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Completed

NCT Number: NCT00228215

Tips for Infant and Parent Sleep (TIPS)

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.

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Key information

Age range

8 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook & Women's Health Sciences Centre - Women's College Campus, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIPS Intervention

Behavioral

A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum

Primary outcomes

  1. 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 outcomes

  1. Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night

    Time frame: 6 weeks postpartum

  2. 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

  3. Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks

    Time frame: 6 weeks postpartum

  4. depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks

    Time frame: 6 weeks postpartum

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Tips for Infant and Parent Sleep (TIPS) Pilot Study

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 28, 2005
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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