Kangaroo Holding and Maternal Stress
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2005 | ||||
| Last Updated Date | February 16, 2012 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in perceived maternal stress after kangaroo holding. [ Time Frame: 1 week ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00271115 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Kangaroo Holding and Maternal Stress | ||||
| Official Title ICMJE | The Effect of Kangaroo Holding on Maternal Stress Levels | ||||
| Brief Summary | The primary objective is to determine if kangaroo holding in the first week after birth influences the stress levels of mothers who have delivered their infants prematurely and who require admission to the Special Care Nursery (SCN). Hypothesis: There will be a decrease in maternal stress levels as perceived by mothers and as reflected in their blood pressures and heart rates after kangaroo holding their premature infants in the SCN. |
||||
| Detailed Description | This study builds on known observations by previous researchers that the birth and hospitalization of premature infants creates stressful events in the lives of parents (Shields-Poe & Pinelli, 1997). The challenge for health care workers is to provide for the physical and psychological needs of infants within a highly technological setting such as the SCN. It is necessary to facilitate effective bonding between parents and infants. Effective bonding is linked with successful parenting role development. Stress can alter the development of a positive parental role. Kangaroo holding, or skin-to-skin holding, involves placing a diaper clad infant vertical and prone between a mother's breasts (Affonso, 1993). As evidenced by the literature, stress can have an altering effect on the maternal attachment role psychologically and place physical demands on the cardiovascular system. Kangaroo care is one variable that may change the perception of maternal stress during preterm hospitalization by assisting mothers to gain control of the parental role, permitting maternal bonding and reducing maternal separation as well as potentially decreasing the allostatic load as associated with physiologic stress. This study will compare maternal perceived stress levels before and after kangaroo holding during the first week of life. Mothers who are enrolled in this study will be asked to Kangaroo hold their infants at least two times during the first week of life. The first kangaroo hold will take place with the first 48 hours of life. The second kangaroo hold will take place between day of life five and seven. Mothers may kangaroo hold their infants more than two times, however this study will only examine the kangaroo holding sessions that take place at the two times specified above. This study includes both physiologic and psychologic measurements. Mothers will have their blood pressure and heart rate measured before and after each of the two kangaroo holding sessions. These mothers will also be asked to complete a self-report stress inventory scale prior to the first kangaroo holding session (first 48 hours of infant's life) and again after the second kangaroo holding session (infant's day of life five to seven). |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: Kangaroo Holding
Mothers will be asked to Kangaroo hold their infants two times during the first week of life. |
||||
| Study Arm (s) | Moms w/preterm infants
Mothers of preterm infants who are admitted to the newborn intensive care unit.
Intervention: Behavioral: Kangaroo Holding |
||||
| Publications * |
|
||||
|
* 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 | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Mothers:
Infants:
Exclusion Criteria: Mothers:
Infants:
|
||||
| Gender | Female | ||||
| Ages | 20 Years to 40 Years | ||||
| 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 | NCT00271115 | ||||
| Other Study ID Numbers ICMJE | 25165 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christiana Care Health Services | ||||
| Study Sponsor ICMJE | Christiana Care Health Services | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Christiana Care Health Services | ||||
| Verification Date | February 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||