Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial
- “Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial” by R Stremler and colleagues (BMJ 2013;346:f1164).
Objective—To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum period in improving maternal and infant sleep.
Design—Randomised controlled trial.
Setting—Postpartum units of two university affiliated hospitals in Canada.
Participants—246 primiparous women and their infants randomised while in hospital using 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 information on sleep 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 post partum to reinforce information, provide support, and solve problems. The usual care group received calls at weeks 1, 2, and 4 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 post partum by actigraphy (sleep-wake cycles assessed by measuring body movement). Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings measured 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 post partum 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 post partum 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 period, 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 post partum.
Why do the study?
Night waking is normal in early infancy: newborn babies lack an internal circadian rhythm and the diurnal patterning of sleep does not begin to emerge until 3 months of age. Sleep fragmentation and excessive tiredness are problematic for new parents. It is important, therefore, to devise and test interventions that help parents understand and prepare for the normal sleep patterns of a new baby, and to anticipate and cope with their own fatigue. Interventions that encourage the management of sleep needs in a prospective manner offer an alternative to “sleep training” interventions that are sometimes implemented in later infancy and are considered by many parents to be distressing, may only be of short term effectiveness, and may have negative consequences.
Previous studies    have reported longer, less fragmented sleep periods for infants who were recipients of various experimental interventions. However, in all cases the outcomes were measured via parental report using sleep diaries, rather than by objective measurement such as actigraphy (a technique that assesses sleep-wake cycles by measuring body movement). None of the previous trials included interventions to improve maternal sleep or examined the effects of the infant sleep intervention on maternal sleep outcomes.
In this study, Stremler and colleagues assessed whether an intervention they had devised and successfully piloted, involving sleep education and behavioural sleep management techniques, could improve maternal and infant sleep outcomes during the early postpartum period.
What did the authors do?
To test the effectiveness of their intervention (that is, whether or not it had a statistically significant and large enough effect to be robust), the authors conducted a randomised controlled trial. This study design is the ideal way to assess the effectiveness of interventions in clinical research, offering control of potential confounding factors (which should be equally distributed between the randomly allocated control and intervention arms of a trial).
In this trial, participants were recruited on the postpartum wards of two hospitals in Canada. Steps were taken to limit the possibility of contamination (where participants affect one another’s knowledge or behaviour). Eligibility criteria ensured that all mothers and babies were healthy and that the women were able to understand and participate in the trial, were first time mothers, and intended to spend the study period caring full time for their infant.
Overall, 246 participants were assigned to either the control (n=123) or the intervention (n=123) group using an external web based randomisation service, thus preventing the problems inherent in “sealed envelope” type allocations where staff may be tempted or persuaded to offer or assign an alternative allocation in response to the characteristics of participants or request. Allocations were assigned in blocks of four and six and stratified by centre, ensuring that the number of participants in each arm of the trial remained equal. In a behavioural intervention it is not possible to conceal the allocation group from the participants in the same way as one might in a drug trial. This introduces the possibility of inflated benefit perception (when participants in the intervention group over-exaggerate the benefits) and is one reason why assessing the outcomes of infant sleep interventions via parental report may not be accurate—hence the value of actigraphy.
Control mothers and babies received care as usual. Those in the experimental group received the behavioural-educational intervention as soon as possible after randomisation and before discharge from hospital. The intervention comprised 45-60 minutes’ discussion of mother and baby sleep problems, strategies to improve both, and support and encouragement around the women’s ability to achieve good sleep for themselves and their infant. The women received a booklet to refer to at home and support phone calls at one, two, and four weeks after discharge. Consistency in the delivery of the intervention was checked before and throughout the trial by audiotaping the interactions between participants and nurses.
Data were collected for both infant and maternal sleep via actigraphy (providing an objective measure of the duration of sleep and wakefulness), sleep diaries, and questionnaires (allowing for subjective assessment of outcomes and interpretation of actigraphy data) when the infant reached 6 and 12 weeks of age.
The intervention methods used in this study had previously been piloted (30 participants). This provided data for power calculations to determine the appropriate sample size and ensured that the intervention and follow-up methods were assessed for acceptability. Attempts to make the trial intervention pragmatic (financially and practically viable for real world implementation) were made after the pilot study, and this adjusted the information given and the number of follow-up phone calls, which may have affected the outcome.
