Text Size

Emotional Experiences in Fathers of NICU Infants

This study has been completed.
Sponsor:
Collaborator:
Alfred I. duPont Hospital for Children
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00306605
First received: March 22, 2006
Last updated: November 6, 2008
Last verified: November 2008
History of Changes
  Purpose

This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies.

Our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.

Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.


Condition Intervention
Stress
Depressive Symptomatology
 Behavioral: Questionnaire

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Perceived paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU. [ Time Frame: First 5 weeks of infant's life and / or hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stress levels for fathers of hospitalized infants will decrease over time. [ Time Frame: Within the first 5 weeks of their infant's birth / hospitalization ] [ Designated as safety issue: No ]
  • Depressive symptomatology modulates perceived stress in fathers of infants in NICUs. [ Time Frame: First 5 weeks after their infant's birth / hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2006
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Questionnaire
    Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
Detailed Description:

It is well known that birth and hospitalization of a preterm infant is stressful for parents. Numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. Researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the NICU. Studies examining paternal response alone have received less research attention. To date, no studies have compared the emotional response of fathers of medical NICU babies and fathers of surgical NICU babies.

The purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. Fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. Together these tools should take approximately 15-20 minutes to complete. Fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the NICU.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Fathers of preterm infants who are hospitalized in a newborn intensive care unit.

Criteria

Inclusion Criteria:

  • consenting fathers who are English speaking
  • fathers with preterm infants < 30 weeks gestation and who are likely to survive
  • Infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps.

Exclusion Criteria:

  • There are no specific exclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306605

Locations
United States, Delaware
Christiana Hospital (Christiana Care Health Systems)
Newark, Delaware, United States, 19718
A.I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
Sponsors and Collaborators
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Investigators
Principal Investigator: Amy B. Mackley, MSN, RNC Christiana Care Health Systems
Principal Investigator: Michael L. Spear, MD Christiana Care Health Systems; A.I. duPont Hospital for Children
Principal Investigator: Robert G. Locke, DO Christiana Care Health Systems; A.I. duPont Hospital for Children
Principal Investigator: Rachel Joseph, MSN, CCRN Alfred I. duPont Hospital for Children
  More Information

Publications:

Responsible Party: Amy Mackley, MSN, RNC, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00306605     History of Changes
Other Study ID Numbers: 26047
Study First Received: March 22, 2006
Last Updated: November 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Emotional experiences
fathers
stress
 depressive symptomatology
NICU
preterm birth

ClinicalTrials.gov processed this record on May 16, 2013