Sleep Disruption in New Mothers: An Intervention Trial

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Disruption in New Parents: An Intervention Trial

Conditions
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Pregnancy, Postpartum Period, Sleep Disturbance

Intervention / Treatment
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* Behavioral: Sleep hygiene
* Behavioral: Dietary information
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary information & standard care<br>Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive no intervention beyond standard immunization care. | Behavioral: Dietary information<br>* 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.<br>|
| Experimental: Sleep hygiene & standard care<br>Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care. | Behavioral: Sleep hygiene<br>* 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.<br>|
| Experimental: Sleep hygiene & acetaminophen<br>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. | Behavioral: Sleep hygiene<br>* 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.<br>Drug: Acetaminophen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Sleep Quantity (Objective) | 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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Sleep Disturbance (Subjective) | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep hygiene, actigraphy, maternal, infant, postpartum period, immunization, acetaminophen