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Could listening to music during pregnancy be protective against postnatal depression and poor wellbeing post-birth? Longitudinal associations from a preliminary prospective cohort study.

ForJournal: peerBMJ Open review only

Manuscript ID bmjopen-2017-021251

Article Type: Research

Date Submitted by the Author: 19-Dec-2017

Complete List of Authors: Fancourt, Daisy; University College London Research Department of Epidemiology and Public Health, Department of Behavioural Science and Health Perkins, Rosie; Royal College of Music, Centre for Performance Science; Imperial College London, Faculty of Medicine

MENTAL HEALTH, Depression & mood disorders < PSYCHIATRY, Maternal Keywords: medicine < OBSTETRICS

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BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Could listening to music during pregnancy be protective against postnatal depression 4 5 and poor wellbeing postbirth? Longitudinal associations from a preliminary 6 7 prospective cohort study. 8

10 a,b b,c 11 Daisy Fancourt PhD and Rosie Perkins PhD * 12 13 a 14 Department of Behavioural Science and Health, University College London, London WC1E 15 7HB 16 b Faculty ofFor Medicine, peer Imperial College review London, London SW7only 2AZ 17 18 c Centre for Performance Science, Royal College of Music, London SW7 2BS 19 * Corresponding author: Dr Daisy Fancourt, 119 Torrington Place, London, WC1E 7HB, 20 21 [email protected] 22

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BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Abstract 4 Objectives: This study explored whether listening to music during pregnancy is longitudinally 5 6 associated with lower symptoms of postnatal depression and higher wellbeing in mothers postbirth. 7 8 9 Design: Prospective cohort study. 10 11 12 Participants: We analysed data from 395 new mothers aged over 18 who provided data in the third 13 trimester of pregnancy and 3 and 6 months later (03 and 46 months post birth). 14 15 16 Primary and secondaryFor outcome peer measures: Listeningreview to music was only categorised as ‘rarely; a couple of 17 18 times a week; every day <1hr; every day 12hrs; every day 35hrs; every day 5+hrs’. Postnatal 19 depression was measured using the Edinburgh Postnatal Depression Scale (EPDS), and wellbeing was 20 21 measured using the Short WarwickEdinburgh Mental Wellbeing Scale (SWEMWBS). Multivariate 22 linear regression analyses were carried out to explore the effects of listening to music during 23 24 pregnancy on depression and wellbeing post birth, adjusted for baseline mental health and potential 25 confounding variables. Sensitivity analyses stratified by baseline mental health and used inverse 26 27 probability weighting to account for differential nonresponse. 28 29 30 Results: Listening during pregnancy is associated with higher levels of wellbeing (β=0.40, SE=0.15, 31 95%CI 0.10 to 0.70) and reduced symptoms of postnatal depression (β=0.39, SE=0.19, 95%CI 0.76

32 http://bmjopen.bmj.com/ to 0.03) in the first 3 months postbirth. However, effects disappear by 46 months postbirth. These 33 34 results appear to be particularly found amongst women with lower levels of wellbeing and high levels 35 of depression at baseline and amongst those with a history of mental health conditions. 36 37 38 Conclusions: Listening to music could be recommended as a way of supporting mental health and 39

40 wellbeing in pregnant women; in particular those who demonstrate low wellbeing or symptoms of on September 25, 2021 by guest. Protected copyright. 41 PND. 42 43 44 45 46 Keywords 47 Postnatal depression, wellbeing, mental health, music, perinatal 48 49

50 51 Strengths and limitations of this study 52 • This preliminary prospective cohort study tracked a sample of women across the perinatal 53 54 period providing data at 12 week intervals. 55 56 • The data include a rich set of variables on music listening behaviours amongst participants. 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 • We adjusted for all identified confounding variables in our analyses and ran a series of 4 sensitivity analyses to test our assumptions. 5 6 • The data are not nationally representative, although there is a clear spread of participants from 7 varying socioeconomic backgrounds as well as variations in the levels of exposure and 8 9 outcome variables. 10 • As this is a cohort study and not interventional, it is not possible to confirm csausality. 11 12

13 14 Funding statement 15 The study was funded by Arts Council England Research Grants Fund, grant number 29230014 16 For peer review only 17 (Lottery). D.F. is supported by the Wellcome Trust [205407/Z/16/Z]. The study was approved by the 18 NHS REC (15/SS/016). The study team acknowledge the support of the National Institute of Health 19 20 Research Clinical Research Network (NIHR CRN). The authors would like to thank the hospitals 21 involved as Participant Identification Centres as well as Miss Sunita Sharma, Prof Aaron Williamon 22 23 and Sarah Yorke for their support with the study. 24 25 26 Competing interests statement 27 28 Both authors declare no conflict of interest. 29

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BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Introduction 4 Perinatal mental health problems affect around 20% of women at some point during the perinatal 5 6 period (1). In terms of conditions characterised by negative symptomology, postnatal depression 7 (PND) is one of the most common problems, and is a debilitating condition characterised by fatigue, 8 9 irritability, insomnia and anhedonia; symptoms which in 25% of affected women last for at least one 10 year (2). Over the last two decades, there has been significant research into the effects of PND on 11 12 mother and infant as well as attention paid to how it can be prevented or managed (3,4). However, in 13 terms of conditions relating more to the absence of positive symptomology, such as low hedonic or 14 15 eudemonic wellbeing, there has been much less research. The few studies that do exist have found 16 that negative mood,For as indicated peer by the Edinburgh review Postnatal Depression only Scale, has a correlation of 17 18 just 0.46 with positive experiences of motherhood (5). This suggests that, as in the wider population, 19 depression and wellbeing are separate constructs in the context of perinatal mental health and a 20 21 positive perinatal experience is more than simply the inversion of negative mood (6). Building on this, 22 women even without PND have been found to demonstrate impairments in emotional problems and 23 24 vitality, suggesting that even in the absence of depression mothers can have impaired wellbeing (7). In 25 light of this, a review has argued that psychological wellbeing defined as a multidimensional 26 27 construct should be an integral part of maternity care (8), and a more recent construct analysis has 28 highlighted the importance not just of identifying PND but also of identifying women with sub 29 30 optimal perinatal wellbeing and supporting them to achieve positive psychological functioning (9). 31

32 http://bmjopen.bmj.com/ In seeking to support the perinatal mental health of women, the pregnancy period has been 33 34 highlighted as critical. Prenatal mental health has repeatedly been highlighted as one of the largest 35 predictors of postnatal depression (10–12) and wellbeing (9). In particular, the third trimester of 36 37 pregnancy has been identified as an important transition period involving adaptation to emotional and 38 physical changes, leading to feelings of wellbeing often less pronounced than in the previous 39

40 trimesters (13). Early detection of symptoms of depression and low wellbeing during pregnancy and on September 25, 2021 by guest. Protected copyright. 41 prompt intervention is therefore important in reducing adverse consequences. 42 43 44 In light of this, there are a number of interventions that have been developed to try and support mental 45 46 health in the prenatal period as a way of reducing postnatal mental health problems, in particular 47 focusing on the third trimester as a point of intervention. There have been findings that support the 48 49 application of cognitivebehavioural and interpersonal psychotherapy, suggesting that depression 50 following childbirth could be prevented by brief interventions in the prenatal period (14,15). In 51 52 exploring other interventions, prenatal hypnotherapy has been found to significantly reduce PND and 53 improve psychological wellbeing at two weeks and ten weeks postpartum (16). And a psychosocial 54 55 intervention involving group meetings to discuss aspects of parenthood in the final trimester of 56 pregnancy and first 6 months postpartum has been found to reduce PND amongst firsttime mothers 57 58 4 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 (14). However, as many mothers continue to work fulltime until shortly before their due dates, in 4 person interventions may not be feasible for all mothers and are of course limited by what is available 5 6 in different geographical areas. As a result, there is a need to identify other homebased interventions 7 that could provide similar mental health support. 8 9 10 Over the past two decades, there has been increasing research showing the effects of listening to 11 12 music on mental health. A number of reviews have demonstrated the effects of regular music listening 13 including in enhancing mental health in the general population (17), reducing distress in premature 14 15 infants (18), and reducing stress in adults (19). Specifically in relation to depression, listening to 16 music has been For shown to reducepeer depression review amongst adults withonly chronic pain (20), psychiatric 17 18 inpatients (21), and older adults (17,22). In relation to wellbeing, music listening has been shown to 19 be associated with better wellbeing not just in controlled interventions but also as a result of ordinary 20 21 daytoday listening. A Swedish study involving 500 older adults found correlations between music 22 listening and wellbeing, even when controlling for potential confounding variables (23). Studies 23 24 tracking daily activities have linked music listening with enhanced wellbeing both in the workplace 25 and in the wider context of people’s lives (24,25). Further, music has also been shown to contribute to 26 27 creating supportive healthy environments, connecting individuals with their emotions and promoting 28 wellbeing (26). Finally, theoretical studies have highlighted the role of music listening in enhancing 29 30 affect, wellness and resources for recovery and quality of life (27,28). Consequently, both directed 31 music listening interventions and routine daytoday music listening can affect levels of depression

32 http://bmjopen.bmj.com/ and wellbeing amongst a range of different populations. 33 34 35 Specifically in relation to the perinatal period, a few studies have suggested that music listening may 36 37 be supportive for mental health. Listening to music for just 30 minutes has been found to reduce 38 cortisol levels and anxiety in pregnant women, leading to recommendations that pregnant women 39

40 might benefit from regular listening to music as a practice of relaxation (although the effects of on September 25, 2021 by guest. Protected copyright. 41 regular listening were not tested) (29). A recent study found that women who listened to recorded 42 43 music for 12 weeks during their pregnancy had significant improvements in anxiety and depression 44 (30). However, the study did not track outcomes postnatally and involved a small sample of women. 45 46 And a further study has found crosssectional associations between listening to music and depression 47 and wellbeing amongst new mothers (31). However, this study did not look longitudinally nor involve 48 49 pregnant women. 50 51 52 Therefore, to date, despite promising results suggesting that listening to music can modulate mental 53 health and wellbeing during the perinatal period, no studies have looked specifically at the impact of 54 55 listening to music during pregnancy on depression and wellbeing postbirth. In order to address this 56 research gap, this study tracked a cohort of mothers across the perinatal period in order to ascertain 57 58 5 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 18

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 whether there was a relationship between music listening during pregnancy and postnatal mental 4 health. 5 6 Methods 7 Participants and procedure 8 9 This study used data collected as part of a larger study exploring the impact of creative interventions 10 on perinatal mental health. Women living in England in the last trimester of pregnancy (28 weeks or 11 12 more) and the first nine months post birth (up to 40 weeks) were recruited from hospitals, General 13 Practices, mother and baby charities and through social media in England across October 2015 to 14 15 March 2016, and completed an anonymous crosssectional online questionnaire. Women in the final 16 trimester of pregnancyFor (28 peer weeks or more) review were then invited only to continue their participation in a 17 18 longitudinal study. This involved providing another wave of data 3 months, 6 months and 9 months 19 following the first date of data collection (which equated to providing baseline data T1 during 20 21 pregnancy, T2 data in the first 3 months postbirth, T3 data in months 46 postbirth and T4 data in 22 months 79 postbirth). From an initial sample of 550 mothers who consented to be involved in this 23 24 longitudinal study, a total of 458 mothers provided T2 data (83%), 417 provided T3 data (75.8%) and 25 392 (71.3%) provided T4 data. The study received ethical approval from the UK NHS Research 26 27 Ethics Service and all participants gave informed consent prior to involvement in the research. 28 29 30 For this study, we focused on women in the longitudinal study who had provided complete data on the 31 variables we selected for analyses at both T1 and T2: 395 women. We also ran some exploratory

32 http://bmjopen.bmj.com/ followup analyses with women who had also provided complete data at T3 (n=307). At T1, women 33 34 had an average age of 31.9 years (SD=4.9, range 1847) and an average of 32.9 weeks pregnant 35 (SD=4.1, range 2842). A total of 69.3% were married, 25.9% were cohabiting with a partner, a 36 37 further 3.8% were in a relationship but not living together and 1% were single. Of those in 38 relationships, 97.02% reported that their partners worked. Amongst the women, 13.2% had a basic 39

40 education (equivalent to leaving school at 16), 16.5% had finished education at 18, 41.3% had an on September 25, 2021 by guest. Protected copyright. 41 undergraduate degree and 29.1% had a postgraduate degree. Just 6.6% reported a household income 42 43 of less than £16,000, 11.1% reported an income of £16,000£30,000, 52.9% reported an income of 44 £31,000 to £60,000, 17.5% reported an income of £61,00090,000 and 11.9% reported an income of 45 46 over £91,000. 47 48 49 Measures 50 Symptoms of PND were measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10item 51 52 scale used extensively both with pregnant women and new mothers, scored from 030 with 10+ 53 indicative of possible symptoms of depression and higher scores of 13+ indicating more severe 54 55 depression (32). 56 57 58 6 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Wellbeing was measured using the Short WarwickEdinburgh Mental Wellbeing Scale 4 (SWEMWBS), a scale that encompasses both hedonic and eudemonic wellbeing comprising 7 items 5 6 scored from 7 to 35 with higher scores representing higher levels of wellbeing. The raw scores were 7 logittransformed prior to analysis (33). The New Economics Foundation (NEF) suggests five levels 8 9 of wellbeing based on quintile analyses of data in the UK Understanding Society Survey, 2009: poor 10 (<22), below average (2224), average (2526), good (2728) and excellent (2935). 11 12 13 In addition, demographic variables assessed the women’s number of weeks pregnant/postbirth, 14 15 number of other children (0, 1, 2, 3 and 4+), household income (<£16,000, £16,000£30,000, £31,000 16 £60,000, £61,000£90,000,For peer >£90,000), educational review attainment only (school to 16, sixth form/college, 17 18 undergraduate degree, postgraduate degree), marital status (married vs not married), employment 19 status (working vs not working), partner’s employment status (working vs not working) and whether 20 21 the woman had previously been diagnosed with either anxiety or depression. Finally, listening to 22 music was categorised as ‘rarely; a couple of times a week; every day <1hr; every day 12hrs; every 23 24 day 35hrs; every day 5+hrs’. 25 26 27 Statistics 28 Data were analysed using Stata v14. Multiple linear regression models were used to explore the 29 30 effects of listening to music on wellbeing and PND. Model 1 was unadjusted, while Model 2 adjusted 31 for baseline wellbeing/depression, mother’s age, maternal education status, household income and

