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| Sponsor: | Christiana Care Health Services |
|---|---|
| Information provided by: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00271115 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Premature Birth Maternal Stress |
Behavioral: Kangaroo Holding |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | The Effect of Kangaroo Holding on Maternal Stress Levels |
| Enrollment: | 20 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Moms w/preterm infants
Mothers of preterm infants who are admitted to the newborn intensive care unit.
|
Behavioral: Kangaroo Holding
Mothers will be asked to Kangaroo hold their infants two times during the first week of life.
|
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).
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Mothers:
Infants:
Exclusion Criteria:
Mothers:
Infants:
Contacts and Locations| United States, Delaware | |
| Christiana Hospital - Special Care Nursery | |
| Newark, Delaware, United States, 19718 | |
| Principal Investigator: | Karen A. Hall, BSN, RNC | Christiana Care Health Systems |
More Information
| Responsible Party: | Karen Hall, RNC, Christiana Hospital |
| ClinicalTrials.gov Identifier: | NCT00271115 History of Changes |
| Other Study ID Numbers: | 25165 |
| Study First Received: | December 21, 2005 |
| Results First Received: | March 30, 2010 |
| Last Updated: | January 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Kangaroo holding Kangaroo care Maternal stress levels Premature birth |
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |