Tips for Infant and Parent Sleep (TIPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by The Hospital for Sick Children.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00228215
First received: September 26, 2005
Last updated: March 11, 2010
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Sleep Deprivation
Behavioral: counselling on maternal and infant sleep behavior
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tips for Infant and Parent Sleep (TIPS) Pilot Study

Further study details as provided by The Hospital for Sick Children:

Primary Outcome 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228215

Locations
Canada, Ontario
Sunnybrook & Women's Health Sciences Centre - Women's College Campus
Toronto, Ontario, Canada, M5S 1B2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Robyn Stremler, RN, PhD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Robyn Stremler, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00228215     History of Changes
Other Study ID Numbers: 1000007776
Study First Received: September 26, 2005
Last Updated: March 11, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
sleep
neonates
mothers
behavioural intervention

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders

ClinicalTrials.gov processed this record on October 23, 2014