Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trialBMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1164 (Published 20 March 2013) Cite this as: BMJ 2013;346:f1164
- Robyn Stremler, assistant professor and adjunct scientist12,
- Ellen Hodnett, professor1,
- Laura Kenton, trial coordinator1,
- Kathryn Lee, professor3,
- Shelly Weiss, staff neurologist and assistant professor24,
- Julie Weston, senior trial coordinator1,
- Andrew Willan, senior scientist and professor25
- 1Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada
- 2Hospital for Sick Children (SickKids), Toronto, ON, Canada
- 3Department of Family Health Care Nursing, University of San Francisco, CA, USA
- 4Department of Pediatrics, University of Toronto, Toronto, ON, Canada
- 5Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
- Correspondence to: R Stremler, Lawrence S Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Toronto, ON, Canada, M5T 1P8
- Accepted 12 February 2013
Objective To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum in improving maternal and infant sleep.
Design Randomised controlled trial.
Setting Postpartum units of two university affiliated hospitals.
Participants 246 primiparous women and their infants randomised while in hospital with an internet based randomisation service to intervention (n=123) or usual care (n=123) groups.
Interventions The behavioural-educational sleep intervention included a 45-60 minute meeting with a nurse to discuss sleep information and strategies to promote maternal and infant sleep, a 20 page booklet with the content discussed, and phone contacts at one, two, and four weeks postpartum to reinforce information, provide support, and problem solve. The usual care group received calls at weeks one, two, and four to maintain contact without provision of advice.
Main outcome measures Primary outcome was maternal nocturnal (9 pm to 9 am) sleep (minutes) and secondary outcome was longest stretch of infant nocturnal sleep (minutes) measured at six and 12 weeks postpartum by actigraphy. Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings by actigraphy, fatigue visual analogue scale, general sleep disturbance scale, and Edinburgh postnatal depression scale. Rates of exclusive breast feeding were measured at 12 weeks postpartum only.
Results All women who completed any outcome measures at six or 12 weeks were included in analysis. Sleep outcomes were completed at one or both of six and 12 weeks postpartum for 215 of 246 (87%) women (110/123 intervention and 105/123 usual care). Longitudinal mixed effects model analyses indicated no significant differences between the groups on any of the outcomes. The estimated mean difference in maternal nocturnal sleep between the intervention and usual care groups was 5.97 minutes (95% confidence interval −7.55 to 19.5 minutes, P=0.39). No differences in any outcomes were noted based on the specific nurse delivering the intervention or the number of phone contacts received.
Conclusion A behavioural-educational intervention delivered in the early postpartum, in hospital, and in the first weeks at home, was ineffective in improving maternal and infant sleep or other health outcomes in the first months postpartum.
Trial registration ISRCT No 13501166.
We thank the families who participated in the study and shared their experiences with us, and the staff of the postpartum units at Sunnybrook Health Sciences Centre and St Michael’s Hospital for their assistance.
Contributors: RS (principal investigator) conceptualised and designed the trial, obtained funding, directed implementation, completed data analysis and interpretation, wrote the draft manuscript, and is guarantor. EH and KL (co-investigators) assisted in all trial activities including design, funding, implementation, data interpretation, and manuscript preparation. LK (trial coordinator) assisted in all trial implementation procedures including participant recruitment, overseeing intervention implementation and data collection procedures, and performing database management activities. SW (co-investigator) assisted in trial funding and data interpretation and was available for clinical consultation during implementation. JW (senior trial coordinator) assisted in all trial activities including design, funding, budget management, data interpretation, and manuscript preparation and all trial implementation procedures including completing participant recruitment, overseeing intervention implementation, and data collection procedures, and performing database management activities. AW (co-investigator and biostatistician) assisted in design, funding, data analysis and interpretation, and manuscript preparation. All authors have commented on the manuscript.
Funding: This work was funded by a Canadian Institutes of Health research grant (No MCT 84658). This trial was conducted and data analysed with complete independence of the researchers from the Canadian Institutes of Health Research. RS is recipient of a Canadian Institutes of Health Research new investigator award and an Ontario Ministry of Research and Innovation early researcher award.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the University of Toronto research ethics board and the ethical review boards of the two participating hospitals (St Michael’s Hospital, Toronto, Ontario, Canada, Approval ID: REB 07-303; Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, Approval ID: 371-2007) and informed consent was given by all participants.
Data sharing: No additional data available.
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