NCT00228215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 26, 2005

Last Update Submit

September 11, 2019

Conditions

Sleep Deprivation

Keywords

sleepneonatesmothersbehavioural intervention

Outcome Measures

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.

    6 weeks postpartum

Secondary Outcomes (6)

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

    6 weeks postpartum

  • Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991)

    6 weeks postpartum

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

    6 weeks postpartum

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

    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

    6 weeks postpartum

  • +1 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

TIPS Intervention

EXPERIMENTAL
Behavioral: TIPS Intervention

Interventions

TIPS InterventionBEHAVIORAL

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

TIPS Intervention

Eligibility Criteria

Age8 Hours - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Sunnybrook & Women's Health Sciences Centre - Women's College Campus

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 17252892RESULT

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Robyn Stremler, RN, PhD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Research Associate

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

CA(2)