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Completed

NCT Number: NCT05521620

A Father-friendly Neonatal Intensive Care Unit

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.

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Key information

Conditions

Stress Behavior Masculinity Perception, Self Self Efficacy Social Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatrics and Adolescent Medicine at the University Hospital of Southern Denmark, Kolding

Kolding, 6000, Denmark

About this study

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

  • A baseline measurement
  • Development and implementation of the intervention a father friendly NICU
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The father-friendly NICU

Behavioral
  • Fathers have skin-to-skin contact with their infants
  • Fathers participate in important situations
  • Fathers receive information and guidance directly
  • Both parents participate in meaningful conversations
  • The department organize mother and father groups
  • The families have the opportunity to have a close family member to support them
  • Older siblings have the opportunity to stay overnight.
  • The department offer counseling by a social worker

Primary outcomes

  1. Stress (The Parental Stressor Scale: Neonatal Intensive Care Unit)

    Time frame: 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)

    The primary outcome was the difference in the overall stress score, determined using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) score in both the control and intervention groups.

    Fathers were asked to rate their stress related to particular situations on a 5-point Likert scale, ranging from 1 (not at all stressful) to 5 (extremely stressful). Fathers who had not experienced a particular situation on an item indicated this with a "not relevant" response. The maximal score was 5, a high score indicating a high level of paternal stress.

  2. Parental Support (The Nurse Parent Support Tool)

    Time frame: 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)

    The primary outcome was the difference in fathers' perception of received staff support in the control group compared to the intervention group.

    The questionnaire included four dimensions of nurse support: 1) communication of information related to the infant's condition and care (nine items), 2) support mainly directed to enhance parental role (four items), 3) emotional support to help parents cope with their infant's sickness (three items), and 4) caregiving support concerning the quality of care provided to the infant (five items).

    For each item, the parents indicated the degree of support on a 5-point Likert scale ranging from 1 (never) to 5 (always) 19.

  3. Nurses self-efficacy (Self-efficacy (SE))

    Time frame: Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)

    The primary outcome was the difference between the nurses' SE scores for father and mother questions in the intervention group in comparison with the control group

    The nurses were asked to evaluate own ability to guide and support the parents in different situations (Self-efficacy score). The SE score was rated on a scale ranging from 1, indicating "Not at all sure," to 10, indicating "Definitely sure".

  4. Self-efficacy follow-up

    Time frame: After the implementation of the intervention (January 2015) to five years after (February 2021).

    The primary outcome was the difference between the nurses' SE score on father and mother questions from after the implementation of the intervention to five years after.

    The nurses were asked to evaluate own ability to guide and support the parents in different situations (Self-efficacy score). The SE score was rated on a scale ranging from 1, indicating "Not at all sure," to 10, indicating "Definitely sure".

Sponsors and collaborators

Lead sponsor

Kolding Sygehus

Other

Registry information

Official study title

What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?

Important dates

Study start
2011
Primary completion
2015
Study completion
2021
First posted
Aug 30, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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