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Kangaroo Holding and Maternal Stress

16. februar 2012 opdateret af: Christiana Care Health Services

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Delaware
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Hospital - Special Care Nursery

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in perceived maternal stress after kangaroo holding.
Tidsramme: 1 week
1 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Karen A. Hall, BSN, RNC, Christiana Care Health Systems

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Primær færdiggørelse (Faktiske)

1. oktober 2007

Studieafslutning (Faktiske)

1. januar 2008

Datoer for studieregistrering

Først indsendt

21. december 2005

Først indsendt, der opfyldte QC-kriterier

29. december 2005

Først opslået (Skøn)

30. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med For tidlig fødsel

Kliniske forsøg med Kangaroo Holding

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