Tips for Infant and Parent Sleep (TIPS)

Sleep Deprivation Clinical Trial

Official title:

Tips for Infant and Parent Sleep (TIPS) Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228215
• Other study ID #: 1000007776
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Est. completion date: December 2005

Study information

• Verified date: September 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook & Women's Health Sciences Centre - Women's College Campus	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant recording of sleep times, wake times, and events that occurred that might have affected sleep for the night		6 weeks postpartum
Secondary	Morning and evening fatigue measured by the Fatigue Visual Analogue Scale (Fatigue-VAS) at 6 weeks (Lee et al., 1991)		6 weeks postpartum
Secondary	Sleep disturbance measured using the General Sleep Disturbance Scale (GSDS) at both baseline and 6 weeks		6 weeks postpartum
Secondary	depressive symptomatology measured with the Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987)at baseline and 6 weeks		6 weeks postpartum
Secondary	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
Secondary	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		6 weeks postpartum