Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271115
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-12-21
Brief Title:
Kangaroo Holding and Maternal Stress
Sponsor:
Christiana Care Health Services
Organization:
Christiana Care Health Services
Study Overview
Official Title:
The Effect of Kangaroo Holding on Maternal Stress Levels
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mothers 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 infants life and again after the second kangaroo holding session infants day of life five to seven
Kangaroo holding or skin-to-skin holding involves placing a diaper clad infant vertical and prone between a mothers 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 infants life and again after the second kangaroo holding session infants day of life five to seven
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None