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Tips for Infant and Parent Sleep (TIPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robyn Stremler, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00228215
First received: September 26, 2005
Last updated: November 18, 2014
Last verified: November 2014

September 26, 2005
November 18, 2014
September 2005
December 2005   (final data collection date for primary outcome 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. [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
- 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.
Complete list of historical versions of study NCT00228215 on ClinicalTrials.gov Archive Site
  • Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991) [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • - Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night.
  • - Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991).
  • - Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks
  • - depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks
  • - 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
  • - intervention use, perceived helpfulness of interventions, satisfaction with TIPS Pilot study involvement, and preferences for interventions and data collection methods will be assesed using a questionnaire at 6 weeks
Not Provided
Not Provided
 
Tips for Infant and Parent Sleep (TIPS)
Tips for Infant and Parent Sleep (TIPS) Pilot Study

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Sleep Deprivation
Behavioral: TIPS Intervention
A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
  • No Intervention: Usual care
  • Experimental: TIPS Intervention
    Intervention: Behavioral: TIPS Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
up to 7 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00228215
1000007776
No
Robyn Stremler, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Robyn Stremler, RN, PhD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP