Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers

Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers Corinna Colella, Jenny McNeill, Una McCann, Fiona A. Lynn This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3574802/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 Apr, 2025 Read the published version in Pilot and Feasibility Studies → Version 1 posted 5 You are reading this latest preprint version Abstract Background Postnatal mothers can experience anxiety, stress, and difficulty with mother-infant attachment with potential to lead to an anxiety disorder/depression. There has been an increase in interest in non-pharmacological interventions involving music, with limited evidence assessing effectiveness in this population within randomised controlled trials (RCTs). Mamas in Harmony is a novel music/social support intervention. The objective is to assess the feasibility/acceptability of conducting a full RCT to test the effect and cost-effectiveness of Mamas in Harmony compared with usual care. Methods The pilot RCT aims to recruit 60 mother-infant dyads through social media, community organisations and stakeholder networks, randomly allocated on a 2:1 ratio to the intervention and control group. The intervention group will receive eight one hour weekly Mamas in Harmony sessions plus usual care and the control group will receive usual care only. Feasibility measures include recruitment, retention, and attendance at intervention sessions. The process evaluation aims to establish acceptability of the intervention involving survey evaluation and semi-structured interviews. A priori guidelines have been agreed to establish criteria for progression to a definitive RCT. Discussion The current evidence supports the use of music in reducing anxiety and stress with the recommendation for inclusion of social support. This study has potential to provide robust evidence of the feasibility and acceptability of a music and social support mother-infant group intervention in preparation for a future definitive trial, should progression criteria be met. Trial registration ClinicalTrials.gov ID: NCT05930990. Registered retrospectively on 5 July 2023. Recruitment commenced on 16 March 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05930990?term=music+and+social+support&draw=2&rank=1 Protocol version 30/10/2023 Vn 1.0 Music Anxiety Stress Mothers Infant Postnatal Feasibility Randomized Controlled Trial Figures Figure 1 Figure 2 Figure 3 Background Poor postnatal mental health has the potential to lead to negative outcomes for both mother and child, and is a current leading public health issue with significant economic burden if untreated ( 1 ). Symptoms of low mood, anxiety, stress, and/or feeling isolated may be experienced by around 15–20% of mothers in the first year after childbirth ( 2 ). If left undiagnosed/untreated, symptoms may progress to an anxiety disorder and/or depression ( 3 ). Recent research shows postnatal depression is significantly higher in women six months after giving birth during the Covid 19 pandemic compared to pre-pandemic levels when comparing data from maternity surveys completed in England in 2014, 2018 and 2020 ( 4 ). Studies investigating the effect of poor postnatal mental health have found an adverse impact on mother-infant attachment ( 5 ), bonding, self-regulation and empathy ( 6 ). Consequently, mothers may find it difficult to engage with their infants both emotionally and behaviourally resulting in reducing their physical contact ( 7 ). Provision by the mother of a less stimulating environment, being less attuned to their infant ( 8 ) and feelings of reduced competence in the mother ( 9 ) have also been reported. The postnatal period is considered by National Institute for Health and Care Excellence (NICE) to last for 1 year after the birth of the child ( 10 ). Prevalence of an anxiety disorder across pregnancy and the postnatal period has been estimated to be 20.7% ( 11 ), however the literature remains less established and less understood for postnatal anxiety compared to postnatal depression ( 12 ). Despite screening, postnatal mental health problems often go unidentified, undiagnosed, and untreated for many women or they do not meet the eligibility threshold for specialist mental health services after the birth of their baby ( 13 ). Women may fear stigma and negative perceptions if they disclose a mental health problem in pregnancy or the postnatal period ( 13 ). Current pharmacological treatment options offered by health professionals involved in the care of mothers often have potential for side effects and low uptake and adherence, especially for breastfeeding mothers ( 14 ). Psychotherapy has presented challenges with mixed results of effect, and short-lived improvements ( 15 ); ( 16 ). The economic cost of poor mental health for mothers has also been considered. The NHS Long term Plan ( 10 ) identified that perinatal (pregnancy and postnatal period combined) anxiety costs approximately £35,000 per case, of which £14,000 relates to the impact on the child. Therefore introducing low-cost, non-pharmacological interventions that target anxiety and provide social support to mothers may be worthwhile and potentially cost saving for the NHS, families and society as a whole. The field of arts in health is rapidly expanding with evidence from research into arts-based initiatives in primary and secondary health care. The findings of seven experimental studies synthesised within a systematic review have shown a variety of benefits of singing among 327 participants living with mental health conditions. Participants across the UK and Australia demonstrated improvements in depression, quality of life, and mental wellbeing following singing interventions lasting at least 8 weeks ( 17 ). Six qualitative studies further indicated that group singing resulted in a sense of belonging, improved self-confidence and were considered enjoyable ( 17 ). A recent systematic review assessed the effect of mother-infant group music sessions (any type of music as the primary component) on maternal postnatal depression ( 18 ). The review identified two studies conducted in the UK and in Australia, both measuring maternal depression following 10-weekly music sessions for the intervention group compared to no intervention for the control group ( 19 , 20 ). No clear theoretical underpinnings were detailed within either study. Results did not show a significant reduction in depression post-intervention for those