- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00271115
Kangaroo Holding and Maternal Stress
The Effect of Kangaroo Holding on Maternal Stress Levels
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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).
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Delaware
-
Newark, Delaware, Stany Zjednoczone, 19718
- Christiana Hospital - Special Care Nursery
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Inny: Moms w/preterm infants
Mothers of preterm infants who are admitted to the newborn intensive care unit.
|
Mothers will be asked to Kangaroo hold their infants two times during the first week of life.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
Change in perceived maternal stress after kangaroo holding.
Ramy czasowe: 1 week
|
1 week
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Karen A. Hall, BSN, RNC, Christiana Care Health Systems
Publikacje i pomocne linki
Publikacje ogólne
- Miles MS, Funk SG, Kasper MA. The stress response of mothers and fathers of preterm infants. Res Nurs Health. 1992 Aug;15(4):261-9. doi: 10.1002/nur.4770150405.
- Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Affonso D, Bosque E, Wahlberg V, Brady JP. Reconciliation and healing for mothers through skin-to-skin contact provided in an American tertiary level intensive care nursery. Neonatal Netw. 1993 Apr;12(3):25-32.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 25165
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Kangaroo Holding
-
University of Alabama at BirminghamZakończony
-
Firat UniversityZakończony
-
University of Alabama at BirminghamZakończony
-
Meir Medical CenterZakończony
-
Universidad de la SabanaClínica Palermo; Hospital MeissenRekrutacyjnyPóźna posocznica noworodkówKolumbia
-
Meir Medical CenterZakończonyPrzedwczesny poród | Reakcja stresowaIzrael
-
Istituto Clinico HumanitasZakończony
-
University of South CarolinaGhana Health Services; Korle-Bu Teaching Hospital, Accra, Ghana; Centre for Learning...Jeszcze nie rekrutacjaHipotermia noworodkówGhana
-
Hacettepe UniversityZakończonyUżytkownik protezy | CyfryzacjaIndyk
-
Akron Children's HospitalZakończonyStan astmatycznyStany Zjednoczone