Clinical trial NCT00228215: Tips for Infant and Parent Sleep (TIPS)
Official title: Tips for Infant and Parent Sleep (TIPS) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: sleep
neonates
mothers
behavioural intervention
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2005-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night
timeFrame: 6 weeks postpartum
measure: Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991)
timeFrame: 6 weeks postpartum
measure: Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks
timeFrame: 6 weeks postpartum
measure: depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks
timeFrame: 6 weeks postpartum
measure: 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
timeFrame: 6 weeks postpartum
measure: 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
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's Health Sciences Centre - Women's College Campus
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Robyn Stremler, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.