Emotional Experiences in Fathers of NICU Infants

June 19, 2017 updated by: Amy Mackley, Christiana Care Health Services

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Questionnaire

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Delaware
  - Newark, Delaware, United States, 19718
    - Christiana Hospital (Christiana Care Health Systems)
  - Wilmington, Delaware, United States, 19899
    - A.I. duPont Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	First 5 weeks of infant's life and / or hospitalization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

26047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.