Emotional Experiences in Fathers of NICU Infants

NCT ID: NCT00306605

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Stress Depressive Symptomatology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alfred I. duPont Hospital for Children

OTHER

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Amy Mackley

Amy Mackley

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy B. Mackley, MSN, RNC

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems

Michael L. Spear, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems; A.I. duPont Hospital for Children

Robert G. Locke, DO

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems; A.I. duPont Hospital for Children

Rachel Joseph, MSN, CCRN

Role: PRINCIPAL_INVESTIGATOR

Alfred I. duPont Hospital for Children

Locations

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Christiana Hospital (Christiana Care Health Systems)

Newark, Delaware, United States

Site Status

A.I. duPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/s1536-0903(03)00138-3.

Reference Type BACKGROUND
PMID: 14502526 (View on PubMed)

Other Identifiers

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26047

Identifier Type: -

Identifier Source: org_study_id

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