Trial Outcomes & Findings for Sleep Disruption in New Mothers: An Intervention Trial (NCT NCT01321710)
NCT ID: NCT01321710
Last Updated: 2012-02-29
Results Overview
Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
COMPLETED
NA
152 participants
1-month postpartum (approximately)
2012-02-29
Participant Flow
Participant milestones
| Measure |
Dietary Information & Standard Care
Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care.
|
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 & Acetaminophen
Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
58
|
44
|
|
Overall Study
COMPLETED
|
46
|
53
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
0
|
Reasons for withdrawal
| Measure |
Dietary Information & Standard Care
Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care.
|
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 & Acetaminophen
Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
0
|
Baseline Characteristics
Sleep Disruption in New Mothers: An Intervention Trial
Baseline characteristics by cohort
| Measure |
Dietary Information & Standard Care
n=50 Participants
Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.
Infants in this arm receive standard immunization care.
|
Sleep Hygiene & Standard Care
n=58 Participants
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 & Acetaminophen
n=44 Participants
Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.
Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
152 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age Continuous
|
26.8 years
STANDARD_DEVIATION 6.5 • n=93 Participants
|
26.4 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
26.5 years
STANDARD_DEVIATION 7.1 • n=27 Participants
|
26.6 years
STANDARD_DEVIATION 6.6 • n=483 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
152 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
58 participants
n=4 Participants
|
44 participants
n=27 Participants
|
152 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 1-month postpartum (approximately)Population: ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.
Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.
Outcome measures
| Measure |
Dietary Information
n=32 Participants
Mothers in this group received dietary information for improving sleep.
|
Sleep Hygiene
n=77 Participants
Mothers in this group received sleep hygiene information
|
|---|---|---|
|
Maternal Sleep Quantity (Objective)
|
6.1 hours
Standard Deviation 1.4
|
6.6 hours
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 1 month postpartum (approximately)Population: ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.
Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.
Outcome measures
| Measure |
Dietary Information
n=32 Participants
Mothers in this group received dietary information for improving sleep.
|
Sleep Hygiene
n=77 Participants
Mothers in this group received sleep hygiene information
|
|---|---|---|
|
Maternal Sleep Quality (Objective)
|
68 percentage of sleep per time in bed
Standard Deviation 11
|
71 percentage of sleep per time in bed
Standard Deviation 10
|
PRIMARY outcome
Timeframe: 24 hours before and 24 hours after immunizations at approximately 2 months of agePopulation: ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.
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.
Outcome measures
| Measure |
Dietary Information
n=21 Participants
Mothers in this group received dietary information for improving sleep.
|
Sleep Hygiene
n=49 Participants
Mothers in this group received sleep hygiene information
|
|---|---|---|
|
Change in Infant Sleep Quantity (Objective)
|
47.4 minutes
Standard Deviation 133.3
|
73.1 minutes
Standard Deviation 151.8
|
SECONDARY outcome
Timeframe: 1 month postpartum (approximately)Population: ITT analysis.
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.
Outcome measures
| Measure |
Dietary Information
n=44 Participants
Mothers in this group received dietary information for improving sleep.
|
Sleep Hygiene
n=92 Participants
Mothers in this group received sleep hygiene information
|
|---|---|---|
|
Maternal Sleep Disturbance (Subjective)
|
49.9 Scores on a scale
Standard Deviation 17.9
|
49.4 Scores on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 1 month postpartum (approximately)Population: ITT analysis.
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.
Outcome measures
| Measure |
Dietary Information
n=44 Participants
Mothers in this group received dietary information for improving sleep.
|
Sleep Hygiene
n=91 Participants
Mothers in this group received sleep hygiene information
|
|---|---|---|
|
Maternal Well-being
|
13.3 Scores on a scale
Standard Deviation 7.7
|
13.0 Scores on a scale
Standard Deviation 7.9
|
Adverse Events
Dietary Information & Standard Care
Sleep Hygiene & Standard Care
Sleep Hygiene & Acetaminophen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kathryn Lee, RN, PhD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place