Viewing Study NCT05521620


Ignite Creation Date: 2025-12-25 @ 4:08 AM
Ignite Modification Date: 2026-02-12 @ 8:48 PM
Study NCT ID: NCT05521620
Status: COMPLETED
Last Update Posted: 2022-08-31
First Post: 2022-08-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: A Father-friendly Neonatal Intensive Care Unit
Sponsor: Kolding Sygehus
Organization:

Study Overview

Official Title: What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?
Status: COMPLETED
Status Verified Date: 2022-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: