Guided Family-Centred Care - relieving parental stress related to preterm birth and hospital admission through guided communication between parents and health care professionals

ISRCTN ISRCTN82244704
DOI https://doi.org/10.1186/ISRCTN82244704
Secondary identifying numbers N/A
Submission date
21/06/2010
Registration date
13/07/2010
Last edited
07/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Janne Weis
Scientific

Department of Neonatology, 5024
Blegdamsvej 9
Copenhagen
DK-2100
Denmark

Phone +45 35458614
Email janne.weis@rh.regionh.dk

Study information

Study designSingle centre interventional controlled study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled intervention study of patient-centred communication with neonatal nurses in parents of preterm children and their levels of parental stress
Study acronymGFC
Study objectivesParental 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(s)According to the Ethics Board of The Capital Region of Denmark there is no obligation to obtain approval of this kind of project.
Health condition(s) or problem(s) studiedParental stress
InterventionIntervention 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 typeOther
Primary outcome measureDifference 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 measures1. 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 study start date01/10/2010
Completion date31/10/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150 families (75 in each group)
Key inclusion criteria1. 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
Key exclusion criteriaParents of babies where the survival of the child is most doubtful
Date of first enrolment01/10/2010
Date of final enrolment31/10/2012

Locations

Countries of recruitment

  • Denmark

Study participating centre

Department of Neonatology, 5024
Copenhagen
DK-2100
Denmark

Sponsor information

Copenhagen University Hospital (Denmark)
Hospital/treatment centre

Department of Neonatology, 5023
Blegdamsvej 9
Copenhagen
DK-2100
Denmark

Phone +45 35455023
Email neonatal@rh.regionh.dk
Website http://www.neonatal.rh.dk
ROR logo "ROR" https://ror.org/05bpbnx46

Funders

Funder type

Hospital/treatment centre

Copenhagen University Hospital (Denmark) - Department of Neonatology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan