Contact information
Type
Scientific
Primary contact
Mrs Janne Weis
ORCID ID
Contact details
Department of Neonatology
5024
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
+45 35458614
janne.weis@rh.regionh.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled intervention study of patient-centred communication with neonatal nurses in parents of preterm children and their levels of parental stress
Acronym
GFC
Study hypothesis
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.
Ethics approval
According to the Ethics Board of The Capital Region of Denmark there is no obligation to obtain approval of this kind of project.
Study design
Single centre interventional controlled study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Parental stress
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/10/2010
Overall trial end date
31/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150 families (75 in each group)
Participant exclusion criteria
Parents of babies where the survival of the child is most doubtful
Recruitment start date
01/10/2010
Recruitment end date
31/10/2012
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Neonatology, 5024
Copenhagen
DK-2100
Denmark
Sponsor information
Organisation
Copenhagen University Hospital (Denmark)
Sponsor details
Department of Neonatology
5023
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
+45 35455023
neonatal@rh.regionh.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Copenhagen University Hospital (Denmark) - Department of Neonatology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary