Tips for Infant and Parent Sleep (TIPS)

Overview

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.

Full Title of Study: “Tips for Infant and Parent Sleep (TIPS) Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2005

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.

Interventions

  • Behavioral: TIPS Intervention
    • A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum

Arms, Groups and Cohorts

  • No Intervention: Usual care
  • Experimental: TIPS Intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Hours

Maximum Age: 7 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Hospital for Sick Children
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robyn Stremler, Nursing Research Associate – The Hospital for Sick Children
  • Overall Official(s)
    • Robyn Stremler, RN, PhD, Principal Investigator, The Hospital for Sick Children, Toronto Canada

Citations Reporting on Results

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.

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