Emotional Experiences in Fathers of NICU Infants
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 22, 2006 | ||||||||||||||||
| Last Updated Date | November 6, 2008 | ||||||||||||||||
| Start Date ICMJE | March 2006 | ||||||||||||||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE |
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. | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00306605 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Emotional Experiences in Fathers of NICU Infants | ||||||||||||||||
| Official Title ICMJE | Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs. | ||||||||||||||||
| 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 Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||
| Study Population | Fathers of preterm infants who are hospitalized in a newborn intensive care unit. |
||||||||||||||||
| Condition ICMJE |
|
||||||||||||||||
| Intervention ICMJE | Behavioral: Questionnaire
Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization |
||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||
| Publications * | 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. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||||||||||
| Completion Date | November 2008 | ||||||||||||||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
| Gender | Male | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00306605 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 26047 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Amy Mackley, MSN, RNC, Christiana Hospital | ||||||||||||||||
| Study Sponsor ICMJE | Christiana Care Health Services | ||||||||||||||||
| Collaborators ICMJE | Alfred I. duPont Hospital for Children | ||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | Christiana Care Health Services | ||||||||||||||||
| Verification Date | November 2008 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||