32 http://bmjopen.bmj.com/ number of previous children, as well as how many weeks the baby was postbirth, and the mother’s 33 34 marital status at T2, whether she was working at T1 or T2, whether her partner was working at T2, 35 and previous histories of both anxiety and depression. 36 37 38 All models displayed linearity as assessed by augmented partial residual plots with lowess smoothing; 39

40 multicollinearity as assessed by checking variance inflation factors; normality as assessed using on September 25, 2021 by guest. Protected copyright. 41 kernel density plots, standardised normal probability (PP) plots and QQ plots; and there was no 42 43 evidence of outliers or undue influence as assessed using added variable plots regressing each variable 44 against all others, through stem and leaf plots, and through assessing covariance ratios, Cook’s 45 46 distance and leverage. The wellbeing regression models demonstrated homoscedasticity as assessed 47 by plotting the residuals versus fitted (predicted) values and using the BreuschPagan test for 48 49 heteroskedasticity. However, the depression regression models showed signs of heteroskedasticity, so 50 robust standard errors were calculated. 51 52 53 Planned sensitivity analyses were then conducted in order to ascertain whether listening to music was 54 55 of particular value for (i) women with above or below average wellbeing during pregnancy (using the 56 57 58 7 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 18

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 NEF cutoffs) or different levels of depression during pregnancy (using EPDS>=10 cutoff) 4 respectively; and (ii) women with or without histories of anxiety or depression. 5 6 7 In order to take account of potential demographic differences between those who provided data at Q3 8 9 and those who failed to, the propensity score for nonresponse was calculated and inverse probability 10 weighting was applied to the T3 regression models. 11 12 13 Results 14 15 Demographics. Regarding music listening habits, just 5.6% of women reported listening to music 16 ‘rarely’ in the finalFor trimester peer of pregnancy. review17.2% reported listening only just a ‘couple of times a week’. 17 18 The rest of women reported listening daily: 34.4% reported listening every day but for less than 1 19 hour; 29.9% reported listening every day for 12 hours; 8.6% reported listening every day for 35 20 21 hours; and 4.3% reported listening every day for 5 hours or more. While these analyses focused on 22 quantity of music listening as a predictor, we did record genre of music listened to. 21.0% reported 23 24 listening to jazz, 93.7% reported listening to pop music, 57.7% reported listening to rock music, 25 34.2% reported listening to classical music, 22.8% reported listening to folk music and 42.8% 26 27 reported listening to R&B. 28 29 30 The average wellbeing score at T1 was 24.1 (SD=3.9, range 11.2535), at T2 was 23.9 (SD=4.3, range 31 735) and at T3 was 23.8 (SD=4.1, range 735) (Table 1). In order to calculate the change in

32 http://bmjopen.bmj.com/ wellbeing amongst these women, we analysed the difference in scores from T1 to T2 and T1 to T3. 33 34 39.2% of mothers experienced a decrease or at least 1 point in their wellbeing from T1 to T2, while 35 30.4% experienced no change and 30.4% experienced an improvement of at least 1 point. This 36 37 equated to a strong correlation between results at T1 and T2 (r=0.63, p<.001). From T1 to T3, 41.4% 38 of mothers experienced a decrease or at least 1 point in their wellbeing, while 25.7% experienced no 39

40 change and 32.9% experienced an improvement of at least 1 point. This equated to a strong on September 25, 2021 by guest. Protected copyright. 41 correlation between results at T1 and T3 (r=0.61, p<.001). 42 43 44 Table 1: Levels of wellbeing and postnatal depression during pregnancy (T1), 0-3 months post- 45 46 birth (T2) and 4-6 months post-birth (T3). 47 T1 T2 T3 48 Wellbeing 49 Poor (<22) 29.4% 31.1% 31.6% 50 Below average (2224) 25.6% 24.1% 25.4% 51 52 Average (2526) 23.5% 21.3% 20.9% 53 Good (2728) 10.1% 11.7% 13.7% 54 Excellent (2935) 11.4% 11.9% 8.5% 55 Depression 56 EPDS<10 74.7% 72.2% 73.3% 57 58 8 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 EPDS>=10 25.3% 27.9% 26.7% 4 5 As with wellbeing, we calculated the change in symptoms of PND from T1 to T2 and T1 to T3 (table 6 7 1). 43.6% of mothers experienced an increase in the number of symptoms of PND they were 8 experiencing from T1 to T2, while 11.2% experienced no change, and 45.3% of mothers experienced 9 10 an improvement in symptoms. This equated to a strong correlation between results at T1 and T2 11 (r=0.58, p<.001). From T1 to T3, 56.4% of mothers experienced an increase in the number of 12 13 symptoms of PND they were experiencing, while 11.6% experienced no change and 43.6% 14 experienced an improvement in symptoms. This equated to a strong correlation between results at T1 15 16 and T3 (r=0.55, p<.001).For In termspeer of the interaction review between wellbeing only and symptoms of PND, there 17 was a large correlation between the two at T1 (r=0.67, p<.001), T2 (r=0.76, p<.001) and T3 (r= 18 19 0.77, p<.001). 20 21 22 Regression results: Listening to music while pregnant was associated with higher wellbeing levels 03 23 months postbirth, even when accounting for potential confounding variables (see Table 2). However, 24 25 effects were not evident 46 months postbirth. There was also an association between listening to 26 music while pregnant and symptoms of PND, even when accounting for potential confounding 27 28 29 Wellbeing Symptoms of PND 30 31

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40 on September 25, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 variables, with listening to music during pregnancy associated with lower symptoms of PND in the 48 first 3 months postbirth. As with wellbeing, these results were no longer evident by months 46 post 49 50 birth. 51 52 53 Table 2: Associations between listening to music during pregnancy on wellbeing and symptoms 54 of postnatal depression post-birth 55 56 57 58 9 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 18

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Months 0-3 post birth 4 β SE 95% CI t β SE 95% CI t 5 Model 1 0.63 0.19 0.26 – 1.00 3.38*** -0.52 0.23 -0.98 – -0.06 -2.21* 6 R2=0.03, F(1, 393)=11.44, p=.001 R2=0.01, F(1,393)=4.74, p=.03 7 Model 2 0.40 0.15 0.10 - 0.70 2.61** -0.39 0.19 -0.76 - -0.03 -2.10* 8 R2=0.43, F(18,376)=15.97, p<.001 R2=0.39, F(18,376)=9.58, p<.001 9 Months 3-6 post birth 10 β SE 95% CI t β SE 95% CI t 11 Model 1 0.32 0.22 0.11 – 0.76 1.47 0.25 0.27 0.78 – 0.28 0.93 12 R2=0.01, F(1,305)=2.17, p=.14 R2=0.003, F(1,301)=0.86, p=.35 13 Model 2 0.20 0.16 0.12 – 0.52 1.23 0.18 0.21 0.59 – 0.23 0.86 14 R2=0.44, F(18,284)=11.22, p<.001 R2=0.37, F(18,280)=7.19, p<.001 15 Model 1: unadjusted; Model 2: adjusted for baseline wellbeing/depression, mother’s age, maternal education 16 status, household incomeFor and number peer of previous review children, as well as onlyhow many weeks the baby was post-birth, 17 and the mother’s marital status at T2, whether she was working at T1 or T2 and whether her partner was working 18 at T2 and previous histories of both anxiety and depression. *p<.05, **p<.01, ***p<.001 19 20 21 22 Further analyses: Sensitivity analyses of the wellbeing regression models revealed that women with 23 poorer mental health during pregnancy had the potential to benefit most from listening to music. 24 25 Listening to music was significantly associated with wellbeing postbirth amongst women with 26 ‘below average’ and ‘poor’ levels of wellbeing (WEMWBS<25) at baseline (β=0.69, SE=0.21, 27 28 95%CI 0.29 to 1.10, p=.001) but not amongst those with ‘average’, ‘good’ or ‘excellent’ wellbeing at 29 baseline (β=0.25, SE=0.28, 95%CI 0.30 to 0.79, p=.38). Sensitivity analyses of the PND regression 30 31 models suggested similar results, with significant associations only found for women who were

32 displaying symptoms of PND at baseline (EPDS≥10) (β=1.75, SE=0.52, 95%CI 2.78 to 0.72, http://bmjopen.bmj.com/ 33 p=.001), but not for those who were not displaying symptoms (EPDS<10) (β=0.26, SE=0.24, 95%CI 34 35 0.73 to 0.21, p=.27). 36

37 38 39 Similarly, sensitivity analyses also identified that those with previous histories of anxiety or

40 on September 25, 2021 by guest. Protected copyright. 41 depression were most likely to benefit. Significant associations found for wellbeing postbirth were 42 found amongst both those who had a history of anxiety (β=1.10, SE=0.25, 95%CI 0.61 to 1.58, 43 44 p<.001) or depression (β=1.07, SE=0.26, 95%CI 0.56 to 1.58, p<.001). Similarly, significant 45 associations for symptoms of depression postbirth were found amongst both those who had a history 46 47 of anxiety (β=1.11, SE=0.36, 95%CI 1.82 to 0.41, p=.002) or depression (β=0.87, SE=0.37, 48 95%CI 1.61 to 0.13, p=.021). 49 50 51 Finally, in order to try and ascertain whether listening to music led to changes in mental health or 52 53 whether mental health led to changes in listening habits, we ran additional analyses reversing the 54 variable order. There was no evidence that levels of wellbeing during pregnancy were associated with 55 56 the likelihood of listening to music either 3 or 6 months postbirth. However, there was some 57 58 10 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 indication that depression symptoms in the final trimester of pregnancy were associated with listening 4 habits 3 months postbirth (β=0.03, SE=0.01, 95%CI 0.05 to 0.01, p=.003). 5 6 7 Discussion 8 9 This study explored associations between listening to music in the final trimester of pregnancy and 10 mental health and wellbeing in mothers postbirth. Listening was found to be associated with higher 11 12 levels of wellbeing and reduced symptoms of PND in the first 3 months postbirth, even when 13 adjusting for baseline mental health and potential confounding variables. These results appear to be 14 15 particularly found amongst women with lower levels of wellbeing at baseline. These findings echo the 16 few existing studiesFor in showing peer that listening review to music is associated only with better mental health in the 17 18 perinatal period (30,31). However, to the authors’ knowledge, this is the first study to show that 19 listening to music during pregnancy is longitudinally associated with better mental health postbirth. 20 21 22 Across both symptoms of depression and wellbeing, however, associations were only found for the 23 24 first 3 months postpartum, and had disappeared by the second quartile postpartum. The hypnosis 25 study previously described also found results within the first 3 months postpartum (weeks 2 and 10) 26 27 but did not measure beyond this, so there is little data available against which to benchmark these 28 findings (16). Nevertheless, the immediate period postbirth has been highlighted as being of 29 30 particular challenge for new mothers, with the transition into assuming maternal tasks and adjusting to 31 the new role lasting until around the third month postpartum (13,34). It is possible, therefore, that any

32 http://bmjopen.bmj.com/ effects of music listening during the prenatal period are of most value during this transition period, but 33 34 become less significant once mothers and their babies become more settled. 35

36 37 Of course, a key question is how listening to music is associated with better mental health and 38 wellbeing in the postnatal period. There are a number of potential explanations. First, studies 39

40 involving psychological tests, neuroimaging, biomarker analyses and ethnographic observations have on September 25, 2021 by guest. Protected copyright. 41 shown that listening to music can have marked effects on stress and anxiety (25). Specifically in 42 43 relation to pregnant women, listening to music for just 30 minutes can reduce cortisol levels and 44 anxiety (29). Wider studies involving listening to music have shown it to be particularly effective at 45 46 reducing psychological and physiological responses to stress, especially when people deliberately 47 listen to music in order to help them relax (35,36). This effect of music on stress has in turn been 48 49 linked specifically through to theories around wellbeing (25,37), with a wide literature linking stress 50 and anxiety with both mental health and wellbeing (38,39). It is proposed that high levels of anxiety 51 52 might hinder women’s adaptation to motherhood in the initial postpartum period, with negative 53 effects on wellbeing (40). Consequently, it is possible that the relaxing effects of listening to music 54 55 during the pregnancy period helps to act as a buffer for feelings of stress and anxiety, thereby 56 supporting mothers in maintaining their adaptation and leading to enhanced wellbeing. 57 58 11 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 18

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 4 Another potential explanation relates to the effects of music on mood. Mood regulation has been 5 6 identified as one of the prime reasons why people listen to music, with models of mood regulation by 7 music highlighting its effects on moodrelated subjective experience (including the intensity and 8 9 clarity of moods), physiological responses (such as energy levels and movement) and behaviours 10 (such as their ability to express emotions) (41). Music listening has been found to modulate 11 12 depression and wellbeing (42,43). Early low mood during the prenatal period is directly associated 13 with lower wellbeing and postnatal depression postbirth (44), leading to propositions that 14 15 interventions that deliberately attempt to cultivate positive emotions, such as relaxation therapies and 16 interventions focusedFor on finding peer positive meaning,review could directly only optimise health and wellbeing in 17 18 this population. Consequently, it is possible that another route by which listening to music in the third 19 trimester of pregnancy is associated with improvements in mental health and wellbeing is via 20 21 enhancing mood. 22 23 24 Finally, a third explanation is that listening to music in itself did not have an effect postbirth but did 25 enhance coping skills in women while they were still pregnant, which in turn led to higher wellbeing 26 27 postbirth. Music listening has been linked with both problemoriented coping and emotionoriented 28 coping, specifically with results showing that problemoriented coping by music listening in women is 29 30 linked to lower depression levels (45). Life transitions (such as the perinatal period) depend on both 31 health and wellbeing and also on appraisal and coping responses. In the hypnosis study previously

32 http://bmjopen.bmj.com/ mentioned, the authors proposed that the intervention during pregnancy helped mothers to maintain 33 34 and enhance their wellbeing whilst pregnant, which in turn influenced their appraisal of the perinatal 35 transition period and supported their coping responses (16). It is possible that a similar process took 36 37 place through listening to music, with listening to music supporting coping in the prenatal period, 38 which encouraged mothers’ own coping skills, which in turn led to better coping during and postbirth 39

40 and consequent higher wellbeing. Indeed, even just in relation to the birth, a number of birth on September 25, 2021 by guest. Protected copyright. 41 preparation courses focus on relaxation and mood optimisation, which have been shown to lead to less 42 43 negative affect and better coping during labour and delivery (46). Given that a significant predictor of 44 PND is the birth experience, enhanced coping prior to the birth, perhaps through music listening, 45 46 could be an important factor in postnatal wellbeing (47). 47 48 49 This study is limited by a few factors. First, the study followed a cohort of women rather than being 50 interventional, so it is not possible to confirm causality. However, the study had a longitudinal design, 51 52 there was no evidence of reverse causality in relation to wellbeing, there are plausible proposed 53 mechanistic explanations, and there is a strong body of previous literature causally linking music and 54 55 mental health in other populations. So this study provides promising preliminary evidence that 56 remains to be tested in a future experimental design. A second limitation is that the population in this 57 58 12 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 study was not nationally representative. Nevertheless, there was a clear spread of participants from 4 varying socioeconomic backgrounds as well as variations in the levels of exposure and outcome 5 6 variables. So the dataset provides interesting and suitable preliminary data on the longitudinal 7 associations between music listening and mental health shown here. Third, this study explored the 8 9 impact of all music listening, not specifying particular genres. Previous research has suggested that 10 certain genres of music (or more specifically compositional aspects of music such as its valence and 11 12 arousal levels) can lead to different responses, such as variations in relaxation or mood (48). 13 However, most of these genrespecific effects have been found in tightlycontrolled labbased studies, 14 15 and literature from realworld interaction with music has suggested that musical preference might be 16 more important inFor determining peer the effects ofreview music (49). This study only followed these realworld studies 17 18 in recording what genres people did listen to but measuring the quantity of listening based on 19 preference rather than genre. Future studies could explore the impact of different genres on mental 20 21 health in the perinatal period. 22 23 24 In conclusion, this study provides the first preliminary evidence that listening to music during the 25 third trimester of pregnancy could be protective against symptoms of PND and low wellbeing in the 26 27 first three months postbirth. Music listening is an attractive intervention in that it is readily available 28 to people from all echelons of society regardless of socioeconomic status, educational attainment or 29 30 cultural background. It can be carried out in a range of contexts so is not restricted to particular places 31 or times. It is also inexpensive: indeed the majority of women in the Western countries have access to

32 http://bmjopen.bmj.com/ recorded music already. Finally, there are no obvious side effects from listening to music. 33 34 Consequently, listening to music could be recommended as a way of supporting pregnant women; in 35 particular those who demonstrate low wellbeing or symptoms of PND. 36 37 38 Authors’ contributions 39

40 DF and RP designed the study and collected data. DF ran the analyses and drafted the paper. Both on September 25, 2021 by guest. Protected copyright. 41 authors critically revised the manuscript and approved it for submission. 42 43 44 45 46

47 48 49 50 51 52 53 54 55 56 57 58 13 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 18

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 References 4 1. Khalifeh H, Brauer R, Toulmin H, Howard LM. Perinatal mental health: What every 5 neonatologist should know. Early Hum Dev. 2015 Nov 1;91(11):649–53. 6 2. Morrell C, Warner R, Slade P, Dixon S, Walters S, Paley G, et al. Psychological 7 interventions for postnatal depression: cluster randomised trial and economic 8 evaluation. The PoNDER trial. Health Technol Assess [Internet]. 2009 Jun [cited 2016 9 Jul 26];13(30). Available from: http://www.journalslibrary.nihr.ac.uk/hta/volume 10 13/issue30 11 3. Cooper PJ, Murray L. Postnatal depression. BMJ. 1998 Jun 20;316(7148):1884–6. 12 4. Junge C, GarthusNiegel S, Slinning K, Polte C, Simonsen TB, EberhardGran M. The 13 Impact of Perinatal Depression on Children’s SocialEmotional Development: A 14 Longitudinal Study. Matern Child Health J. 2017 Mar 1;21(3):607–15. 15 5. Green JM, Kafetsios K. Positive experiences of early motherhood: Predictive variables 16 from a longitudinalFor study. peer J Reprod review Infant Psychol. 1997 only May 1;15(2):141–57. 17 6. Keyes CL. Mental Illness and/or Mental Health? Investigating Axioms of the Complete 18 State Model of Health. J Consult Clin Psychol. 2005;73(3):539–48. 19 7. Boyce PM, Johnstone SJ, Hickey AR, MorrisYates AD, Harris MG, Strachan T. 20 Functioning and wellbeing at 24 weeks postpartum of women with postnatal 21 depression. Arch Womens Ment Health. 2000 Dec 11;3(3):91–7. 22 8. Jomeen J. The importance of assessing psychological status during pregnancy, 23 childbirth and the postnatal period as a multidimensional construct: A literature review. 24 Clin Eff Nurs. 2004 Sep;8(3–4):143–55. 25 9. Allan C, CarrickSen D, Martin CR. What is perinatal wellbeing? A concept analysis 26 and review of the literature: J Reprod Infant Psychol [Internet]. 2013 [cited 2017 Jun 27 8];31(4). Available from: 28 http://www.tandfonline.com/doi/abs/10.1080/02646838.2013.791920 29 10. Beck CT. Predictors of postpartum depression: an update. Nurs Res. 2001 30 Oct;50(5):275–85. 31 11. Milgrom J, Gemmill AW, Bilszta JL, Hayes B, Barnett B, Brooks J, et al. Antenatal risk

32 factors for postnatal depression: a large prospective study. J Affect Disord. 2008 http://bmjopen.bmj.com/ 33 May;108(1–2):147–57. 34 12. Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum 35 depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul;26(4):289– 36 95. 37 13. Leifer M. Psychological effects of motherhood : a study of first pregnancy / Myra Leifer. 38 New York: Praeger; 1980. 39 14. Elliott SA, Leverton TJ, Sanjack M, Turner H, Cowmeadow P, Hopkins J, et al.

40 Promoting mental health after childbirth: a controlled trial of primary prevention of on September 25, 2021 by guest. Protected copyright. 41 postnatal depression. Br J Clin Psychol. 2000 Sep;39 ( Pt 3):223–41. 42 15. Spinelli MG. Prevention of postpartum mood disorders. In: Postpartum mood disorders. 43 Arlington, VA, US: American Psychiatric Association; 1999. p. 217–35. 44 16. Guse T, Wissing M, Hartman W. The effect of a prenatal hypnotherapeutic programme 45 on postnatal maternal psychological well‐being. J Reprod Infant Psychol. 2006 46 May;24(2):163–77. 47 17. Chan MF, Wong ZY, Thayala NV. The effectiveness of music listening in reducing 48 depressive symptoms in adults: A systematic review. Complement Ther Med. 2011 Dec 49 1;19(6):332–48. 50 18. Cassidy JW, Standley JM. The Effect of Music Listening on Physiological Responses of 51 Premature Infants in the NICU. J Music Ther. 1995 Dec 21;32(4):208–27. 52 19. Pelletier CL. The effect of music on decreasing arousal due to stress: a metaanalysis. 53 J Music Ther. 2004 Fall;41(3):192–214. 54 20. Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv 55 Nurs. 2006 Jun 1;54(5):553–62. 56 57 58 14 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 18 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 21. Hsu WC, Lai HL. Effects of music on major depression in psychiatric inpatients. Arch 4 Psychiatr Nurs. 2004 Oct 1;18(5):193–9. 5 22. Chan MF, Chan EA, Mok E, Kwan Tse FY. Effect of music on depression levels and 6 physiological responses in communitybased older adults. Int J Ment Health Nurs. 2009 7 Aug 1;18(4):285–94. 8 23. Laukka P. Uses of music and psychological wellbeing among the elderly. J Happiness 9 Stud. 2007 Jun 1;8(2):215. 10 24. Haake AB. Individual music listening in workplace settings An exploratory survey of 11 offices in the UK. Music Sci. 2011 Mar 1;15(1):107–29. 12 25. Vastfjall D, Juslin PN, Hartig T. Music, subjective wellbeing, and health: the role of 13 everyday emotions. In: MacDonald R, Kreutz G, Mitchell L, editors. Music, Health, and 14 Wellbeing. Oxford University Press; 2013. 15 26. McCaffrey R. Music Listening: Its Effects in Creating a Healing Environment. J 16 PsychosocFor Nurs Ment peer Health Serv. review 2008 Oct 1;46(10):39–44. only 17 27. BattRawden KB, DeNora T, Ruud E. Music Listening and Empowerment in Health 18 Promotion: A Study of the Role and Significance of Music in Everyday Life of the Long 19 term Ill. Nord J Music Ther. 2005 Jul 1;14(2):120–36. 20 28. Skånland MS. Everyday music listening and affect regulation: The role of MP3 players. 21 Int J Qual Stud Health WellBeing [Internet]. 2013 [cited 2017 Jun 14];8. Available from: 22 /pmcc/articles/PMC3740499/?report=abstract 23 29. Ventura T, Gomes MC, Carreira T. Cortisol and anxiety response to a relaxing 24 intervention on pregnant women awaiting amniocentesis. Psychoneuroendocrinology. 25 2012 Jan;37(1):148–56. 26 30. Nwebube C, Glover V, Stewart L. Prenatal listening to songs composed for pregnancy 27 and symptoms of anxiety and depression: a pilot study. BMC Complement Altern Med. 28 2017 May 8;17(1):256. 29 31. Fancourt D, Perkins R. Associations between singing to babies and symptoms of 30 postnatal depression, wellbeing, selfesteem and motherinfant bond. Public Health. 31 2017 Apr 1;145:149–52. 32. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of 32 http://bmjopen.bmj.com/ the 10item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun 33 1;150(6):782–6. 34 33. StewartBrown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal 35 construct validity of the WarwickEdinburgh Mental Wellbeing Scale (WEMWBS): a 36 Rasch analysis using data from the Scottish Health Education Population Survey. 37 Health Qual Life Outcomes. 2009;7:15. 38 34. Pridham KF, Chang AS. Transition to being the mother of a new infant in the first 3 39 months: maternal problem solving and selfappraisals. J Adv Nurs. 1992

40 on September 25, 2021 by guest. Protected copyright. Feb;17(2):204–16. 41 35. Krout RE. The effects of singlesession music therapy interventions on the observed 42 and selfreported levels of pain control, physical comfort, and relaxation of hospice 43 patients. Am J Hosp Palliat Med. 2001 Dec;18(6):383–90. 44 36. Linnemann A, Strahler J, Nater UM. The stressreducing effect of music listening varies 45 depending on the social context. Psychoneuroendocrinology. 2016 Oct 1;72:97–105. 46 37. Krout RE. Music listening to facilitate relaxation and promote wellness: Integrated 47 aspects of our neurophysiological responses to music. Arts Psychother. 48 2007;34(2):134–41. 49 38. Iwata M, Ota KT, Duman RS. The inflammasome: pathways linking psychological 50 stress, depression, and systemic illnesses. Brain Behav Immun. 2013 Jul;31:105–14. 51 39. Vedhara K, Miles J, Bennett P, Plummer S, Tallon D, Brooks E, et al. An investigation 52 into the relationship between salivary cortisol, stress, anxiety and depression. Biol 53 Psychol. 2003 Feb;62(2):89–96. 54 40. Pond E, Kemp V. A comparison between adolescent and adult women on prenatal 55 anxiety and selfconfidence. Matern Child Nurs J. 1992;20(1):11–20. 56 57 58 15 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 18

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 41. Saarikallio S, Erkkilä J. The role of music in adolescents’ mood regulation. Psychol 4 Music. 2007 Jan 1;35(1):88–109. 5 42. Chin T, Rickard NS. Emotion regulation strategy mediates both positive and negative 6 relationships between music uses and wellbeing. Psychol Music. 2014 Sep 7 1;42(5):692–713. 8 43. Lai YM. Effects of Music Listening on Depressed Women in Taiwan. Issues Ment 9 Health Nurs. 1999 Jan 1;20(3):229–46. 10 44. Fleming A, N. Ruble D, L. Flett G, L. Shaul D. Postpartum Adjustment in FirstTime 11 Mothers: Relations Between Mood, Maternal Attitudes, and MotherInfant Interactions. 12 Dev Psychol. 1988 Jan 1;24:71–81. 13 45. Miranda D, Claes M. Music listening, coping, peer affiliation and depression in 14 adolescence. Psychol Music. 2009 Apr 1;37(2):215–33. 15 46. Duncan S, J. Markman H. Intervention programs for the transition to parenthood: 16 Current statusFor from apeer prevention perspective. review 2017 Oct only 26; 17 47. Green JM. Expectations and experiences of pain in labor: findings from a large 18 prospective study. Birth Berkeley Calif. 1993 Jun;20(2):65–72. 19 48. Labbe E, Schmidt N, Babin J, Pharr M. Coping with stress: the effectiveness of different 20 types of music. Appl Psychophysiol Biofeedback. 2007 Dec;32(3–4):163–8. 21 49. Fancourt D, Ockelford A, Belai A. The psychoneuroimmunological effects of music: A 22 systematic review and a new model. Brain Behav Immun. 2014 Feb;36:15–26. 23 24 25 26 27 28 29 30 31

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40 on September 25, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 16 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 18 BMJ Open

1 STROBE Statement—Checklist of items that should be included in reports of cohort studies 2 3 Item No 4 Recommendation Page BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 5 Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the 1 6 7 abstract 8 (b) Provide in the abstract an informative and balanced summary of what was 2 9 done and what was found 10 11 Introduction 12 Background/rationale 2 Explain the scientific background and rationale for the investigation being 4-5 13 reported 14 Objectives 3 State specific objectives, including any prespecified hypotheses 5 15 16 Methods 17 Study design 4 Present key elements of study design early in the paper 6 18 For peer review only Setting 5 Describe the setting, locations, and relevant dates, including periods of 6 19 20 recruitment, exposure, follow-up, and data collection 21 Participants 6 (a) Give the eligibility criteria, and the sources and methods of selection of 6 22 participants. Describe methods of follow-up 23 24 (b) For matched studies, give matching criteria and number of exposed and 25 unexposed 26 Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and 6-7 27 effect modifiers. Give diagnostic criteria, if applicable 28 29 Data sources/ 8* For each variable of interest, give sources of data and details of methods of 6-7 30 measurement assessment (measurement). Describe comparability of assessment methods if 31 there is more than one group 32 Bias 9 Describe any efforts to address potential sources of bias 7-8 33 34 Study size 10 Explain how the study size was arrived at 35 Quantitative 11 Explain how quantitative variables were handled in the analyses. If applicable, 6-7

36 variables describe which groupings were chosen and why http://bmjopen.bmj.com/ 37 38 Statistical methods 12 (a) Describe all statistical methods, including those used to control for 7 39 confounding 40 (b) Describe any methods used to examine subgroups and interactions 7-8 41 (c) Explain how missing data were addressed 8 42 43 (d) If applicable, explain how loss to follow-up was addressed 8

44 (e) Describe any sensitivity analyses 7-8 on September 25, 2021 by guest. Protected copyright. 45 46 Results 47 Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers 6 48 potentially eligible, examined for eligibility, confirmed eligible, included in the 49 study, completing follow-up, and analysed 50 51 (b) Give reasons for non-participation at each stage 52 (c) Consider use of a flow diagram 53 Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) 6 54 and information on exposures and potential confounders 55 56 (b) Indicate number of participants with missing data for each variable of N/A 57 interest 58 (c) Summarise follow-up time (eg, average and total amount) 6 59 60 Outcome data 15* Report numbers of outcome events or summary measures over time 8-9 Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates 8-9 and their precision (eg, 95% confidence interval). Make clear which 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 18 of 18

1 confounders were adjusted for and why they were included 2 (b) Report category boundaries when continuous variables were categorized 3

4 (c) If relevant, consider translating estimates of relative risk into absolute risk BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 5 for a meaningful time period 6 Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and 9-10 7 sensitivity analyses 8 9 Discussion 10 Key results 18 Summarise key results with reference to study objectives 10 11 12 Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or 12 13 imprecision. Discuss both direction and magnitude of any potential bias 14 Interpretation 20 Give a cautious overall interpretation of results considering objectives, 12 15 limitations, multiplicity of analyses, results from similar studies, and other 16 17 relevant evidence 18 Generalisability 21For Discuss peer the generalisability review (external validity) only of the study results 12 19 Other information 20 21 Funding 22 Give the source of funding and the role of the funders for the present study and, 3 22 if applicable, for the original study on which the present article is based 23 24 *Give information separately for exposed and unexposed groups. 25 26 27 Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and 28 published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely 29 available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at 30 31 http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is 32 available at http://www.strobe-statement.org. 33 34 35

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44 on September 25, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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Could listening to music during pregnancy be protective against postnatal depression and poor wellbeing post-birth? Longitudinal associations from a preliminary prospective cohort study.

ForJournal: peerBMJ Open review only

Manuscript ID bmjopen-2017-021251.R1

Article Type: Research

Date Submitted by the Author: 16-Mar-2018

Primary Subject Mental health Heading:

Secondary Subject Heading: Obstetrics and gynaecology

MENTAL HEALTH, Depression & mood disorders < PSYCHIATRY, Maternal http://bmjopen.bmj.com/ Keywords: medicine < OBSTETRICS

on September 25, 2021 by guest. Protected copyright.

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BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Abstract 4 Objectives: This study explored whether listening to music during pregnancy is longitudinally 5 6 associated with lower symptoms of postnatal depression and higher wellbeing in mothers postbirth. 7 8 9 Design: Prospective cohort study. 10 11 12 Participants: We analysed data from 395 new mothers aged over 18 who provided data in the third 13 trimester of pregnancy and 3 and 6 months later (03 and 46 months post birth). 14 15 16 Primary and secondaryFor outcome peer measures: reviewPostnatal depression onlywas measured using the Edinburgh 17 18 Postnatal Depression Scale (EPDS), and wellbeing was measured using the Short WarwickEdinburgh 19 Mental Wellbeing Scale (SWEMWBS). Our exposure was listening to music and was categorised as 20 21 ‘rarely; a couple of times a week; every day <1hr; every day 12hrs; every day 35hrs; every day 22 5+hrs’. Multivariable linear regression analyses were carried out to explore the effects of listening to 23 24 music during pregnancy on depression and wellbeing post birth, adjusted for baseline mental health 25 and potential confounding variables. 26 27 28 Results: Listening during pregnancy is associated with higher levels of wellbeing (β=0.40, SE=0.15, 29 30 95%CI 0.10 to 0.70) and reduced symptoms of postnatal depression (β=0.39, SE=0.19, 95%CI 0.76 31 to 0.03) in the first 3 months postbirth. However, effects disappear by 46 months postbirth. These

32 http://bmjopen.bmj.com/ results appear to be particularly found amongst women with lower levels of wellbeing and high levels 33 34 of depression at baseline. 35

36 37 Conclusions: Listening to music could be recommended as a way of supporting mental health and 38 wellbeing in pregnant women; in particular those who demonstrate low wellbeing or symptoms of 39

40 postnatal depression. on September 25, 2021 by guest. Protected copyright. 41

42 43 44 Keywords 45 46 Postnatal depression, wellbeing, mental health, music, perinatal 47 48 49 Strengths and limitations of this study 50 51 • This preliminary prospective cohort study tracked a sample of women across the perinatal 52 period providing data at 12 week intervals. 53 54 • The data include a rich set of variables on music listening behaviours amongst participants. 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 19 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 • We adjusted for all identified confounding variables in our analyses and ran sensitivity 4 analyses to test our assumptions. 5 6 • The data are not nationally representative, although there is a clear spread of participants from 7 varying socioeconomic backgrounds as well as variations in the levels of exposure and 8 9 outcome variables. 10 • As this is a cohort study and not interventional, it is not possible to confirm causality. 11 12

30 31

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BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Introduction 4 Perinatal mental health problems affect around 20% of women at some point during the perinatal 5 6 period (1). In terms of conditions characterised by negative symptomology, postnatal depression 7 (PND) is one of the most common problems, and is a debilitating condition with symptoms including 8 9 fatigue, irritability, insomnia and anhedonia; symptoms which in 25% of affected women last for at 10 least one year (2). Over the last two decades, there has been significant research into the effects of 11 12 PND on mother and infant as well as attention paid to how it can be prevented or managed (3,4). 13 However, in terms of conditions relating more to the absence of positive symptomology, such as low 14 15 hedonic or eudemonic wellbeing, there has been much less research. The few studies that do exist 16 have found that negativeFor mood, peer as indicated review by the Edinburgh Postnatalonly Depression Scale (EPDS), 17 18 has a correlation of just 0.46 with positive experiences of motherhood, as indicated by a principal 19 component analysis of six experiences of motherhood (POSMO) (5). This suggests that, as in the 20 21 wider population, depression and wellbeing are separate constructs in the context of perinatal mental 22 health and a positive perinatal experience is more than simply the inversion of negative mood (6). 23 24 Building on this, women even without PND have been found to demonstrate impairments in 25 emotional problems and vitality, suggesting that even in the absence of depression mothers can have 26 27 impaired wellbeing (7). In light of this, a review has argued that psychological wellbeing defined as a 28 multidimensional construct should be an integral part of maternity care (8), and a more recent 29 30 construct analysis has highlighted the importance not just of identifying PND but also of identifying 31 women with suboptimal perinatal wellbeing and supporting them to achieve positive psychological

32 http://bmjopen.bmj.com/ functioning (9). 33 34 35 In seeking to support the perinatal mental health of women, the pregnancy period has been 36 37 highlighted as critical. Prenatal mental health has repeatedly been shown to be one of the largest 38 predictors of postnatal depression (10–12) and wellbeing (9). In particular, the third trimester of 39

40 pregnancy has been identified as an important transition period involving adaptation to emotional and on September 25, 2021 by guest. Protected copyright. 41 physical changes, leading to feelings of wellbeing often less pronounced than in the previous 42 43 trimesters (13). Early detection of symptoms of depression and low wellbeing during pregnancy and 44 prompt intervention is therefore important in reducing adverse consequences. 45 46 47 In light of this, there are a number of interventions that have been developed to try and support mental 48 49 health in the prenatal period as a way of reducing postnatal mental health problems, in particular 50 focusing on the third trimester as a point of intervention. There have been findings that support the 51 52 application of cognitivebehavioural and interpersonal psychotherapy, suggesting that depression 53 following childbirth could be prevented by brief interventions in the prenatal period (14,15). In 54 55 exploring other interventions, prenatal hypnotherapy has been found to significantly reduce PND and 56 improve psychological wellbeing at two weeks and ten weeks postpartum (16). And a psychosocial 57 58 4 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 19 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 intervention involving group meetings to discuss aspects of parenthood in the final trimester of 4 pregnancy and first 6 months postpartum has been found to reduce PND amongst firsttime mothers 5 6 (14). However, as many mothers continue to work fulltime until shortly before their due dates, in 7 person interventions may not be feasible for all mothers and are of course limited by what is available 8 9 in different geographical areas. As a result, there is a need to identify other homebased interventions 10 that could provide similar mental health support. 11 12 13 Over the past two decades, there has been increasing research showing the effects of listening to 14 15 music on mental health. A number of reviews have demonstrated the effects of regular music listening 16 including in enhancingFor mental peer health in the review general population (17),only reducing distress in premature 17 18 infants (18), and reducing stress in adults (19). Specifically in relation to depression, listening to 19 music has been shown to reduce depression amongst adults with chronic pain (20), psychiatric 20 21 inpatients (21), and older adults (17,22). In relation to wellbeing, music listening has been shown to 22 be associated with better wellbeing not just in controlled interventions but also as a result of ordinary 23 24 daytoday listening. A Swedish study involving 500 older adults found associations between music 25 listening and wellbeing, even when controlling for potential confounding variables (23). Studies 26 27 tracking daily activities have linked music listening with enhanced wellbeing both in the workplace 28 and in the wider context of people’s lives (24,25). Further, music has also been shown to contribute to 29 30 creating supportive healthy environments, connecting individuals with their emotions and promoting 31 wellbeing (26). Finally, theoretical studies have highlighted the role of music listening in enhancing

32 http://bmjopen.bmj.com/ affect, wellness and resources for recovery and quality of life (27,28). Consequently, both directed 33 34 music listening interventions and routine daytoday music listening can affect levels of depression 35 and wellbeing in a range of different populations. 36 37 38 Specifically in relation to the perinatal period, a few studies have suggested that music listening may 39

40 be supportive for mental health. Listening to music for just 30 minutes has been found to reduce on September 25, 2021 by guest. Protected copyright. 41 cortisol levels and anxiety in pregnant women, leading to recommendations that pregnant women 42 43 might benefit from regular listening to music as a practice of relaxation (although the effects of 44 regular listening were not tested) (29). A recent study found that women who listened to recorded 45 46 music for 20 minutes a day for 12 weeks during their pregnancy had significant improvements in 47 anxiety and depression (30). However, the study did not track outcomes postnatally and involved a 48 49 small sample of women. And a further study has found crosssectional associations between listening 50 to music and depression and wellbeing amongst new mothers, with more frequent listening associated 51 52 with better mental health (31). However, this study did not look longitudinally nor involve pregnant 53 women. 54 55 56 57 58 5 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 19

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Therefore, to date, despite promising results suggesting that listening to music can modulate mental 4 health and wellbeing during the perinatal period, no studies have looked specifically at the impact of 5 6 listening to music during pregnancy on depression and wellbeing postbirth. In order to address this 7 research gap, this study tracked a cohort of mothers across the perinatal period in order to ascertain 8 9 whether there was a relationship between music listening during pregnancy and postnatal mental 10 health. 11 12 13 Methods 14 15 Participants and procedure 16 This study used dataFor collected peer as part of a largerreview study exploring only the impact of creative interventions 17 18 on perinatal mental health. Women living in England in the last trimester of pregnancy (28 weeks or 19 more) and the first nine months post birth (up to 40 weeks) were recruited from hospitals, General 20 21 Practices, mother and baby charities and through social media in England across October 2015 to 22 March 2016, and completed an anonymous crosssectional online questionnaire. Women in the final 23 24 trimester of pregnancy (28 weeks or more) were then invited to continue their participation in a 25 longitudinal study. This involved providing another wave of data 3 months, 6 months and 9 months 26 27 following the first date of data collection (which equated to providing baseline data T1 during 28 pregnancy, T2 data in the first 3 months postbirth, T3 data in months 46 postbirth and T4 data in 29 30 months 79 postbirth). From an initial sample of 550 mothers who consented to be involved in this 31 longitudinal study, a total of 458 mothers provided T2 data (83%), 417 provided T3 data (75.8%) and

32 http://bmjopen.bmj.com/ 392 (71.3%) provided T4 data. The study received ethical approval from the UK NHS Research 33 34 Ethics Service and all participants gave informed consent prior to involvement in the research. 35

36 37 For this study, and in light of the literature review presented above, we hypothesised that listening 38 during pregnancy would support wellbeing and reduce symptoms of PND in the first trimester post 39

40 birth. We therefore focused on women in the longitudinal study who had provided complete data on on September 25, 2021 by guest. Protected copyright. 41 the variables we selected for analyses at both T1 and T2: 395 women. However, we also ran some 42 43 exploratory followup analyses with women who had also provided complete data at T3 (n=307) in 44 order to explore if effects were maintained. 45 46 47 Measures 48 49 Symptoms of PND were measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10item 50 scale used extensively both with pregnant women and new mothers, scored from 030 with 10+ 51 52 indicative of possible symptoms of depression and higher scores of 13+ indicating more severe 53 depression (32). 54 55 56 57 58 6 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 19 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Wellbeing was measured using the Short WarwickEdinburgh Mental Wellbeing Scale 4 (SWEMWBS), a scale that encompasses both hedonic and eudemonic wellbeing comprising 7 items 5 6 scored from 7 to 35 with higher scores representing higher levels of wellbeing. The raw scores were 7 logittransformed prior to analysis (33). The New Economics Foundation (NEF) suggests five levels 8 9 of wellbeing based on quintile analyses of data in the UK Understanding Society Survey, 2009: poor 10 (<22), below average (2224), average (2526), good (2728) and excellent (2935). 11 12 13 In addition, demographic variables assessed the women’s number of weeks pregnant/postbirth, 14 15 number of other children (0, 1, 2, 3 and 4+), household income (<£16,000, £16,000£30,000, £31,000 16 £60,000, £61,000£90,000,For peer >£90,000), educational review attainment only (school to 16, sixth form/college, 17 18 undergraduate degree, postgraduate degree), marital status (married vs not married), employment 19 status (working vs not working), partner’s employment status (working vs not working) and whether 20 21 the woman had previously been diagnosed with either anxiety or depression. 22 23 24 Listening to music was categorised as ‘rarely; a couple of times a week; every day <1hr; every day 1 25 2hrs; every day 35hrs; every day 5+hrs’. 26 27 28 Statistics 29 30 Data were analysed using Stata v14. Multivariable linear regression models were used to explore the 31 effects of listening to music on wellbeing and PND. Frequency of listening to music had a normal

32 http://bmjopen.bmj.com/ distribution so was treated as a 6point linear variable, with higher score indicating more frequent 33 34 listening. For wellbeing and PND, we used raw scores. Model 1 was unadjusted, while Model 2 35 adjusted for baseline wellbeing/depression, mother’s age, maternal education status, household 36 37 income and number of previous children, as well as how many weeks the baby was postbirth, and the 38 mother’s marital status at T2, whether she was working at T1 or T2, whether her partner was working 39

40 at T2, and previous histories of both anxiety and depression. on September 25, 2021 by guest. Protected copyright. 41

42 43 All models displayed linearity as assessed by augmented partial residual plots with lowess smoothing; 44 multicollinearity as assessed by checking variance inflation factors; normality as assessed using 45 46 kernel density plots, standardised normal probability (PP) plots and QQ plots; and there was no 47 evidence of outliers or undue influence as assessed using added variable plots regressing each variable 48 49 against all others, through stem and leaf plots, and through assessing covariance ratios, Cook’s 50 distance and leverage. The wellbeing regression models demonstrated homoscedasticity as assessed 51 52 by plotting the residuals versus fitted (predicted) values and using the BreuschPagan test for 53 heteroskedasticity. However, the depression regression models showed signs of heteroskedasticity, so 54 55 robust standard errors were calculated. 56 57 58 7 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 19

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Planned sensitivity analyses were then conducted in order to ascertain whether baseline mental health 4 during pregnancy was a moderator of the association between listening to music and mental health 5 6 post birth. For this, we included an interaction term of Q1 mental health and Q1 listening habits in our 7 regression models and then plotted twoway contour graphs to visualise the interaction (see 8 9 Supplementary Figure 1). 10 11 12 Although there were no significant demographic differences between those who did and did not 13 provide data at Q3, we wanted to take account of potential minor demographic differences between 14 15 those who provided data at Q3 and those who failed to. So the propensity score for nonresponse was 16 calculated using For the indicators peer listed in Modelreview 2 above (none only of which significantly predicted 17 18 missingness) and inverse probability weighting was applied to the T3 regression models. We 19 confirmed goodness of fit using the HosmerLemeshow test. Weighted analyses did not differ from 20 21 unweighted analyses. 22 23 24 Results 25 Demographics. At T1, women had an average age of 31.9 years (SD=4.9, range 1847) and an 26 27 average of 32.9 weeks pregnant (SD=4.1, range 2842). A total of 69.3% were married, 25.9% were 28 cohabiting with a partner, a further 3.8% were in a relationship but not living together and 1% were 29 30 single. Of those in relationships, 97.02% reported that their partners worked. Amongst the women, 31 13.2% had a basic education (equivalent to leaving school at 16), 16.5% had finished education at 18,

32 http://bmjopen.bmj.com/ 41.3% had an undergraduate degree and 29.1% had a postgraduate degree. Just 6.6% reported a 33 34 household income of less than £16,000, 11.1% reported an income of £16,000£30,000, 52.9% 35 reported an income of £31,000 to £60,000, 17.5% reported an income of £61,00090,000 and 11.9% 36 37 reported an income of over £91,000. 38

40 Regarding music listening habits, just 5.6% of women reported listening to music ‘rarely’ in the final on September 25, 2021 by guest. Protected copyright. 41 trimester of pregnancy. 17.2% reported listening just a ‘couple of times a week’. The rest of women 42 43 reported listening daily: 34.4% reported listening every day but for less than 1 hour; 29.9% reported 44 listening every day for 12 hours; 8.6% reported listening every day for 35 hours; and 4.3% reported 45 46 listening every day for 5 hours or more. While these analyses focused on quantity of music listening 47 as a predictor, we did record genre of music listened to. 21.0% reported listening to jazz, 93.7% 48 49 reported listening to pop music, 57.7% reported listening to rock music, 34.2% reported listening to 50 classical music, 22.8% reported listening to folk music and 42.8% reported listening to R&B. 51 52 53 The average wellbeing score at T1 was 24.1 (SD=3.9, range 11.2535), at T2 was 23.9 (SD=4.3, range 54 55 735) and at T3 was 23.8 (SD=4.1, range 735) (Table 1). In order to calculate the change in 56 wellbeing amongst these women, we analysed the difference in scores from T1 to T2 and T1 to T3. 57 58 8 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 19 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 39.2% of mothers experienced a decrease or at least 1 point in their wellbeing from T1 to T2, while 4 30.4% experienced no change and 30.4% experienced an improvement of at least 1 point. From T1 to 5 6 T3, 41.4% of mothers experienced a decrease or at least 1 point in their wellbeing, while 25.7% 7 experienced no change and 32.9% experienced an improvement of at least 1 point. 8 9 10 Table 1: Levels of wellbeing and postnatal depression during pregnancy (T1), 0-3 months post- 11 12 birth (T2) and 4-6 months post-birth (T3). 13 T1 T2 T3 14 Wellbeing 15 Poor (<22) 29.4% 31.1% 31.6% 16 For Below peer average (22 review24) 25.6% 24.1% only 25.4% 17 Average (2526) 23.5% 21.3% 20.9% 18 Good (2728) 10.1% 11.7% 13.7% 19 Excellent (2935) 11.4% 11.9% 8.5% 20 Depression 21 EPDS<10 74.7% 72.2% 73.3% 22 EPDS>=10 25.3% 27.9% 26.7% 23 24 25 As with wellbeing, we calculated the change in symptoms of PND from T1 to T2 and T1 to T3 (table 26 1). 43.6% of mothers experienced an increase in the number of symptoms of PND they were 27 28 experiencing from T1 to T2, while 11.2% experienced no change, and 45.3% of mothers experienced 29 an improvement in symptoms. From T1 to T3, 56.4% of mothers experienced an increase in the 30 31 number of symptoms of PND they were experiencing, while 11.6% experienced no change and 43.6%

32 http://bmjopen.bmj.com/ experienced an improvement in symptoms. In terms of the interaction between wellbeing and 33 34 symptoms of PND, there was a large correlation between the two at T1 (r=0.67, p<.001), T2 (r= 35 0.76, p<.001) and T3 (r=0.77, p<.001). 36 37 38 Regression results: Listening to music while pregnant was associated with higher raw wellbeing 39

40 scores 03 months postbirth, even when accounting for potential confounding variables, with greater on September 25, 2021 by guest. Protected copyright. 41 frequency associated with greater effects (B=0.40, SE=0.15, 95%CI 0.10 to 0.70) (see Table 2). 42 43 However, our exploratory analyses showed that effects were not evident 46 months postbirth. There 44 was also an association between listening to music while pregnant and raw scores of symptoms of 45 46 PND, even when accounting for potential confounding variables, with more frequent listening to 47 music during pregnancy associated with lower symptoms of PND in the first 3 months postbirth (B= 48 49 0.39, SE=0.19, 95%CI 0.76 to 0.03). As with wellbeing, these results were no longer evident by 50 months 46 postbirth. 51 52 Table 2: Associations between listening to music during pregnancy on wellbeing and symptoms 53 of postnatal depression post-birth 54 55 56 57 58 9 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 19

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Further analyses: Sensitivity analyses of the wellbeing regression models explored the potential 4 moderating effect of mental health during pregnancy. Our analyses showed there was a significant 5 6 interaction between listening and baseline wellbeing (B=0.10 SE=0.04, 95%CI 0.17 to 0.02), with a 7 twoway contour graph showing that listening to music particularly seemed to support those with 8 9 lower wellbeing at baseline (see Supplementary Figure 1A). There was also a significant interaction 10 11 Wellbeing Symptoms of PND 12 Months 0-3 post birth 13 B SE 95% CI t B SE 95% CI t 14 Model 1 0.63 0.19 0.26 – 1.00 3.38*** -0.52 0.23 -0.98 – -0.06 -2.21* 15 2 2 16 R =0.03, F(1, 393)=11.44, p=.001 R =0.01, F(1,393)=4.74, p=.03 Model 2 0.40 For 0.15 peer 0.10 - 0.70 review 2.61** -0.39 only 0.19 -0.76 - -0.03 -2.10* 17 2 2 18 R =0.43, F(18,376)=15.97, p<.001 R =0.39, F(18,376)=9.58, p<.001 19 Months 3-6 post birth 20 B SE 95% CI t B SE 95% CI t 21 Model 1 0.32 0.22 0.11 – 0.76 1.47 0.25 0.27 0.78 – 0.28 0.93 2 2 22 R =0.01, F(1,305)=2.17, p=.14 R =0.003, F(1,301)=0.86, p=.35 23 Model 2 0.20 0.16 0.12 – 0.52 1.23 0.18 0.21 0.59 – 0.23 0.86 2 2 24 R =0.44, F(18,284)=11.22, p<.001 R =0.37, F(18,280)=7.19, p<.001 25 Model 1: unadjusted; Model 2: adjusted for baseline wellbeing/depression, mother’s age, maternal education 26 status, household income and number of previous children, as well as how many weeks the baby was post-birth, 27 and the mother’s marital status at T2, whether she was working at T1 or T2 and whether her partner was working 28 at T2 and previous histories of both anxiety and depression. *p<.05, **p<.01, ***p<.001 29 30 between listening and baseline depression (B=0.09, SE=0.04, 95%CI 0.17 to 0.01), with a twoway 31 contour graph showing that listening to music particularly seemed to support those who were showing

32 http://bmjopen.bmj.com/ 33 symptoms of PND (evidenced with a score of 10+ at baseline) (see Supplementary Figure 1B). 34 35 36 37 38 39 Finally, in order to try and ascertain whether listening to music led to changes in mental health or

40 whether mental health led to changes in listening habits, we ran additional analyses reversing the on September 25, 2021 by guest. Protected copyright. 41 42 variable order. While this does not confirm potential causal mechanisms, it can give an indication as 43 to whether mental health can predict listening behaviours and therefore support hypotheses about 44 45 temporal precedence. There was no evidence that levels of wellbeing during pregnancy were 46 associated with the likelihood of listening to music either 3 or 6 months postbirth. However, there 47 48 was some indication that depression symptoms in the final trimester of pregnancy were associated 49 with listening habits 3 months postbirth (β=0.03, SE=0.01, 95%CI 0.05 to 0.01, p=.003). 50 51 52 Discussion 53 54 This study explored associations between listening to music in the final trimester of pregnancy and 55 mental health and wellbeing in mothers postbirth. Listening was found to be associated with higher 56 57 58 10 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 19 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 levels of wellbeing and reduced symptoms of PND in the first 3 months postbirth, even when 4 adjusting for baseline mental health and potential confounding variables. These results appear to be 5 6 particularly found amongst women with lower levels of wellbeing at baseline. These findings echo the 7 few existing studies in showing that listening to music is associated with better mental health in the 8 9 perinatal period (30,31). However, to the authors’ knowledge, this is the first study to show that 10 listening to music during pregnancy is longitudinally associated with better mental health postbirth. 11 12 13 Across both symptoms of PND and wellbeing, however, associations were only found for the first 3 14 15 months postbirth, and had disappeared by the second quartile postbirth. The hypnosis study 16 previously describedFor also found peer results within review the first 3 months postpartumonly (weeks 2 and 10) but did 17 18 not measure beyond this, so there is little data available against which to benchmark these findings 19 (16). Nevertheless, the immediate period postbirth has been highlighted as being of particular 20 21 challenge for new mothers, with the transition into assuming maternal tasks and adjusting to the new 22 role lasting until around the third month postpartum (13,34). It is possible, therefore, that any effects 23 24 of music listening during the prenatal period are of most value during this transition period, but 25 become less significant once mothers and their babies become more settled. 26 27 28 A key question is how listening to music is associated with better mental health and wellbeing in the 29 30 postnatal period. There are a number of potential explanations. First, studies involving psychological 31 tests, neuroimaging, biomarker analyses and ethnographic observations have shown that listening to

32 http://bmjopen.bmj.com/ music can have marked effects on stress and anxiety (25). Specifically in relation to pregnant women, 33 34 listening to music for just 30 minutes can reduce cortisol levels and anxiety (29). Wider studies 35 involving listening to music have shown it to be particularly effective at reducing psychological and 36 37 physiological responses to stress, especially when people deliberately listen to music in order to help 38 them relax (35,36). This effect of music on stress has in turn been linked specifically through to 39

40 theories around wellbeing (25,37), with a wide literature linking stress and anxiety with both mental on September 25, 2021 by guest. Protected copyright. 41 health and wellbeing (38,39). It is proposed that high levels of anxiety might hinder women’s 42 43 adaptation to motherhood in the initial postpartum period, with negative effects on wellbeing (40). 44 Consequently, it is possible that the relaxing effects of listening to music during the pregnancy period 45 46 helps to act as a buffer for feelings of stress and anxiety, thereby supporting mothers in maintaining 47 their adaptation and leading to enhanced wellbeing. 48 49 50 Another potential explanation relates to the effects of music on mood. Mood regulation has been 51 52 identified as one of the prime reasons why people listen to music, with models of mood regulation by 53 music highlighting its effects on moodrelated subjective experience (including the intensity and 54 55 clarity of moods), physiological responses (such as energy levels and movement) and behaviours 56 (such as their ability to express emotions) (41). Music listening has been found to modulate 57 58 11 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 19

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 depression and wellbeing (42,43). Early low mood during the prenatal period is directly associated 4 with lower wellbeing and postnatal depression postbirth (44), leading to propositions that 5 6 interventions that deliberately attempt to cultivate positive emotions, such as relaxation therapies and 7 interventions focused on finding positive meaning, could directly optimise health and wellbeing in 8 9 this population. Consequently, it is possible that another route by which listening to music in the third 10 trimester of pregnancy is associated with improvements in mental health and wellbeing is via 11 12 enhancing mood. 13 14 15 Finally, a third explanation is that listening to music in itself did not have an effect postbirth but did 16 enhance coping skillsFor in women peer while they reviewwere still pregnant, whichonly in turn led to higher wellbeing 17 18 postbirth. Music listening has been linked with both problemoriented coping and emotionoriented 19 coping, specifically with results showing that problemoriented coping by music listening in women is 20 21 linked to lower depression levels (45). Life transitions (such as the perinatal period) depend on both 22 health and wellbeing and also on appraisal and coping responses. In the hypnosis study previously 23 24 mentioned, the authors proposed that the intervention during pregnancy helped mothers to maintain 25 and enhance their wellbeing whilst pregnant, which in turn influenced their appraisal of the perinatal 26 27 transition period and supported their coping responses (16). It is possible that a similar process took 28 place through listening to music, with listening to music supporting coping in the prenatal period, 29 30 which encouraged mothers’ own coping skills, which in turn led to better coping during and postbirth 31 and consequent higher wellbeing. Indeed, even just in relation to the birth, a number of birth

32 http://bmjopen.bmj.com/ preparation courses focus on relaxation and mood optimisation, which have been shown to lead to less 33 34 negative affect and better coping during labour and delivery (46). Given that a significant predictor of 35 PND is the birth experience, enhanced coping prior to the birth, perhaps through music listening, 36 37 could be an important factor in postnatal wellbeing (47). 38

40 This study has a number of limitations. First, the study followed a cohort of women rather than being on September 25, 2021 by guest. Protected copyright. 41 interventional, so it is not possible to confirm causality. However, the study had a longitudinal design, 42 43 there was no evidence of reverse causality in relation to wellbeing, there are plausible proposed 44 mechanistic explanations, and there is a strong body of previous literature causally linking music and 45 46 mental health in other populations. So this study provides promising preliminary evidence that 47 remains to be tested in a future experimental design. A second limitation is that the population in this 48 49 study was not nationally representative. Nevertheless, there was a clear spread of participants from 50 varying socioeconomic backgrounds as well as variations in the levels of exposure and outcome 51 52 variables. So the dataset provides interesting and suitable preliminary data on the longitudinal 53 associations between music listening and mental health. Third, this study explored the impact of all 54 55 music listening, not specifying particular genres. Previous research has suggested that certain genres 56 of music (or more specifically compositional aspects of music such as its valence and arousal levels) 57 58 12 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 19 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 can lead to different responses, such as variations in relaxation or mood (48). However, most of these 4 genrespecific effects have been found in tightlycontrolled labbased studies, and literature from real 5 6 world interaction with music has suggested that musical preference might be more important in 7 determining the effects of music (49). This study followed these realworld studies in recording what 8 9 genres people did listen to but measuring the quantity of listening based on preference rather than 10 genre. Future studies could explore the impact of different genres on mental health in the perinatal 11 12 period. 13 14 15 In conclusion, this study provides the first preliminary evidence that listening to music during the 16 third trimester of Forpregnancy peercould be protective review against symptoms only of PND and low wellbeing in the 17 18 first three months postbirth. Music listening is an attractive intervention in that it is readily available 19 to people from all echelons of society regardless of socioeconomic status, educational attainment or 20 21 cultural background. It can be carried out in a range of contexts so is not restricted to particular places 22 or times. It is also inexpensive: indeed the majority of women in the Western countries have access to 23 24 recorded music already. Finally, there are no obvious side effects from listening to music. 25 Consequently, listening to music could be recommended as a way of supporting pregnant women; in 26 27 particular those who demonstrate low wellbeing or symptoms of PND. 28 29 30 Authors’ contributions 31 DF and RP designed the study and collected data. DF ran the analyses and drafted the paper. Both

32 http://bmjopen.bmj.com/ authors critically revised the manuscript and approved it for submission. 33 34 35 36 Data sharing statement 37 38 The data in this study are available from the authors upon request. 39

40 on September 25, 2021 by guest. Protected copyright. 41 Patient public involvement 42 This study was developed as part of a wider grant that involved mothers, psychiatrists and health 43 44 workers in the design of the research questions, the choice of measures and the recruitment for the 45 study. We also involved these groups in the dissemination of the results. 46

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32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

1 Supplementary Figure 1: Contour graphs showing the interaction between 2 3 baseline mental health and music listening habits on mental health post-birth

4 BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 5 6 A 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 B 35

36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43

44 on September 25, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Notes. Frequency of music listening at Q1: 1=rarely; 2=a couple of times a week; 3=every day <1hr; 4=every day 1-2hrs; 5=every day 3-5hrs; 6=every day 5+hrs

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1 confounders were adjusted for and why they were included 2 (b) Report category boundaries when continuous variables were categorized 3

36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43

44 on September 25, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from

Could listening to music during pregnancy be protective against postnatal depression and poor wellbeing post-birth? Longitudinal associations from a preliminary prospective cohort study.

ForJournal: peerBMJ Open review only

Manuscript ID bmjopen-2017-021251.R2

Article Type: Research

Date Submitted by the Author: 24-May-2018

Primary Subject Mental health Heading:

Secondary Subject Heading: Obstetrics and gynaecology

MENTAL HEALTH, Depression & mood disorders < PSYCHIATRY, Maternal http://bmjopen.bmj.com/ Keywords: medicine < OBSTETRICS

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23 24 25 26 27 28 29 30 31

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BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Abstract 4 Objectives: This study explored whether listening to music during pregnancy is longitudinally 5 6 associated with lower symptoms of postnatal depression and higher wellbeing in mothers postbirth. 7 8 9 Design: Prospective cohort study. 10 11 12 Participants: We analysed data from 395 new mothers aged over 18 who provided data in the third 13 trimester of pregnancy and 3 and 6 months later (03 and 46 months post birth). 14 15 16 Primary and secondaryFor outcome peer measures: reviewPostnatal depression onlywas measured using the Edinburgh 17 18 Postnatal Depression Scale (EPDS), and wellbeing was measured using the Short WarwickEdinburgh 19 Mental Wellbeing Scale (SWEMWBS). Our exposure was listening to music and was categorised as 20 21 ‘rarely; a couple of times a week; every day <1hr; every day 12hrs; every day 35hrs; every day 22 5+hrs’. Multivariable linear regression analyses were carried out to explore the effects of listening to 23 24 music during pregnancy on depression and wellbeing post birth, adjusted for baseline mental health 25 and potential confounding variables. 26 27 28 Results: Listening during pregnancy is associated with higher levels of wellbeing (β=0.40, SE=0.15, 29 30 95%CI 0.10 to 0.70) and reduced symptoms of postnatal depression (β=0.39, SE=0.19, 95%CI 0.76 31 to 0.03) in the first 3 months postbirth. However, effects disappear by 46 months postbirth. These

32 http://bmjopen.bmj.com/ results appear to be particularly found amongst women with lower levels of wellbeing and high levels 33 34 of depression at baseline. 35

36 37 Conclusions: Listening to music could be recommended as a way of supporting mental health and 38 wellbeing in pregnant women; in particular those who demonstrate low wellbeing or symptoms of 39

40 postnatal depression. on September 25, 2021 by guest. Protected copyright. 41

30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Introduction 4 Perinatal mental health problems affect around 20% of women at some point during the perinatal 5 6 period (1). In terms of conditions characterised by negative symptomology, postnatal depression 7 (PND) is one of the most common problems, and is a debilitating condition with symptoms including 8 9 fatigue, irritability, insomnia and anhedonia; symptoms which in 25% of affected women last for at 10 least one year (2). Over the last two decades, there has been significant research into the effects of 11 12 PND on mother and infant as well as attention paid to how it can be prevented or managed (3,4). 13 However, in terms of conditions relating more to the absence of positive symptomology, such as low 14 15 hedonic or eudemonic wellbeing, there has been much less research. The few studies that do exist 16 have found that negativeFor mood, peer as indicated review by the Edinburgh Postnatalonly Depression Scale (EPDS), 17 18 has a correlation of just 0.46 with positive experiences of motherhood, as indicated by a principal 19 component analysis of six experiences of motherhood (POSMO) (5). This suggests that, as in the 20 21 wider population, depression and wellbeing are separate constructs in the context of perinatal mental 22 health and a positive perinatal experience is more than simply the inversion of negative mood (6). 23 24 Building on this, women even without PND have been found to demonstrate impairments in 25 emotional problems and vitality, suggesting that even in the absence of depression mothers can have 26 27 impaired wellbeing (7). In light of this, a review has argued that psychological wellbeing defined as a 28 multidimensional construct should be an integral part of maternity care (8), and a more recent 29 30 construct analysis has highlighted the importance not just of identifying PND but also of identifying 31 women with suboptimal perinatal wellbeing and supporting them to achieve positive psychological

40 birth. We therefore focused on women in the longitudinal study who had provided complete data on on September 25, 2021 by guest. Protected copyright. 41 the variables we selected for analyses at both T1 and T2: 395 women. However, we also ran some 42 43 exploratory followup analyses with women who had also provided complete data at T3 (n=299) in 44 order to explore if effects were maintained. 45 46 47 Patient public involvement 48 49 This study was developed as part of a wider grant that involved mothers, psychiatrists and health 50 workers in the design of the research questions, the choice of measures and the recruitment for the 51 52 study. We also involved these groups in the dissemination of the results. 53 54 55 Measures 56 57 58 6 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 21 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Symptoms of PND were measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10item 4 scale used extensively both with pregnant women and new mothers, scored from 030 with 10+ 5 6 indicative of possible symptoms of depression and higher scores of 13+ indicating more severe 7 depression (32). 8 9 10 Wellbeing was measured using the Short WarwickEdinburgh Mental Wellbeing Scale 11 12 (SWEMWBS), a scale that encompasses both hedonic and eudemonic wellbeing comprising 7 items 13 scored from 7 to 35 with higher scores representing higher levels of wellbeing. The raw scores were 14 15 logittransformed prior to analysis (33). The New Economics Foundation (NEF) suggests five levels 16 of wellbeing basedFor on quintile peer analyses of datareview in the UK Understanding only Society Survey, 2009: poor 17 18 (<22), below average (2224), average (2526), good (2728) and excellent (2935). 19 20 21 In addition, demographic variables assessed the women’s number of weeks pregnant/postbirth, 22 number of other children (0, 1, 2, 3 and 4+), household income (<£16,000, £16,000£30,000, £31,000 23 24 £60,000, £61,000£90,000, >£90,000), educational attainment (school to 16, sixth form/college, 25 undergraduate degree, postgraduate degree), marital status (married vs not married), employment 26 27 status (working vs not working), partner’s employment status (working vs not working) and whether 28 the woman had previously been diagnosed with either anxiety or depression. 29 30 31 Listening to music was categorised as ‘rarely; a couple of times a week; every day <1hr; every day 1

32 http://bmjopen.bmj.com/ 2hrs; every day 35hrs; every day 5+hrs’. While these analyses focused on quantity of music listening 33 34 as a predictor, we also recorded genre of music listened to. 35

36 37 Statistics 38 Data were analysed using Stata v14. Multivariable linear regression models were used to explore the 39

40 effects of listening to music on wellbeing and PND. Frequency of listening to music had a normal on September 25, 2021 by guest. Protected copyright. 41 distribution so was treated as a 6point linear variable, with higher score indicating more frequent 42 43 listening. For wellbeing and PND, we used raw scores. Model 1 was unadjusted, while Model 2 44 adjusted for baseline wellbeing/depression, mother’s age, maternal education status, household 45 46 income and number of previous children, as well as how many weeks the baby was postbirth, and the 47 mother’s marital status at T2, whether she was working at T1 or T2, whether her partner was working 48 49 at T2, and previous histories of both anxiety and depression. 50 51 52 All models displayed linearity as assessed by augmented partial residual plots with lowess smoothing; 53 multicollinearity as assessed by checking variance inflation factors; normality as assessed using 54 55 kernel density plots, standardised normal probability (PP) plots and QQ plots; and there was no 56 evidence of outliers or undue influence as assessed using added variable plots regressing each variable 57 58 7 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 21

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 against all others, through stem and leaf plots, and through assessing covariance ratios, Cook’s 4 distance and leverage. The wellbeing regression models demonstrated homoscedasticity as assessed 5 6 by plotting the residuals versus fitted (predicted) values and using the BreuschPagan test for 7 heteroskedasticity. However, the depression regression models showed signs of heteroskedasticity, so 8 9 robust standard errors were calculated. 10 11 12 Planned sensitivity analyses were then conducted in order to ascertain whether baseline mental health 13 during pregnancy was a moderator of the association between listening to music and mental health 14 15 post birth. For this, we included an interaction term of Q1 mental health and Q1 listening habits in our 16 regression modelsFor and then peer plotted twoway review contour graphs only to visualise the interaction (see 17 18 Supplementary Figure 1). 19 20 21 Although there were no significant demographic differences between those who did and did not 22 provide data at Q3, we wanted to take account of potential minor demographic differences between 23 24 those who provided data at Q3 and those who failed to. So the propensity score for nonresponse was 25 calculated using the indicators listed in Model 2 above (none of which significantly predicted 26 27 missingness) and inverse probability weighting was applied to the T3 regression models. We 28 confirmed goodness of fit using the HosmerLemeshow test. Weighted analyses did not differ from 29 30 unweighted analyses. 31

32 http://bmjopen.bmj.com/ Results 33 34 Demographics. At T1, women had an average age of 31.9 years (SD=4.9, range 1847) and an 35 average of 32.9 weeks pregnant (SD=4.1, range 2842). Further demographics are provided in Table 36 37 1. 38

40 Table 1: Demographic information on participants on September 25, 2021 by guest. Protected copyright. 41 N=395 42 Maternal age, µ (SD) 31.9 (4.9) 43 Infant age, µ (SD) 32.9 (4.1) 44 45 Marital status, % 46 Married 69.3 47 Cohabiting 25.9 48 In a relationship but living separately 3.8 49 Single 1 50 Partner working, % 97.0 51 Educational attainment, % 52 Education to 16) 13.2 53 Education to 18 16.5 54 Undergraduate degree/qualification 41.3 55 Postgraduate degree/qualification 29.1 56 Household income, % 57 58 8 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 21 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 < £16,000 6.6 4 £16,000£30,000 11.1 5 £31,000£60,000 52.9 6 £61,000££90,000 17.5 7 > £91,000 11.9 8 Frequency of music listening, % 9 Rarely 5.6 10 A couple of times a week 17.2 11 Daily < 1 hour 34.4 12 Daily 12 hours 29.9 13 Daily 35 hours 8.6 14 Daily 5+ hours 4.3 15 Genre of music listened to, % 16 Jazz For peer review21.0 only 17 Pop 93.7 18 Rock 57.7 19 Classical 34.2 20 Folk 22.8 21 R&B 42.8 22 23 24 25 26 27 The average wellbeing score at T1 was 24.1 (SD=3.9, range 11.2535), at T2 was 23.9 (SD=4.3, range 28 735) and at T3 was 23.8 (SD=4.1, range 735) (Table 2). In order to calculate the change in 29 30 wellbeing amongst these women, we analysed the difference in scores from T1 to T2 and T1 to T3. 31 39.2% of mothers experienced a decrease or at least 1 point in their wellbeing from T1 to T2, while

32 http://bmjopen.bmj.com/ 33 30.4% experienced no change and 30.4% experienced an improvement of at least 1 point. From T1 to 34 T3, 41.4% of mothers experienced a decrease or at least 1 point in their wellbeing, while 25.7% 35 36 experienced no change and 32.9% experienced an improvement of at least 1 point. 37 38 39 Table 2: Levels of wellbeing and postnatal depression during pregnancy (T1), 0-3 months post-

40 birth (T2) and 4-6 months post-birth (T3). on September 25, 2021 by guest. Protected copyright. 41 42 T1 T2 T3 43 Wellbeing 44 Poor (<22) 29.4% 31.1% 31.6% 45 Below average (2224) 25.6% 24.1% 25.4% 46 Average (2526) 23.5% 21.3% 20.9% 47 Good (2728) 10.1% 11.7% 13.7% 48 Excellent (2935) 11.4% 11.9% 8.5% 49 Depression 50 EPDS<10 74.7% 72.2% 73.3% 51 EPDS>=10 25.3% 27.9% 26.7% 52 53 54 As with wellbeing, we calculated the change in symptoms of PND from T1 to T2 and T1 to T3 (table 55 2). 43.6% of mothers experienced an increase in the number of symptoms of PND they were 56 57 58 9 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 21

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 experiencing from T1 to T2, while 11.2% experienced no change, and 45.3% of mothers experienced 4 an improvement in symptoms. From T1 to T3, 56.4% of mothers experienced an increase in the 5 6 number of symptoms of PND they were experiencing, while 11.6% experienced no change and 43.6% 7 experienced an improvement in symptoms. In terms of the interaction between wellbeing and 8 9 symptoms of PND, there was a large correlation between the two at T1 (r=0.67, p<.001), T2 (r= 10 0.76, p<.001) and T3 (r=0.77, p<.001). 11 12 13 Regression results: Listening to music while pregnant was associated with higher raw wellbeing 14 15 scores 03 months postbirth, even when accounting for potential confounding variables, with greater 16 For peer review only 17 Wellbeing Symptoms of PND 18 19 20 21 22 23 24 25 26 27 28 frequency associated with greater effects (B=0.40, SE=0.15, 95%CI 0.10 to 0.70) (see Table 3). 29 However, our exploratory analyses showed that effects were not evident 46 months postbirth. There 30 31 was also an association between listening to music while pregnant and raw scores of symptoms of

32 PND, even when accounting for potential confounding variables, with more frequent listening to http://bmjopen.bmj.com/ 33 34 music during pregnancy associated with lower symptoms of PND in the first 3 months postbirth (B= 35 0.39, SE=0.19, 95%CI 0.76 to 0.03). As with wellbeing, these results were no longer evident by 36 37 months 46 postbirth. 38 39

40 Table 3: Associations between listening to music during pregnancy on wellbeing and symptoms on September 25, 2021 by guest. Protected copyright. 41 of postnatal depression post-birth 42 43 44 Further analyses: Sensitivity analyses of the wellbeing regression models explored the potential 45 46 moderating effect of mental health during pregnancy. Our analyses showed there was a significant 47 interaction between listening and baseline wellbeing (B=0.10 SE=0.04, 95%CI 0.17 to 0.02), with a 48 49 twoway contour graph showing that listening to music particularly seemed to support those with 50 lower wellbeing at baseline (see Supplementary Figure 1A). There was also a significant interaction 51 52 between listening and baseline depression (B=0.09, SE=0.04, 95%CI 0.17 to 0.01), with a twoway 53 contour graph showing that listening to music particularly seemed to support those who were showing 54 55 symptoms of PND (evidenced with a score of 10+ at baseline) (see Supplementary Figure 1B). 56 57 58 10 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 21 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 Months 0-3 post birth (n=395) 4 B SE 95% CI p B SE 95% CI p 5 Model 1 0.63 0.19 0.26 – 1.00 .001 -0.52 0.23 -0.98 – -0.06 .028 6 R2=0.03, F(1, 393)=11.44, p=.001 R2=0.01, F(1,393)=4.74, p=.03 7 Model 2 0.40 0.15 0.10 - 0.70 .01 -0.39 0.19 -0.76 - -0.03 .036 8 R2=0.43, F(18,376)=15.97, p<.001 R2=0.39, F(18,376)=9.58, p<.001 9 Months 3-6 post birth (n=299) 10 B SE 95% CI p B SE 95% CI p 11 Model 1 0.33 0.21 0.079 – 0.74 .11 0.11 0.24 0.59 – 0.36 .63 12 R2=0.01, F(1,305)=2.17, p=.14 R2=0.003, F(1,301)=0.86, p=.35 13 Model 2 0.12 0.16 0.20 – 0.43 .47 0.02 0.20 0.41 – 0.36 .90 14 R2=0.44, F(18,284)=11.22, p<.001 R2=0.37, F(18,280)=7.19, p<.001 15 Model 1: unadjusted; Model 2: adjusted for baseline wellbeing/depression, mother’s age, maternal education 16 status, household incomeFor and number peer of previous reviewchildren, as well as howonly many weeks the baby was post-birth, 17 and the mother’s marital status at T2, whether she was working at T1 or T2 and whether her partner was working 18 at T2 and previous histories of both anxiety and depression. *p<.05, **p<.01, ***p<.001 19 20 21 22 Finally, in order to try and ascertain whether listening to music led to changes in mental health or 23 whether mental health led to changes in listening habits, we ran additional analyses reversing the 24 25 variable order. While this does not confirm potential causal mechanisms, it can give an indication as 26 to whether mental health can predict listening behaviours and therefore support hypotheses about 27 28 temporal precedence. There was no evidence that levels of wellbeing during pregnancy were 29 associated with the likelihood of listening to music either 3 or 6 months postbirth. However, there 30 31 was some indication that depression symptoms in the final trimester of pregnancy were associated

32 with listening habits 3 months postbirth (β=0.03, SE=0.01, 95%CI 0.05 to 0.01, p=.003). http://bmjopen.bmj.com/ 33 34 35 Discussion 36 This study explored associations between listening to music in the final trimester of pregnancy and 37 38 mental health and wellbeing in mothers postbirth. Listening was found to be associated with higher 39 levels of wellbeing and reduced symptoms of PND in the first 3 months postbirth, even when

40 on September 25, 2021 by guest. Protected copyright. 41 adjusting for baseline mental health and potential confounding variables. These results appear to be 42 particularly found amongst women with lower levels of wellbeing at baseline. These findings echo the 43 44 few existing studies in showing that listening to music is associated with better mental health in the 45 perinatal period (30,31). However, to the authors’ knowledge, this is the first study to show that 46 47 listening to music during pregnancy is longitudinally associated with better mental health postbirth. 48 49 50 Across both symptoms of PND and wellbeing, however, associations were only found for the first 3 51 months postbirth, and had disappeared by the second quartile postbirth. The hypnosis study 52 53 previously described also found results within the first 3 months postpartum (weeks 2 and 10) but did 54 not measure beyond this, so there is little data available against which to benchmark these findings 55 56 (16). Nevertheless, the immediate period postbirth has been highlighted as being of particular 57 58 11 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 21

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 challenge for new mothers, with the transition into assuming maternal tasks and adjusting to the new 4 role lasting until around the third month postpartum (13,34). It is possible, therefore, that any effects 5 6 of music listening during the prenatal period are of most value during this transition period, but 7 become less significant once mothers and their babies become more settled. 8 9 10 A key question is how listening to music is associated with better mental health and wellbeing in the 11 12 postnatal period. There are a number of potential explanations. First, studies involving psychological 13 tests, neuroimaging, biomarker analyses and ethnographic observations have shown that listening to 14 15 music can have marked effects on stress and anxiety (25). Specifically in relation to pregnant women, 16 listening to musicFor for just 30peer minutes can review reduce cortisol levels only and anxiety (29). Wider studies 17 18 involving listening to music have shown it to be particularly effective at reducing psychological and 19 physiological responses to stress, especially when people deliberately listen to music in order to help 20 21 them relax (35,36). This effect of music on stress has in turn been linked specifically through to 22 theories around wellbeing (25,37), with a wide literature linking stress and anxiety with both mental 23 24 health and wellbeing (38,39). It is proposed that high levels of anxiety might hinder women’s 25 adaptation to motherhood in the initial postpartum period, with negative effects on wellbeing (40). 26 27 Consequently, it is possible that the relaxing effects of listening to music during the pregnancy period 28 helps to act as a buffer for feelings of stress and anxiety, thereby supporting mothers in maintaining 29 30 their adaptation and leading to enhanced wellbeing. 31

32 http://bmjopen.bmj.com/ Another potential explanation relates to the effects of music on mood. Mood regulation has been 33 34 identified as one of the prime reasons why people listen to music, with models of mood regulation by 35 music highlighting its effects on moodrelated subjective experience (including the intensity and 36 37 clarity of moods), physiological responses (such as energy levels and movement) and behaviours 38 (such as their ability to express emotions) (41). Music listening has been found to modulate 39

40 depression and wellbeing (42,43). Early low mood during the prenatal period is directly associated on September 25, 2021 by guest. Protected copyright. 41 with lower wellbeing and postnatal depression postbirth (44), leading to propositions that 42 43 interventions that deliberately attempt to cultivate positive emotions, such as relaxation therapies and 44 interventions focused on finding positive meaning, could directly optimise health and wellbeing in 45 46 this population. Consequently, it is possible that another route by which listening to music in the third 47 trimester of pregnancy is associated with improvements in mental health and wellbeing is via 48 49 enhancing mood. 50 51 52 Finally, a third explanation is that listening to music in itself did not have an effect postbirth but did 53 enhance coping skills in women while they were still pregnant, which in turn led to higher wellbeing 54 55 postbirth. Music listening has been linked with both problemoriented coping and emotionoriented 56 coping, specifically with results showing that problemoriented coping by music listening in women is 57 58 12 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 21 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 linked to lower depression levels (45). Life transitions (such as the perinatal period) depend on both 4 health and wellbeing and also on appraisal and coping responses. In the hypnosis study previously 5 6 mentioned, the authors proposed that the intervention during pregnancy helped mothers to maintain 7 and enhance their wellbeing whilst pregnant, which in turn influenced their appraisal of the perinatal 8 9 transition period and supported their coping responses (16). It is possible that a similar process took 10 place through listening to music, with listening to music supporting coping in the prenatal period, 11 12 which encouraged mothers’ own coping skills, which in turn led to better coping during and postbirth 13 and consequent higher wellbeing. Indeed, even just in relation to the birth, a number of birth 14 15 preparation courses focus on relaxation and mood optimisation, which have been shown to lead to less 16 negative affect andFor better coping peer during labour review and delivery (46). onlyGiven that a significant predictor of 17 18 PND is the birth experience, enhanced coping prior to the birth, perhaps through music listening, 19 could be an important factor in postnatal wellbeing (47). 20 21 22 This study has a number of limitations. First, the study followed a cohort of women rather than being 23 24 interventional, so it is not possible to confirm causality. However, the study had a longitudinal design, 25 there was no evidence of reverse causality in relation to wellbeing, there are plausible proposed 26 27 mechanistic explanations, and there is a strong body of previous literature causally linking music and 28 mental health in other populations. So this study provides promising preliminary evidence that 29 30 remains to be tested in a future experimental design. A second limitation is that the population in this 31 study was not nationally representative. Nevertheless, there was a clear spread of participants from

32 http://bmjopen.bmj.com/ varying socioeconomic backgrounds as well as variations in the levels of exposure and outcome 33 34 variables. So the dataset provides interesting and suitable preliminary data on the longitudinal 35 associations between music listening and mental health. Third, this study explored the impact of all 36 37 music listening, not specifying particular genres. Previous research has suggested that certain genres 38 of music (or more specifically compositional aspects of music such as its valence and arousal levels) 39

40 can lead to different responses, such as variations in relaxation or mood (48). However, most of these on September 25, 2021 by guest. Protected copyright. 41 genrespecific effects have been found in tightlycontrolled labbased studies, and literature from real 42 43 world interaction with music has suggested that musical preference might be more important in 44 determining the effects of music (49). This study followed these realworld studies in recording what 45 46 genres people did listen to but measuring the quantity of listening based on preference rather than 47 genre. Future studies could explore the impact of different genres on mental health in the perinatal 48 49 period. 50 51 52 In conclusion, this study provides the first preliminary evidence that listening to music during the 53 third trimester of pregnancy could be protective against symptoms of PND and low wellbeing in the 54 55 first three months postbirth. Music listening is an attractive intervention in that it is readily available 56 to people from all echelons of society regardless of socioeconomic status, educational attainment or 57 58 13 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 21

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 cultural background. It can be carried out in a range of contexts so is not restricted to particular places 4 or times. It is also inexpensive: indeed the majority of women in the Western countries have access to 5 6 recorded music already. Finally, there are no obvious side effects from listening to music. 7 Consequently, listening to music could be recommended as a way of supporting pregnant women; in 8 9 particular those who demonstrate low wellbeing or symptoms of PND. 10 11 12 Authors’ contributions 13 DF and RP designed the study and collected data. DF ran the analyses and drafted the paper. Both 14 15 authors critically revised the manuscript and approved it for submission. 16 For peer review only 17 18 Data sharing statement 19 20 The data in this study are available from the authors upon request. 21 22 23 References 24 1. Khalifeh H, Brauer R, Toulmin H, Howard LM. Perinatal mental health: What every 25 neonatologist should know. Early Hum Dev. 2015 Nov 1;91(11):649–53. 26 2. Morrell C, Warner R, Slade P, Dixon S, Walters S, Paley G, et al. Psychological 27 interventions for postnatal depression: cluster randomised trial and economic 28 evaluation. The PoNDER trial. Health Technol Assess [Internet]. 2009 Jun [cited 2016 29 Jul 26];13(30). Available from: http://www.journalslibrary.nihr.ac.uk/hta/volume 30 13/issue30 31 3. Cooper PJ, Murray L. Postnatal depression. BMJ. 1998 Jun 20;316(7148):1884–6.

32 4. Junge C, GarthusNiegel S, Slinning K, Polte C, Simonsen TB, EberhardGran M. The http://bmjopen.bmj.com/ 33 Impact of Perinatal Depression on Children’s SocialEmotional Development: A 34 Longitudinal Study. Matern Child Health J. 2017 Mar 1;21(3):607–15. 35 5. Green JM, Kafetsios K. Positive experiences of early motherhood: Predictive variables 36 from a longitudinal study. J Reprod Infant Psychol. 1997 May 1;15(2):141–57. 37 6. Keyes CL. Mental Illness and/or Mental Health? Investigating Axioms of the Complete 38 State Model of Health. J Consult Clin Psychol. 2005;73(3):539–48. 39 7. Boyce PM, Johnstone SJ, Hickey AR, MorrisYates AD, Harris MG, Strachan T.

40 Functioning and wellbeing at 24 weeks postpartum of women with postnatal on September 25, 2021 by guest. Protected copyright. 41 depression. Arch Womens Ment Health. 2000 Dec 11;3(3):91–7. 42 8. Jomeen J. The importance of assessing psychological status during pregnancy, 43 childbirth and the postnatal period as a multidimensional construct: A literature review. 44 Clin Eff Nurs. 2004 Sep;8(3–4):143–55. 45 9. Allan C, CarrickSen D, Martin CR. What is perinatal wellbeing? A concept analysis 46 and review of the literature: J Reprod Infant Psychol [Internet]. 2013 [cited 2017 Jun 47 8];31(4). Available from: 48 http://www.tandfonline.com/doi/abs/10.1080/02646838.2013.791920 49 10. Beck CT. Predictors of postpartum depression: an update. Nurs Res. 2001 50 Oct;50(5):275–85. 51 11. Milgrom J, Gemmill AW, Bilszta JL, Hayes B, Barnett B, Brooks J, et al. Antenatal risk 52 factors for postnatal depression: a large prospective study. J Affect Disord. 2008 53 May;108(1–2):147–57. 54 12. Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum 55 depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul;26(4):289– 56 95. 57 58 14 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 21 BMJ Open

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40 on September 25, 2021 by guest. Protected copyright. /pmcc/articles/PMC3740499/?report=abstract 41 29. Ventura T, Gomes MC, Carreira T. Cortisol and anxiety response to a relaxing 42 intervention on pregnant women awaiting amniocentesis. Psychoneuroendocrinology. 43 2012 Jan;37(1):148–56. 44 30. Nwebube C, Glover V, Stewart L. Prenatal listening to songs composed for pregnancy 45 and symptoms of anxiety and depression: a pilot study. BMC Complement Altern Med. 46 2017 May 8;17(1):256. 47 31. Fancourt D, Perkins R. Associations between singing to babies and symptoms of 48 postnatal depression, wellbeing, selfesteem and motherinfant bond. Public Health. 49 2017 Apr 1;145:149–52. 50 32. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of 51 the 10item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun 52 1;150(6):782–6. 53 33. StewartBrown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal 54 construct validity of the WarwickEdinburgh Mental Wellbeing Scale (WEMWBS): a 55 Rasch analysis using data from the Scottish Health Education Population Survey. 56 Health Qual Life Outcomes. 2009;7:15. 57 58 15 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 21

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 34. Pridham KF, Chang AS. Transition to being the mother of a new infant in the first 3 4 months: maternal problem solving and selfappraisals. J Adv Nurs. 1992 5 Feb;17(2):204–16. 6 35. Krout RE. The effects of singlesession music therapy interventions on the observed 7 and selfreported levels of pain control, physical comfort, and relaxation of hospice 8 patients. Am J Hosp Palliat Med. 2001 Dec;18(6):383–90. 9 36. Linnemann A, Strahler J, Nater UM. The stressreducing effect of music listening varies 10 depending on the social context. Psychoneuroendocrinology. 2016 Oct 1;72:97–105. 11 37. Krout RE. Music listening to facilitate relaxation and promote wellness: Integrated 12 aspects of our neurophysiological responses to music. Arts Psychother. 13 2007;34(2):134–41. 14 38. Iwata M, Ota KT, Duman RS. The inflammasome: pathways linking psychological 15 stress, depression, and systemic illnesses. Brain Behav Immun. 2013 Jul;31:105–14. 16 39. Vedhara K,For Miles J, Bennettpeer P, Plummer review S, Tallon D, Brooksonly E, et al. An investigation 17 into the relationship between salivary cortisol, stress, anxiety and depression. Biol 18 Psychol. 2003 Feb;62(2):89–96. 19 40. Pond E, Kemp V. A comparison between adolescent and adult women on prenatal 20 anxiety and selfconfidence. Matern Child Nurs J. 1992;20(1):11–20. 21 41. Saarikallio S, Erkkilä J. The role of music in adolescents’ mood regulation. Psychol 22 Music. 2007 Jan 1;35(1):88–109. 23 42. Chin T, Rickard NS. Emotion regulation strategy mediates both positive and negative 24 relationships between music uses and wellbeing. Psychol Music. 2014 Sep 25 1;42(5):692–713. 26 43. Lai YM. Effects of Music Listening on Depressed Women in Taiwan. Issues Ment 27 Health Nurs. 1999 Jan 1;20(3):229–46. 28 44. Fleming A, N. Ruble D, L. Flett G, L. Shaul D. Postpartum Adjustment in FirstTime 29 Mothers: Relations Between Mood, Maternal Attitudes, and MotherInfant Interactions. 30 Dev Psychol. 1988 Jan 1;24:71–81. 31 45. Miranda D, Claes M. Music listening, coping, peer affiliation and depression in adolescence. Psychol Music. 2009 Apr 1;37(2):215–33. 32 http://bmjopen.bmj.com/ 46. Duncan S, J. Markman H. Intervention programs for the transition to parenthood: 33 Current status from a prevention perspective. 2017 Oct 26; 34 47. Green JM. Expectations and experiences of pain in labor: findings from a large 35 prospective study. Birth Berkeley Calif. 1993 Jun;20(2):65–72. 36 48. Labbe E, Schmidt N, Babin J, Pharr M. Coping with stress: the effectiveness of different 37 types of music. Appl Psychophysiol Biofeedback. 2007 Dec;32(3–4):163–8. 38 49. Fancourt D, Ockelford A, Belai A. The psychoneuroimmunological effects of music: A 39 systematic review and a new model. Brain Behav Immun. 2014 Feb;36:15–26.

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41 42 43 44 45 46 47 FOOTNOTE TO SUPPLEMENTARY FIGURE: These contour plots show the relationship between baseline 48 49 mental health and frequency of music listening and mental health post-birth. Darker regions indicate 50 higher wellbeing and higher depression scores post-birth. For wellbeing, these higher response values 51 52 seem to form a ridge running from the upper left to the lower right of the graph, suggesting that 53 more frequent music listening is associated with higher wellbeing post-birth even amongst those with 54 55 lower wellbeing during pregnancy. For depression, higher response values seem to form a ridge 56 57 58 16 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 21 BMJ Open

BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 running from the lower left to the upper right of the graph, suggesting that more frequent music 4 listening is associated with lower depression post-birth even amongst those with higher depression 5 6 during pregnancy. 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 25, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 17 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 18 of 21 BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Supplementary Figure 1A 31 32 These contour plots show the relationship between baseline mental health and frequency of music listening http://bmjopen.bmj.com/ 33 and mental health post-birth. Darker regions indicate higher wellbeing and higher depression scores post- 34 birth. For wellbeing, these higher response values seem to form a ridge running from the upper left to the 35 lower right of the graph, suggesting that more frequent music listening is associated with higher wellbeing 36 post-birth even amongst those with lower wellbeing during pregnancy. For depression, higher response values seem to form a ridge running from the lower left to the upper right of the graph, suggesting that 37 more frequent music listening is associated with lower depression post-birth even amongst those with higher 38 depression during pregnancy. 39

40 356x258mm (72 x 72 DPI) on September 25, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 19 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Supplementary Figure 1B 31 32 356x258mm (72 x 72 DPI) http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 25, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 20 of 21 BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 STROBE Statement—Checklist of items that should be included in reports of cohort studies 2 Item 3 No 4 Recommendation Page 5 Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the 1 6 abstract 7 (b) Provide in the abstract an informative and balanced summary of what was 2 8 done and what was found 9 10 Introduction 11 Background/rationale 2 Explain the scientific background and rationale for the investigation being 4-5 12 reported 13 Objectives 3 State specific objectives, including any prespecified hypotheses 5 14 15 Methods 16 Study design For4 Present peer key elements review of study design early inonly the paper 6 17 Setting 5 Describe the setting, locations, and relevant dates, including periods of 6 18 recruitment, exposure, follow-up, and data collection 19 a 20 Participants 6 ( ) Give the eligibility criteria, and the sources and methods of selection of 6 21 participants. Describe methods of follow-up 22 (b) For matched studies, give matching criteria and number of exposed and 23 unexposed 24 Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and 6-7 25 26 effect modifiers. Give diagnostic criteria, if applicable 27 Data sources/ 8* For each variable of interest, give sources of data and details of methods of 6-7 28 measurement assessment (measurement). Describe comparability of assessment methods if 29 there is more than one group 30 Bias 9 Describe any efforts to address potential sources of bias 7-8 31 Study size 10 Explain how the study size was arrived at 32 http://bmjopen.bmj.com/ 33 Quantitative 11 Explain how quantitative variables were handled in the analyses. If applicable, 6-7 34 variables describe which groupings were chosen and why 35 Statistical methods 12 (a) Describe all statistical methods, including those used to control for 7 36 confounding 37 b 38 ( ) Describe any methods used to examine subgroups and interactions 7-8 39 (c) Explain how missing data were addressed 8

40 (d) If applicable, explain how loss to follow-up was addressed 8 on September 25, 2021 by guest. Protected copyright. 41 (e) Describe any sensitivity analyses 7-8 42 43 Results 44 Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers 6 45 potentially eligible, examined for eligibility, confirmed eligible, included in the 46 study, completing follow-up, and analysed 47 (b) Give reasons for non-participation at each stage 48 49 (c) Consider use of a flow diagram 50 Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) 6 51 and information on exposures and potential confounders 52 (b) Indicate number of participants with missing data for each variable of N/A 53 interest 54 55 (c) Summarise follow-up time (eg, average and total amount) 6 56 Outcome data 15* Report numbers of outcome events or summary measures over time 8-9 57 Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates 8-9 58 and their precision (eg, 95% confidence interval). Make clear which 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 21 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-021251 on 17 July 2018. Downloaded from 1 confounders were adjusted for and why they were included 2 (b) Report category boundaries when continuous variables were categorized 3 (c) If relevant, consider translating estimates of relative risk into absolute risk 4 for a meaningful time period 5 6 Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and 9-10 7 sensitivity analyses 8 Discussion 9 Key results 18 Summarise key results with reference to study objectives 10 10 11 Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or 12 12 imprecision. Discuss both direction and magnitude of any potential bias 13 Interpretation 20 Give a cautious overall interpretation of results considering objectives, 12 14 limitations, multiplicity of analyses, results from similar studies, and other 15 relevant evidence 16 For peer review only 17 Generalisability 21 Discuss the generalisability (external validity) of the study results 12 18 Other information 19 Funding 22 Give the source of funding and the role of the funders for the present study and, 3 20 if applicable, for the original study on which the present article is based 21 22 23 *Give information separately for exposed and unexposed groups. 24 25 Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and 26 published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely 27 28 available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at 29 http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is 30 available at http://www.strobe-statement.org. 31

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40 on September 25, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml