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
Protocol serial number	N/A
Sponsor	Copenhagen University Hospital (Denmark)
Funder	Copenhagen University Hospital (Denmark) - Department of Neonatology

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

Primary study design	Interventional
Study design	Single centre interventional controlled study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study acronym	GFC
Study objectives	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(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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key 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
Key exclusion criteria	Parents of babies where the survival of the child is most doubtful
Date of first enrolment	01/10/2010
Date of final enrolment	31/10/2012

Locations

Countries of recruitment

Denmark

Study participating centre

Department of Neonatology, 5024

Copenhagen
DK-2100
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes