StressNCT05521620
A Father-friendly Neonatal Intensive Care Unit
A study testing The father-friendly NICU in people with Stress and Self Efficacy, run by Kolding Sygehus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Self Efficacy, Perception, Self
- What is being tested?
- The father-friendly NICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2011to 11 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- fathers/mothers with infants admitted to the NICU were eligible
- nurses who work in Danish NICUs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Paediatrics and Adolescent Medicine at the University Hospital of Southern Denmark, Kolding
Kolding, 6000
About this study
Official title: What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?
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.
Read the 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
- 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.
- Conditions
- Stress, Self Efficacy, Perception, Self
- Being tested
- The father-friendly NICU
- Keywords
- Father, Intensive Care Units, Neonatal, Parental support, Stress, Self-efficacy, Mothers, Nurse, Participatory reseach, Masculinity
- Medical subject headings
- Masculinity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The father-friendly NICUBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Father-friendly NICU | Active comparator | * 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 Receives: Behavioral: The father-friendly NICU |
| No Father-friendly NICU (baseline) | No intervention | Baseline - before implementation of the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
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: 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)
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".
Measured: Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)
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".
Measured: After the implementation of the intervention (January 2015) to five years after (February 2021).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Dec 2011
- Primary completion31 Jan 2015
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A before- and-after intervention study
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betty Nørgaard, Kolding Sygehus
- Investigators
- Betty Noergaard, Ph.d, Principal investigator, Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital,Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521620
- Sponsor's protocol ID
- 19/20297
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual patient data (IPD) that underlie results in a publication
Publications
Meberg A, Wataker H. [Family-focused neonatal care]. Tidsskr Nor Laegeforen. 2010 Sep 9;130(17):1730-1. doi: 10.4045/tidsskr.10.0293. No abstract available. Norwegian.
PubMed 20835285Fegran 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.
PubMed 18279284Lindberg 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.
PubMed 18269426Sullivan JR. Development of father-infant attachment in fathers of preterm infants. Neonatal Netw. 1999 Oct;18(7):33-9. doi: 10.1891/0730-0832.18.7.33.
PubMed 10808886Mackley 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.
PubMed 20697219Pohlman 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.
PubMed 19707083Lundqvist P, Westas LH, Hallstrom I. From distance toward proximity: fathers lived experience of caring for their preterm infants. J Pediatr Nurs. 2007 Dec;22(6):490-7. doi: 10.1016/j.pedn.2007.04.008.
PubMed 18036470Kaaresen PI, Ronning 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. doi: 10.1542/peds.2005-1491.
PubMed 16818541Pohlman S. The primacy of work and fathering preterm infants: findings from an interpretive phenomenological study. Adv Neonatal Care. 2005 Aug;5(4):204-16. doi: 10.1016/j.adnc.2005.03.002.
PubMed 16084478Franck LS, Spencer C. Parent visiting and participation in infant caregiving activities in a neonatal unit. Birth. 2003 Mar;30(1):31-5. doi: 10.1046/j.1523-536x.2003.00214.x.
PubMed 12581037Lundqvist P, Jakobsson L. Swedish men's experiences of becoming fathers to their preterm infants. Neonatal Netw. 2003 Nov-Dec;22(6):25-31. doi: 10.1891/0730-0832.22.6.25.
PubMed 14700179Miles MS, Holditch-Davis D. Parenting the prematurely born child: pathways of influence. Semin Perinatol. 1997 Jun;21(3):254-66. doi: 10.1016/s0146-0005(97)80067-5.
PubMed 9205979Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom 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.
PubMed 20100748Johnson 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.
PubMed 19011495Arockiasamy 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.
PubMed 18182470
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?
- ClinicalTrials.gov ID
- NCT05521620
- Acronym / sponsor ID
- 19/20297
- Conditions
- Stress, Self Efficacy, Perception, Self
- Keywords
- Father, Intensive Care Units, Neonatal, Parental support, Stress, Self-efficacy, Mothers, Nurse, Participatory reseach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A before- and-after intervention study
| Arm | Type | Receives |
|---|---|---|
| Father-friendly NICU | Active comparator | 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 |
| No Father-friendly NICU (baseline) | No intervention | –Baseline - before implementation of the intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- fathers/mothers with infants admitted to the NICU were eligible
- nurses who work in Danish NICUs
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Father-friendly NICU |
Primary outcome
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.
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.
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".
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Background: PubMed 20835285Meberg A, Wataker H. [Family-focused neonatal care]. Tidsskr Nor Laegeforen. 2010 Sep 9;130(17):1730-1. doi: 10.4045/tidsskr.10.0293. No abstract available. Norwegian.
- Background: PubMed 18279284Fegran 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.
- Background: PubMed 18269426Lindberg 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.
- Background: PubMed 10808886Sullivan JR. Development of father-infant attachment in fathers of preterm infants. Neonatal Netw. 1999 Oct;18(7):33-9. doi: 10.1891/0730-0832.18.7.33.
- Background: PubMed 20697219Mackley 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.
- Background: PubMed 19707083Pohlman 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.
- Background: PubMed 18036470Lundqvist P, Westas LH, Hallstrom I. From distance toward proximity: fathers lived experience of caring for their preterm infants. J Pediatr Nurs. 2007 Dec;22(6):490-7. doi: 10.1016/j.pedn.2007.04.008.
- Background: PubMed 16818541Kaaresen PI, Ronning 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. doi: 10.1542/peds.2005-1491.
- Background: PubMed 16084478Pohlman S. The primacy of work and fathering preterm infants: findings from an interpretive phenomenological study. Adv Neonatal Care. 2005 Aug;5(4):204-16. doi: 10.1016/j.adnc.2005.03.002.
- Background: PubMed 12581037Franck LS, Spencer C. Parent visiting and participation in infant caregiving activities in a neonatal unit. Birth. 2003 Mar;30(1):31-5. doi: 10.1046/j.1523-536x.2003.00214.x.
- Background: PubMed 14700179Lundqvist P, Jakobsson L. Swedish men's experiences of becoming fathers to their preterm infants. Neonatal Netw. 2003 Nov-Dec;22(6):25-31. doi: 10.1891/0730-0832.22.6.25.
- Background: PubMed 9205979Miles MS, Holditch-Davis D. Parenting the prematurely born child: pathways of influence. Semin Perinatol. 1997 Jun;21(3):254-66. doi: 10.1016/s0146-0005(97)80067-5.
- Individual participant dataSharing planned: Yes. all individual patient data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Noergaard, Ph.d principal investigator
Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital,Kolding
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The father-friendly NICU in people with Stress and Self Efficacy, run by Kolding Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521620, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.