Tips for Infant and Parent Sleep (TIPS)

Study Overview
=================
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.

Official Title
-----------------
Tips for Infant and Parent Sleep (TIPS) Pilot Study

Conditions
-----------------
Sleep Deprivation

Intervention / Treatment
-----------------
* Behavioral: TIPS Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Hours
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br> | |
| Experimental: TIPS Intervention<br> | Behavioral: TIPS Intervention<br>* A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, neonates, mothers, behavioural intervention