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

March 22, 2006
November 6, 2008
March 2006
September 2008   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00306605 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Stress levels fro fathers of hospitalized infants will decrease over time.
  • Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.
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Emotional Experiences in Fathers of NICU Infants
Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Stress
  • Depressive Symptomatology
Behavioral: Questionnaire
Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
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Miles MS, Brunssen SH. Psychometric properties of the parental stressor scale: infant hospitalization. Adv Neonatal Care. 2003 Aug;3(4):189-96.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2008
September 2008   (final data collection date for primary outcome measure)

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.
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00306605
26047
No
Amy Mackley, MSN, RNC, Christiana Hospital
Christiana Care Health Services
Alfred I. duPont Hospital for Children
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
Christiana Care Health Services
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP