Kangaroo Holding and Maternal Stress

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00271115
First received: December 21, 2005
Last updated: February 16, 2012
Last verified: February 2012
  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

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Change in perceived maternal stress after kangaroo holding. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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.

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).

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Mothers:

  • Delivered a premature infant between 30 0/7 and 33 6/7 weeks gestation
  • 20 to 40 years old
  • English speaking

Infants:

  • Admitted to Special Care Nursery and on a monitor
  • Medically stable enough to be held (determined by health care team)

Exclusion Criteria:

Mothers:

  • Multiple birth
  • Eclampsia
  • Pre-existing hypertension or at risk (BP above 140/90)
  • Pre-existing cardiac disease
  • HELLP syndrome, or uncontrolled medical condition during pregnancy
  • Use of magnesium sulfate for blood pressure control prior to delivery
  • Known depression or treatment with antidepressants

Infants:

  • Congenital anomalies
  • Use of NCPAP or mechanical ventilation
  • medically unstable (as determined by health care team)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271115

Locations
United States, Delaware
Christiana Hospital - Special Care Nursery
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Karen A. Hall, BSN, RNC Christiana Care Health Systems
  More Information

Publications:
Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00271115     History of Changes
Other Study ID Numbers: 25165
Study First Received: December 21, 2005
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Kangaroo holding
Kangaroo care
Maternal stress levels
Premature birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014