Tips for Infant and Parent Sleep (TIPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Deprivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

TIPS Intervention

Group Type EXPERIMENTAL

TIPS Intervention

Intervention Type BEHAVIORAL

A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum

Interventions

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TIPS Intervention

A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Singleton baby born at GA \>37 weeks
* baby 8 hours to 7 days old
* Mother age 16-50 years
* Normal, healthy infant as described in newborn examination
* First time parents living in the Greater Toronto Area
* Mother planning to provide fulltime care to her infant for at least the first six weeks after discharge home

Exclusion Criteria

* Maternal or infant complications requiring prolonged hospital stay
* Previous stillbirth or neonatal death
* Maternal chronic illness
* Maternal use of medications that affect sleep (e.g. benzodiazepines, any sleep aid)
* Known drug or alcohol use beyond occasional social use
* Smoking two packs a day or more
* Either parent has a diagnosed sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
* Mother's partner is working night shifts
* Mother unable to read or understand English
* No telephone in the home
* Involvement in another research protocol involving sleep

Minimum Eligible Age

8 Hours

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes