The Baseline questionnaires include:
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1.
Pittsburgh Sleep Quality Index (PSQI)
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2.
Insomnia Severity Index (ISI)
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3.
Multidimensional Assessment of Fatigue (MAF) scale
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4.
Epworth Sleepiness Scale (ESS)
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5.
Edinburgh Post Natal Depression Scale (EPDS)
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6.
Depression, Anxiety and Stress Scale (DASS)
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7.
Brief Coping Scale (COPE)
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8.
The General Self-Efficacy Scale (SES)
Post-delivery questionnaires include the baseline questionnaires as well as the questionnaires listed below:
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9.
Infant characteristics questionnaire (ICQ)
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10.
General feeding questionnaire
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11.
General sleeping questionnaire
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12.
Being a Mother & Bonding Scale – BaMB
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13.
Maternal sleep diary
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14.
Infant sleep diary
A description of all the questionnaires these can be found in Appendix: Questionnaires.
The Maternal and Infant sleep diaries are designed to record sleep hours for three consecutive days. There will be the option to complete these via a specially designed phone application instead of online for those who find it more convenient.
In the interest of efficiency and in order to minimise the number of questionnaires completed by the participants, the Brief COPE questionnaire, The Infant Characteristics Questionnaire and the General Feeding Questionnaire will not be administered at the 4 month time points. Furthermore, the 10 month time point will utilise the questionnaires related to the primary and secondary outcomes only.
An actiwatch will also be used for selected participants. An actiwatch is a wrist-like device which monitors movement above a given threshold via an accelerometer and provides data on sleep-wake patterns over a period of time [42].
Procedure
Recruitment from Royal Prince Alfred Hospital (RPAH) prenatal classes
Patients attending prenatal classes at the RPAH will be approached by the study coordinator with a brief explanation of the study and the participant information sheet. Participants will be given the opportunity to provide their contact details. The study coordinator will then make contact with these individuals to explain the study more thoroughly and screen them for eligibility.
Recruitment from Facebook.com
In order to maximise recruitment, a Facebook page was published, facilitating participants to ‘share’ or recommend the study with other potential participants as well as allowing interested individuals to access the information and volunteer themselves as participants. The link to the active Facebook page as well as a screen shot of the page and the pictures presented on the page can be found in Additional file 1: Figure S2: Facebook Page ‘Sleep for New Mums’.
Time 1
Participants will be called by the study coordinator. The study will be explained and medical history, demographics and other relevant information will be collected. If the individuals are eligible, they will be asked to provide informed consent and complete the set of baseline questionnaires.
Randomisation
Envelopes have been prepared and sealed by an independent researcher. Each enveloped is labeled ‘Cluster1’ (C1), ‘Cluster2’ (C2) etc.… Once a minimum of 3 and a maximum of 10 participants have been screened and completed the Time 1 components, they will be allocated into a cluster and an envelope will then be opened to reveal whether the participants in that cluster will receive intervention or control condition.
Time 2
Participants will receive a phone call from the study coordinator 3 weeks following the birth of the baby. For the intervention group, this is when potentially bad habits may start to form and as such we aim to remind the participants of the intervention and its content. For the control group, the phone call will be simply to provide support, which might otherwise vary between the groups.
Time 3
Six weeks after delivery, participants will be contacted by phone. The phone call will be scripted involving questions about sleep hours and patterns as well as courtesy questions about how they are managing. Participants in the intervention group will receive an additional segment of the script reminding them to look through the notes provided during the program and offering advice and support if necessary. We shall explore what has or has not been useful for them and direct them to the relevant section of their notes to review. We will also allow them to ask any questions they may have about sleep. At this stage, all participants will complete the online questionnaires once again. These questionnaires will include the baseline and post-delivery questionnaires.
Time 4
Approximately 4 months after delivery, participants will fill out the baseline and post-delivery questionnaires again.
Time 5
10 months after delivery; participants will fill out 2 questionnaires about sleep (PSQI & ISI), 2 about depression (DASS & EPDS) and the sleep and feeding questionnaires. This will conclude their participation in the study. A flowchart of the procedure can be seen in Figure 1.
The time points for data collection have been designed to follow common milestones in sleep pattern developments and changes. Time 3 (6 weeks postpartum) has been scheduled as few infants develop a consistent sleep wake pattern before this time so we will be able to explore how the mothers have managed this inconsistency as well as being able to give them guidance about what to look for over the coming weeks as the patterns do start to emerge [43]. Time 4 (4 months postpartum) has been scheduled as infants begin to develop the self-soothing abilities around 4 months of age [44] and it is at this time that the most rapid consolidation of sleep regulation occurs [45]. Therefore, completing the questionnaires at this time point will indicate changes when infants have a more predictable sleep wake pattern. Time 5 (10 months postpartum) has been scheduled for two reasons. Firstly, most infants no longer have a nutritional need for a night time feed and therefore in most instances babies should be able to sleep through the night at this stage [45]. Secondly, assessing mood at this time will ensure that the majority of participants with postnatal depression are found as most postnatal depression onset occurs by the 10th month postpartum [45, 46].
Two participants per cluster will be chosen to wear an actiwatch in order to collect actigraphy measures for 5 – 7 days at Time 1 and 5 – 7 days at Time 4. The actigraphy measure will be an objective indicator of sleep-wake patterns and a validation of their self-reported sleep patterns. The actiwatches will be posted to selected participants with a reply-paid envelope. For practical reasons, the participants in each group whose babies have the latest due date will be asked to participate in the actigraphy study.
