A Father-friendly Neonatal Intensive Care Unit

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521620
• Other study ID #: 19/20297
• Status: Completed
• Phase: N/A
• Start date: December 1, 2011
• Est. completion date: February 11, 2021

Study information

• Verified date: August 2022
• Source: Kolding Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 11, 2021
• Est. primary completion date: January 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Perception, Self
• Self Efficacy
• Stress

Intervention

Behavioral:
• The father-friendly NICU
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

Locations

Country	Name	City	State
Denmark	Department of Paediatrics and Adolescent Medicine at the University Hospital of Southern Denmark, Kolding	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Kolding Sygehus

Country where clinical trial is conducted

Denmark, 

References & Publications (23)

Ammentorp J, Kofoed PE. Coach training can improve the self-efficacy of neonatal nurses. A pilot study. Patient Educ Couns. 2010 May;79(2):258-61. doi: 10.1016/j.pec.2009.08.015. Epub 2009 Sep 27. — View Citation

Arockiasamy V, Holsti L, Albersheim S. Fathers' experiences in the neonatal intensive care unit: a search for control. Pediatrics. 2008 Feb;121(2):e215-22. doi: 10.1542/peds.2007-1005. Epub 2008 Jan 8. — View Citation

Bogdan R, Brown MA, Foster SB. Be honest but not cruel: staff/parent communication on a neonatal unit. Hum Organ. 1982 Spring;41(1):6-16. — View Citation

Fegran L, Helseth S, Fagermoen MS. A comparison of mothers' and fathers' experiences of the attachment process in a neonatal intensive care unit. J Clin Nurs. 2008 Mar;17(6):810-6. doi: 10.1111/j.1365-2702.2007.02125.x. — View Citation

Franck LS, Spencer C. Parent visiting and participation in infant caregiving activities in a neonatal unit. Birth. 2003 Mar;30(1):31-5. — View Citation

Johnson AN. Engaging fathers in the NICU: taking down the barriers to the baby. J Perinat Neonatal Nurs. 2008 Oct-Dec;22(4):302-6. doi: 10.1097/01.JPN.0000341361.37822.34. Review. — View Citation

Kaaresen PI, Rønning JA, Ulvund SE, Dahl LB. A randomized, controlled trial of the effectiveness of an early-intervention program in reducing parenting stress after preterm birth. Pediatrics. 2006 Jul;118(1):e9-19. — View Citation

Levy-Shiff R, Hoffman MA, Mogilner S, Levinger S, Mogilner MB. Fathers' hospital visits to their preterm infants as a predictor of father-infant relationship and infant development. Pediatrics. 1990 Aug;86(2):289-93. — View Citation

Lindberg B, Axelsson K, Ohrling K. Adjusting to being a father to an infant born prematurely: experiences from Swedish fathers. Scand J Caring Sci. 2008 Mar;22(1):79-85. doi: 10.1111/j.1471-6712.2007.00563.x. — View Citation

Lundqvist P, Jakobsson L. Swedish men's experiences of becoming fathers to their preterm infants. Neonatal Netw. 2003 Nov-Dec;22(6):25-31. — View Citation

Lundqvist P, Westas LH, Hallström I. From distance toward proximity: fathers lived experience of caring for their preterm infants. J Pediatr Nurs. 2007 Dec;22(6):490-7. — View Citation

Mackley AB, Locke RG, Spear ML, Joseph R. Forgotten parent: NICU paternal emotional response. Adv Neonatal Care. 2010 Aug;10(4):200-3. doi: 10.1097/ANC.0b013e3181e946f0. — View Citation

Meberg A, Wataker H. [Family-focused neonatal care]. Tidsskr Nor Laegeforen. 2010 Sep 9;130(17):1730-1. doi: 10.4045/tidsskr.10.0293. Norwegian. — View Citation

Miles MS, Holditch-Davis D. Parenting the prematurely born child: pathways of influence. Semin Perinatol. 1997 Jun;21(3):254-66. Review. — View Citation

Noergaard B, Ammentorp J, Fenger-Gron J, Kofoed PE, Johannessen H, Thibeau S. Fathers' Needs and Masculinity Dilemmas in a Neonatal Intensive Care Unit in Denmark. Adv Neonatal Care. 2017 Aug;17(4):E13-E22. doi: 10.1097/ANC.0000000000000395. — View Citation

Noergaard B, Ammentorp J, Garne E, Fenger-Gron J, Kofoed PE. Fathers' Stress in a Neonatal Intensive Care Unit. Adv Neonatal Care. 2018 Oct;18(5):413-422. doi: 10.1097/ANC.0000000000000503. — View Citation

Noergaard B, Johannessen H, Fenger-Gron J, Kofoed PE, Ammentorp J. Participatory Action Research in the Field of Neonatal Intensive Care: Developing an Intervention to Meet the Fathers' Needs. A Case Study. J Public Health Res. 2016 Dec 21;5(3):744. doi: — View Citation

Novak JC. Facilitating nurturant fathering behavior in the NICU. J Perinat Neonatal Nurs. 1990 Sep;4(2):68-77. — View Citation

Ortenstrand A, Westrup B, Broström EB, Sarman I, Akerström S, Brune T, Lindberg L, Waldenström U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25. — View Citation

Pohlman S. Fathering premature infants and the technological imperative of the neonatal intensive care unit: an interpretive inquiry. ANS Adv Nurs Sci. 2009 Jul-Sep;32(3):E1-16. doi: 10.1097/ANS.0b013e3181b0d68c. — View Citation

Pohlman S. The primacy of work and fathering preterm infants: findings from an interpretive phenomenological study. Adv Neonatal Care. 2005 Aug;5(4):204-16. — View Citation

Reid M, Lloyd D, Campbell G, Murray K, Porter M. Scottish neonatal intensive care units; a study of staff and parental attitudes. Health Bull (Edinb). 1995 Sep;53(5):314-25. — View Citation

Sullivan JR. Development of father-infant attachment in fathers of preterm infants. Neonatal Netw. 1999 Oct;18(7):33-9. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress (The Parental Stressor Scale: Neonatal Intensive Care Unit)	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.	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)
Primary	Parental Support (The Nurse Parent Support Tool)	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.	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)
Primary	Nurses self-efficacy (Self-efficacy (SE))	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".	Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)
Primary	Self-efficacy follow-up	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".	After the implementation of the intervention (January 2015) to five years after (February 2021).