The TIPS (Tips for Infant and Parent Sleep) trial
| ISRCTN | ISRCTN13501166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13501166 |
| Secondary identifying numbers | MCT-84658 |
- Submission date
- 03/07/2008
- Registration date
- 03/07/2008
- Last edited
- 28/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robyn Stremler
Scientific
Scientific
Faculty of Nursing
University of Toronto
Room 288, 155 College Street
Toronto
M5T 1P8
Canada
| Phone | +1 416 978 6925 |
|---|---|
| robyn.stremler@utoronto.ca |
Study information
| Study design | Randomised, blinded (investigator, data analyst, research nurse), parallel assignment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Tips for Infant and Parent Sleep: a randomised, blinded, parallel assignment trial |
| Study acronym | TIPS |
| Study objectives | Primary question: Compared to usual care, what is the effect of a behavioural-educational sleep intervention in the early postpartum on maternal nocturnal sleep? Secondary question: Compared to usual care, what is the effect of a behavioural-educational sleep intervention in the early postpartum on length of an infant's longest nocturnal sleep period? Additional research questions will address the effects of a behavioural-educational sleep intervention in the early postpartum on: maternal nighttime awakenings, infant nighttime awakenings, maternal sleep disturbance, depressive symptomatology, maternal morning fatigue, and breastfeeding. Please note that as of 04/03/2009 the anticipated end date in this record was amended; the previous date was as follows: Initial anticipated end date: 01/12/2008 |
| Ethics approval(s) | Ethics committees of: 1. Sunnybrook Health Sciences Centre, Toronto approved on the 27th November 2007 2. St Michael's Hospital, Toronto approved on the 4th February 2008 3. University of Toronto approved on the 9th March 2007 |
| Health condition(s) or problem(s) studied | Sleep disorders |
| Intervention | Experimental: TIPS (45-minute behavioural-educational session with a Research Nurse [RN] in hospital, 20-page booklet, 3 phone calls at home in the postpartum). Control: Usual care (three phone calls at home to provide attention only). |
| Intervention type | Other |
| Primary outcome measure | Maternal nocturnal (9 pm - 9 am) sleep (in minutes) as measured at 6 and 12 weeks postpartum. |
| Secondary outcome measures | Infant's longest nocturnal (9 pm - 9 am) sleep period (in minutes) as measured at 6 and 12 weeks postpartum. |
| Overall study start date | 30/05/2008 |
| Completion date | 15/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 234 |
| Key inclusion criteria | 1. Women (single or partnered), no age limit 2. Have given birth for the first time 3. Have a singleton baby born at gestational age (GA) greater than or equal to 37 weeks 4. Have a baby described as healthy in the newborn examination 5. Live in the greater Toronto area 6. Plan to provide full time infant care for at least the first 12 weeks after birth 7. Women with previous miscarriages at less than 20 weeks GA are eligible if the most recent pregnancy resulted in a first child |
| Key exclusion criteria | 1. Women or women whose partners have experienced stillbirth or perinatal death at greater than or equal to 20 weeks GA 2. Women whose partners have children from another relationship 3. Maternal or infant complications requiring prolonged hospital stay 4. Maternal chronic illness that is poorly controlled 5. Maternal use of medications that affect sleep (e.g. benzodiazepines) 6. Maternal (or partner, if they exist) drug or alcohol use beyond social use 7. Women (or partners, if one exists) with a diagnosed sleep disorder (e.g. sleep apnoea, narcolepsy) 8. Mother's partner, if one exists, is working night shifts 9. Mother unable to read or understand English 10. No telephone in the home 11. Involvement in another research study involving sleep |
| Date of first enrolment | 30/05/2008 |
| Date of final enrolment | 15/04/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
Faculty of Nursing
Toronto
M5T 1P8
Canada
M5T 1P8
Canada
Sponsor information
University of Toronto (Canada)
University/education
University/education
27 King's College Circle
Toronto
M5S 1A1
Canada
| Website | http://www.utoronto.ca/ |
|---|---|
"ROR" |
https://ror.org/03dbr7087 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-84658)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/03/2013 | Yes | No |
