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Sleep Disruption in New Mothers: An Intervention Trial (MOMS)

27. januar 2012 opdateret af: University of California, San Francisco

Sleep Disruption in New Parents: An Intervention Trial

The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143-0606
        • University of California

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • pregnant women expecting first singleton birth
  • able to speak, read, and write in English
  • willing to participate for 3 consecutive days and nights during 36-39 weeks gestation and at 4, 8, and 12 weeks postpartum
  • willing to have their infant participate in ankle actigraphy recording of their sleep/wake patterns for 96 hrs at the time of their first immunization

Exclusion Criteria:

  • history of affective illness prior to pregnancy
  • current use of medications that may alter sleep
  • history of a diagnosed sleep disorder such as sleep apnea, nocturnal myoclonus, or narcolepsy
  • plan to employ live-in help with child care
  • working the night-shift
  • multiple pregnancy with twins or more

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Dietary information & standard care

Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.

Infants in this arm receive no intervention beyond standard immunization care.
Adfærdsmæssigt: Dietary information
This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods.
Eksperimentel: Sleep hygiene & standard care

Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.

Infants in this arm receive standard immunization care.
Adfærdsmæssigt: Sleep hygiene

This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation.

It is administered to women during their last month of pregnancy.
Eksperimentel: Sleep hygiene & acetaminophen

Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.

Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.
Adfærdsmæssigt: Sleep hygiene

This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation.

It is administered to women during their last month of pregnancy.

Medicin: Acetaminophen
51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal Sleep Quantity (Objective)
Tidsramme: 1-month postpartum (approximately)
Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
1-month postpartum (approximately)
Maternal Sleep Quality (Objective)
Tidsramme: 1 month postpartum (approximately)
Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.
1 month postpartum (approximately)
Change in Infant Sleep Quantity (Objective)
Tidsramme: 24 hours before and 24 hours after immunizations at approximately 2 months of age
Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.
24 hours before and 24 hours after immunizations at approximately 2 months of age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal Sleep Disturbance (Subjective)
Tidsramme: 1 month postpartum (approximately)
Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.
1 month postpartum (approximately)
Maternal Well-being
Tidsramme: 1 month postpartum (approximately)
Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.
1 month postpartum (approximately)

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, San Francisco

Samarbejdspartnere

National Institute of Nursing Research (NINR)

Efterforskere

  • Ledende efterforsker: Kathryn A. Lee, RN, PhD, University of California, San Francisco

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.

Generelle publikationer

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. december 2004

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

22. marts 2011

Først indsendt, der opfyldte QC-kriterier

22. marts 2011

Først opslået (Skøn)

23. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MOMS Sleep
  • 2R01NR005345 (U.S. NIH-bevilling/kontrakt)

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 .

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    Det Forenede Kongerige

Kliniske forsøg med Dietary information

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Kosttilskud

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Placeringer

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