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Tips for Infant and Parent Sleep (TIPS)

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TIPS Intervention
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Deprivation focused on measuring sleep, neonates, mothers, behavioural intervention

Eligibility Criteria

8 Hours - 7 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hospital for Sick Children
  • Sunnybrook & Women's Health Sciences Centre - Women's College Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

TIPS Intervention

Arm Description

Outcomes

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 assessed using a questionnaire at 6 weeks

Full Information

First Posted
September 26, 2005
Last Updated
September 11, 2019
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00228215
Brief Title
Tips for Infant and Parent Sleep (TIPS)
Official Title
Tips for Infant and Parent Sleep (TIPS) Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep, neonates, mothers, behavioural intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
TIPS Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
TIPS Intervention
Intervention Description
A behavioral-educational sleep intervention and support from a nurse in the immediate postpartum
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night
Time Frame
6 weeks postpartum
Title
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
Title
Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks
Time Frame
6 weeks postpartum
Title
depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks
Time Frame
6 weeks postpartum
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Hours
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Stremler, RN, PhD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Sunnybrook & Women's Health Sciences Centre - Women's College Campus
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17252892
Citation
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.
Results Reference
result

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Tips for Infant and Parent Sleep (TIPS)

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