What did the study find?
The primary outcome was maternal sleep duration between 9 pm and 9 am; the secondary outcome was the duration of the infant’s longest period of nocturnal sleep. No significant differences were found between groups for any of the objectively measured sleep outcomes at either six or 12 weeks. The estimated mean difference between trial arms in mothers’ night time sleep was 5.97 minutes (95% confidence interval −7.55 to 19.5 minutes; P=0.39). At 12 weeks slightly more intervention group mothers were exclusively breast feeding (69% v 66%) but the difference was not significant (relative risk of exclusive breast feeding 1.04, 95% confidence interval 0.86 to 1.26; P=0.66). Fatigue, depression, or sleep disturbance scores obtained using standard questionnaires did not differ.
|Outcomes||Median (interquartile range)|
|Sleep intervention*||Usual care†|
|Nocturnal sleep (minutes):|
|6 weeks||397 (362-428)||387 (359-424)|
|12 weeks||440 (402-469)||431 (396-468)|
|Longest stretch of nocturnal sleep (minutes):|
|6 weeks||144 (114-174)||136 (114-167)|
|12 weeks||153 (125-208)||155 (122-192)|
|No of night awakenings:|
|6 weeks||8.8 (6.8-11.5)||9.3 (6.9-11.3)|
|12 weeks||9.3 (5.5-12.0)||9.0 (6.7-12.0)|
|Daytime sleep (minutes):|
|6 weeks||34 (15-70)||45 (24-72)|
|12 weeks||32 (6.7-67)||35 (15-64)|
What are the strengths and limitations of this study?
The major strengths of the study were the randomised design, standardisation of the intervention, and use of actigraphy for objective measurement of sleep duration.
Opt-in recruitment strategies tend to produce a participant demographic that is older and better educated than the population from which the sample is drawn. This was the case here, and is important as the intervention required engagement with an educational process, and supporting materials required 20 pages of reading. The study therefore cannot assess whether this is an effective intervention for a younger or less well educated group of mothers. However, the reluctance of these groups to engage with the trial suggests that they may find this type of intervention unappealing. Stratified sampling on the basis of sociodemographic groupings would be needed to eliminate this problem.
Recruitment on the postpartum ward resulted in a sampling bias towards women experiencing caesarean birth owing to their longer hospital stay (this was particularly unbalanced between control and intervention groups, 46% v 35%). Sleep disruption exacerbated by incision pain may have affected the maternal sleep outcomes.
The major limitation of the study was the timing of the primary and secondary outcome measures: the goal of “improving” maternal or infant sleep in the first 12 weeks of life was inappropriate given the nature of infant sleep development—a fact acknowledged by the authors in their discussion.
What does the study mean?
Early infant night waking is not pathological, and the infant does not require treatment. Healthcare providers can influence perceptions by refraining from asking whether a young baby “sleeps through the night,” as this reinforces the idea that prolonged infant sleep is important and should be achieved early.
Interventions that assist parents in achieving sufficient sleep during the transition to life with a new baby are appropriate, but must recognise the importance and normality of frequent night waking and feeding. We should avoid making parents think that it is desirable to attempt to manipulate infant sleep behaviour during the first three months of life—this study shows that educational and behavioural interventions are unlikely to alter sleep duration in the first three months post partum. What needs to be assessed now is whether such interventions can help parents develop resilience and coping strategies that enable them to traverse this period with a manageable impact on their mental and physical wellbeing.Helen L Ball, professor, Charlotte K Russell, postdoctoral research associate
1Parent-Infant Sleep Laboratory, Department of Anthropology, Durham University, Durham DH1 3LE, UK
Correspondence to: email@example.com
Competing interests: HLB and CKR run the Infant Sleep Information Source (ISIS), an online source of infant sleep research information for parents and health professionals (www.isisonline.org.uk). They do so as part of their academic outreach activities and do not receive any income from the project.
Provenance and peer review: Commissioned; not externally peer reviewed.
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Cite this as: BMJ 2013;21:f3351