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A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later.
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the infant, development of the infant's sleep physiology, maternal sleep habits and behaviors, and maternal feelings related to her sleep and her baby's sleep. These factors may be modifiable through the use of behavioral-educational interventions. A randomized controlled trial design will be used to answer whether a behavioral-educational sleep intervention and support from a nurse in the immediate postpartum improves maternal and infant sleep 6 weeks later. Sleep-wake patterns will be analyzed through the use of actigraphy, a wristwatch-like device that measures sleep-wake activity. This is a pilot study which will test the usefulness and practicality of this type of program, so that a larger scale study can be developed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | ||
| TIPS Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPS Intervention | Behavioral | A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep outcomes (nocturnal sleep duration, total daily sleep time, time awake after sleep onset, number of night wakings, length of longest sleep periods) for women and their infants will be measured using actigraphy at 6 weeks. | 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night | 6 weeks postpartum | |
| Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Stremler, RN, PhD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada | ||
| Sunnybrook & Women's Health Sciences Centre - Women's College Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17252892 | Result | Stremler R, Hodnett E, Lee K, MacMillan S, Mill C, Ongcangco L, Willan A. A behavioral-educational intervention to promote maternal and infant sleep: a pilot randomized, controlled trial. Sleep. 2006 Dec;29(12):1609-15. doi: 10.1093/sleep/29.12.1609. |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| 6 weeks postpartum |
| Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks | 6 weeks postpartum |
| depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks | 6 weeks postpartum |
| levels of relatively transient, situation-related (state) anxiety as measured by the State-Trait Anxiety Inventory, state-anxiety subscale (Spielberger, 1970)at baseline and 6 weeks | 6 weeks postpartum |
| intervention use, perceived helpfulness of interventions, satisfaction with TIPS Pilot study involvement, and preferences for interventions and data collection methods will be assessed using a questionnaire at 6 weeks | 6 weeks postpartum |
| Toronto |
| Ontario |
| M5S 1B2 |
| Canada |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |