of the child is most doubtful
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Anticipated start date
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01/10/2010
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Anticipated end date
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31/10/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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150 families (75 in each group)
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Interventions
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Intervention group:
Guided Family-Centred Care based on frequent conversations between the parents and healthcare professionals. Parents use semi-structured reflection sheets for some conversations.
Reflection sheets:
Three sheets have been developed:
1. Admission conversation - used when preparing for a conversation held in the initial critical phase. Consists of questions focused on parents experiences and needs - emotional as well as practical.
2. Follow-up conversation – used when preparing for a conversation held in a more steady phase: Consists of unfinished sentences focused at values clarification.
3. Discharge conversation: Consists of questions focused on identification of the parents' worries and delights of going home. Weekly follow-up conversations without using reflection sheets are held throughout hospital stay. Conversations are registered in a Case Report Form.
Control group:
No special actions - must not at any time use reflection sheets.
The total duration of the intervention is the total admission period which normally lasts until the expected date of birth - corresponding to 6 - 17 weeks or longer.
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Primary outcome measure(s)
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Difference between the groups in reduction of stress level during admission. The Parental Stress Scale:NICU (PSS:NICU) will be administered at admission and at discharge. PSS:NICU is developed to measure parents experiences of stressors from the physical and the psycho-social environment in the NICU. Stress is measured on a 5-point Likert Scale rating from 1 = Not at all stressful to 5 = Extremely stressful. Measured within the first 72 hours of admission and within the last 24 hours of admission.
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Secondary outcome measure(s)
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1. Differences in parental stress score within the three subscales of the PSS:NICU
2. Difference in parents scoring experiences of collaboration with neonatal nurses using the Nurse Parent Support Tool (NPST). NPST measures parents experiences of support and collaboration using a 5-point Likert scale rating from 1 = Almost never to 5 = Almost always.
Measured within the last 24 hours of admission.
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Sources of funding
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Copenhagen University Hospital (Denmark) - Department of Neonatology
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Trial website
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Publications
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Contact name
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Mrs
Janne
Weis
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Address
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Department of Neonatology, 5024
Blegdamsvej 9
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City/town
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Copenhagen
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Zip/Postcode
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DK-2100
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Country
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Denmark
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Tel
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+45 35458614
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Fax
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+45 35455025
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Email
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janne.weis@rh.regionh.dk
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Sponsor
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Copenhagen University Hospital (Denmark)
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Address
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Department of Neonatology, 5023
Blegdamsvej 9
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City/town
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Copenhagen
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Zip/Postcode
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DK-2100
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Country
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Denmark
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Tel
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+45 35455023
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Fax
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+45 35455025
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Email
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neonatal@rh.regionh.dk
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Sponsor website:
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http://www.neonatal.rh.dk
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Date applied
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21/06/2010
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Last edited
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07/09/2011
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Date ISRCTN assigned
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13/07/2010
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