Condition category
Mental and Behavioural Disorders
Date applied
21/06/2010
Date assigned
13/07/2010
Last edited
07/09/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.neonatal.rh.dk

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

Publication citations

Additional files

Editorial Notes