Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2004-12-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kathryn A. Lee, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California
San Francisco, California, United States
Countries
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References
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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.
Other Identifiers
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MOMS Sleep
Identifier Type: -
Identifier Source: org_study_id