- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01321710
Sleep Disruption in New Mothers: An Intervention Trial (MOMS)
Sleep Disruption in New Parents: An Intervention Trial
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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California
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San Francisco, California, Forente stater, 94143-0606
- University of California
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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. |
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.
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Eksperimentell: 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. |
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. |
Eksperimentell: 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. |
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.
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maternal Sleep Quantity (Objective)
Tidsramme: 1-month postpartum (approximately)
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Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
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1-month postpartum (approximately)
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Maternal Sleep Quality (Objective)
Tidsramme: 1 month postpartum (approximately)
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Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.
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1 month postpartum (approximately)
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Change in Infant Sleep Quantity (Objective)
Tidsramme: 24 hours before and 24 hours after immunizations at approximately 2 months of age
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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.
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24 hours before and 24 hours after immunizations at approximately 2 months of age
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maternal Sleep Disturbance (Subjective)
Tidsramme: 1 month postpartum (approximately)
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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.
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1 month postpartum (approximately)
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Maternal Well-being
Tidsramme: 1 month postpartum (approximately)
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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.
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1 month postpartum (approximately)
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kathryn A. Lee, RN, PhD, University of California, San Francisco
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lee KA, Gay CL. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials. Res Nurs Health. 2011 Feb;34(1):7-19. doi: 10.1002/nur.20413. Epub 2010 Nov 17.
- Goyal D, Gay C, Lee KA. How much does low socioeconomic status increase the risk of prenatal and postpartum depressive symptoms in first-time mothers? Womens Health Issues. 2010 Mar-Apr;20(2):96-104. doi: 10.1016/j.whi.2009.11.003. Epub 2010 Feb 4.
- Kennedy HP, Gardiner A, Gay C, Lee KA. Negotiating sleep: a qualitative study of new mothers. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):114-22. doi: 10.1097/01.JPN.0000270628.51122.1d.
- Franck L, Gay CL, Lynch M, Lee KA. Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen. Pediatrics. 2011 Dec;128(6):1100-8. doi: 10.1542/peds.2011-1712. Epub 2011 Nov 28.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MOMS Sleep
- 2R01NR005345 (U.S. NIH-stipend/kontrakt)
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