Intervention
The intervention will consist of two 1.5hrs psychoeducational sessions held in the evenings at institutes connected to The University of Sydney. The first session, will focus on the sleep of the mother and the topics below will be outlined:
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1.
Understanding Sleep
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2.
Sleep changes during pregnancy
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3.
Adjusting to sleep disruption with parenthood
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4.
Expectations with becoming a parent
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5.
Sleep and Mood
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6.
Sleep during labour
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7.
Sleep for the first few days & weeks
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8.
Sleep and anxiety
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9.
The role of the partner
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10.
Understanding fatigue
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11.
Managing fatigue… as best you can
The second session will focus on the sleep of the baby. The topics below will be covered:
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1.
Foetal Sleep
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2.
Infant Sleep (quiet and active)
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3.
Baby monitors
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4.
How sleep needs change with age
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5.
How to know when your baby needs sleep
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6.
Basic rest & activity cycle (BRAC)
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7.
Helping your baby get to sleep & Soothing strategies
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8.
N.A.P.S. (Note time, Add 90, Play, Soothe)
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9.
Infant sleep 3 – 12 months
The sleep intervention contains videos of three new mothers with babies aged 6 weeks, 5 months and 6 months. These ‘real life’ mothers share their experiences of motherhood from their sleep & mood to how they learned to feed/settle their babies. A key message was the variation in their individual experiences of motherhood.
The program seeks to normalise sleep changes that occur during pregnancy and as a new mother. Further, it will encourage women to develop strategies to improve sleep when necessary. Specifically, information on the mechanisms of sleep and the importance of circadian rhythm and how this develops in newborns will be provided. Specific attention will be given to the difference between active and quiet sleep in newborns to ensure that new mothers do not mistake the transition between sleep stages and disrupt sleeping infants unnecessarily. Furthermore, we aim to clarify the many misconceptions associated with sleep and in particular, napping. Following the workshop, participants will have information of how to manage naps in order to improve daytime fatigue without disrupting their subsequent night of sleep.
The program aims to reassure women, that while they may get very little sleep in the first few weeks, infants will make changes in their sleep patterns as they develop. Hence, the sleep disturbance associated with motherhood will improve with time. During these early times, where sleep is necessarily compromised, the program will encourage women to sleep in preference to other activities, such as completing housework or socialising [47], when necessary.
Although the individuality of different infants will be emphasised, common infant signals for sleepiness and settling strategies will be discussed. As part of the educational component, the program describes common sleep patterns and milestones at different ages of the infant so that new mothers are prepared for the typical patterns of sleeping that characterise different stages of infancy. We also include interviews with new mothers to emphasize the key educational points raised.
The relationship between mood and sleep disturbance will be highlighted. The program will encourage women to enlist help from their partner, family and friends during this time.
The control group will receive booklets about babies’ sleep, managing sleep long term and relaxation strategies. These booklets will be given to the intervention groups as well.
Statistical considerations
Power is difficult to calculate given that only one study has attempted to intervene in sleep in the pre or postnatal period. That intervention was delivered early in the postpartum period. The authors found a large effect size on both sleep duration (ES = 1.15), and depressive symptoms using the Edinburgh Postnatal Depression Scale (ES= 0.78) [39]. It is unclear whether a preventative program would achieve such large effect sizes. However, studies in individuals with insomnia attending a sleep intervention have consistently found effect sizes in the 0.4 – 0.8 range [48, 49]. Hence, we chose the smallest of these effect sizes in order to be conservative. This was particularly important as the effect sizes we have taken into consideration were shown in interventions that treated people for insomnia, which one would expect to have a greater effect than a preventative program wherein the sample begins at a baseline level. The effect sizes (Cohen’s d) from past sleep programs using the sleep questionnaires of the current study (the PSQI and ISI) has ranged from 0.35 – 0.88 [50]. On the basis of these in order to achieve 80% power, based on the most conservative effect size, we would need only 41 participants per group to achieve significance at 0.05 level. However, the cluster design increases the sample size requirement according to the following formula: 1 + (m – 1)*ICC, where ICC is the intra-cluster correlation, (the correlation between patients’ scores within each group) and m is the average number of patients per group. We could not find any published studies, using the sleep measures and reporting ICCs. Therefore, we based our assumptions on ICCs reported for mood variables. Again, we could not find any for EPDS, however, Adams et al. (2004) [51] published 1039 ICCs from 31 studies and found the median value to be 0.01 for the HADS (interquartile range [IQR] 0 to 0.032, range 0 to 0.840). We aim for an average group size of 6, and to be conservative took the mean for the ICC of 0.42, requiring 2.6 times the number of participants. Therefore to ensure sufficient power to find differences on quality of life at an effect size of at least 0.4, we need 107 participants per group (n=214).
We anticipate that the support from the Royal Prince Alfred Hospital as well as the Facebook page that has been set up to accept anyone who expresses interest, will enable us to recruit a sample of 214 participants over 1.5years. We have aimed to be strategically conservative in calculating sample size.
Data analysis plan
There are 4 measurement time points, of which 3 are post-intervention (6 weeks, 4 month, and 10 months follow up). A linear mixed model analysis will be implemented for each factor (sleep quality and depression) at each time point. This method takes account of both fixed and random effects and is robust to account for missing data. Fixed effects will include time; (baseline, 6 week, 4 months, 10 months) and group (intervention and control). Random effects will include subjects to account for between-subject variation. Uncorrected pairwise comparisons based on estimated marginal means will evaluate the primary hypothesis of interest – that the sleep quality of the participants in the intervention group will decline less in the postpartum period than those in the control group. Comparisons of baseline measures with post treatment will be used at follow up compared with controls.