Clinical trial NCT05521620: A Father-friendly Neonatal Intensive Care Unit
Official title: What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Self Efficacy
Perception, Self
Keywords: Father
Intensive Care Units, Neonatal
Parental support
Stress
Self-efficacy
Mothers
Nurse
Participatory reseach
Masculinity
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A before- and-after intervention study
Primary purpose: SUPPORTIVE_CARE

Brief summary: An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

Detailed description: An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

The study was conducted in 3 steps

1. A baseline measurement
2. Development and implementation of the intervention a father friendly NICU
3. After measurement

Different questionnaires were used:

* The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
* The Nurse Parent Support Tool (NPST)
* A questionnaire intended to measure nurses self-efficacy (SE).

The study was approved by the Danish Data Protection Agency (No 19/20297) and the procedures were in accordance with the Helsinki Declaration. In accordance with the Danish law, this study did not need to be reviewed by an ethics committee.

Eligibility criteria: Inclusion Criteria:

* fathers/mothers with infants admitted to the NICU were eligible
* nurses who work in Danish NICUs

Exclusion Criteria:

* fathers/mothers who did not understand verbal and written Danish
* fathers/mothers of critically ill newborn infants
* fathers of newborn infants whose mother was critically ill
* fathers/mothers of newborn infants admitted to the NICU from home.
* nurses without patient-contact, on maternity- or long-term sickness-leave

Primary outcomes:
measure: Stress (The Parental Stressor Scale: Neonatal Intensive Care Unit)
timeFrame: Measured on admission to the NICU (during the first 3 days of hospitalization), at the 14th day of hospitalization , and at the day of discharge from the NICU (up to 1/2 year)
measure: Parental Support (The Nurse Parent Support Tool)
timeFrame: Measured on admission to the NICU (during the first 3 days of hospitalization), and at the day of discharge from the NICU (up to 1/2 year)
measure: Nurses self-efficacy (Self-efficacy (SE))
timeFrame: Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)
measure: Self-efficacy follow-up
timeFrame: After the implementation of the intervention (January 2015) to five years after (February 2021).
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine at the University Hospital of Southern Denmark, Kolding
Study officials:
affiliation: Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital,Kolding
name: Betty Noergaard, Ph.d
role: PRINCIPAL_INVESTIGATOR
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