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Tips for Infant and Parent Sleep (TIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00228215
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Robyn Stremler, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date September 13, 2019
Study Start Date  ICMJE September 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
- 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.
Change History Complete list of historical versions of study NCT00228215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
  • Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night [ Time Frame: 6 weeks postpartum ]
  • 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 ]
  • Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks [ Time Frame: 6 weeks postpartum ]
  • depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 weeks postpartum ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tips for Infant and Parent Sleep (TIPS)
Official Title  ICMJE Tips for Infant and Parent Sleep (TIPS) Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sleep Deprivation
Intervention  ICMJE Behavioral: TIPS Intervention
A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
Study Arms  ICMJE
  • No Intervention: Usual care
  • Experimental: TIPS Intervention
    Intervention: Behavioral: TIPS Intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2014)
30
Original Enrollment  ICMJE
 (submitted: September 26, 2005)
40
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228215
Other Study ID Numbers  ICMJE 1000007776
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robyn Stremler, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robyn Stremler, RN, PhD The Hospital for Sick Children, Toronto Canada
PRS Account The Hospital for Sick Children
Verification Date September 2019

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