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Clinical Trials/NCT00306605
NCT00306605CompletedNot Applicable

Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.

Christiana Care Health Services2 sites in 1 country35 target enrollmentStarted: March 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
2
Primary Endpoint
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.

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.(First 5 weeks after their infant's birth / hospitalization)
  • Stress levels for fathers of hospitalized infants will decrease over time.(Within the first 5 weeks of their infant's birth / hospitalization)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amy Mackley

Amy Mackley

Christiana Care Health Services

Study Sites (2)

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