allocated to the intervention group compared with the control. No statistical difference was found in total parenting stress scores post intervention between groups ( 20 ). However, secondary outcomes were statistically significantly different, with anxiety and stress reduced and maternal self-efficacy improved in the intervention group when compared to control post intervention ( 18 ). Findings from this review suggested a potential for music-based mother-infant group interventions to improve maternal anxiety, stress and self-efficacy. Qualitative research conducted alongside one of the studies showed mothers found singing facilitated social cohesion ( 21 ). A subsequent process evaluation ( 22 ) of this singing intervention found postnatal mothers recommended the opportunity for coffee after each session to allow for socialising with other mothers ( 22 ). Further recommendations from the studies was a larger space so mothers had room to leave the immediate circle of the activity if required ( 22 ), and a shorter format from the 10 week duration due to only 44% of participants attending ≥ 5 sessions ( 20 ). Rationale In the context of the available evidence, a music-based group intervention for mother-infant dyads may have the potential to reduce symptoms of anxiety and stress, promote social support and target an improvement in the mother-infant relationship ( 23 ). This study will seek to test a novel mother-infant group intervention that combines music and social support in a feasibility study with a pilot randomised controlled trial, in order to provide a foundation from which a protocol for a definitive RCT could be developed. The feasibility of a full economic evaluation will also be evaluated to establish best methods for collecting data and a process evaluation completed to understand the mothers and intervention facilitator/s experiences of the intervention. The SPIRIT 2013 Statement recommendations have guided the creation of this protocol ( 24 ), in conjunction with additional guidance from the CONSORT extension to pilot and feasibility trials ( 25 ) to ensure transparency and quality of reporting. Objectives for pilot RCT : Conduct pilot RCT of a music based intervention (Mamas in Harmony) alongside usual care versus usual care only to establish the feasibility of a definitive RCT in terms of recruitment rate, retention rate, adherence to the intervention, and completion rates of outcome measures Assess feasibility of conducting a full economic evaluation, in terms of completion rates of data collection tools and assess promise of cost-effectiveness Use data obtained to assist with review and adjustment of the protocol, intervention and creation of a logic model Methods Trial design The pilot RCT is a parallel two group study design and an economic evaluation. Block randomisation will be carried out on a 2:1 allocation. A process evaluation will be conducted alongside consisting of a survey and semi-structured interviews. Study setting The pilot RCT will be carried out in Belfast, a city in Northern Ireland. The intervention setting is a community venue in Belfast and will be a single study site. Pilot RCT Eligibility criteria The focus of this study is not on effect size and so, a power calculation has not been estimated. Participants for the pilot RCT will be mothers who are aged 16 or over, who have a baby ≥ 14 days to ≤ 4 months of age at time of consent will be invited to participate. They must be able and willing to provide consent, as identified by having a satisfactory understanding of English and comprehension of the participant information sheet and consent form. Women will not be able to enter the study if they have given birth in the last 14 days, their infant is > 4 months of age at time of consent and/or have identified as not having satisfactory understanding of English and comprehension of the participant information sheet and consent form. Mothers who have received a diagnosis of, or being treated for, severe mental illness including Bipolar disorder, Psychoses or Schizophrenia within the past 6 months (discovered through self-report at time of eligibility screening) will also be excluded. This is due to the existing evidence supporting the use of singing interventions for symptoms of postnatal anxiety and stress ( 20 ) and not as a treatment for severe mental health conditions. Recruitment The recruitment strategy to identify and approach potential participants will involve posts on social media, emailing via contact lists of relevant local community organisations, and displaying of recruitment posters on communal/public facing noticeboards. Recruitment material will contain an email contact for the researcher and QR code, which when scanned, directs potential participants to the study webpage containing an introduction to the study, a participant information sheet and online contact form. Mothers who express interest in participating will be contacted by the researcher and screened for eligibility. If eligible, they will be invited to participate, informed and, if interested will provide informed consent, obtained by the researcher (CC). Recruitment will last approximately 1 year. A recruitment flow diagram has been created for the pilot RCT (Fig. 1). Figure 1. Recruitment flow diagram – Pilot RCT Randomisation Following informed consent and baseline data collection, participants will be randomly allocated to the intervention group receiving Mamas in Harmony and usual care or the control group receiving usual care alone. Usual care consists of postnatal care offered by Health and Social Care (HSC) services in Northern Ireland provided by the mother’s community midwife, GP and health visitor. Usual care comprises of mother and infant health and wellbeing checks, infant weighing, infant feeding advice and support, developmental assessments and additional visits based on need and capacity ( 26 ). The sequence generation for randomisation of study participants will be carried out in blocks of 6 with a 2:1 allocation to the intervention and control group using a computer-generated random allocation sequence on Randomization.com ( http://www.randomization.com ). Randomisation will be completed by a member of the research team (FL) who is not involved in the recruitment process to ensure allocation concealment from participants and the researcher recruiting individuals (CC). Owing to the nature of the intervention, it is not possible to blind participants or personnel delivering the intervention to group status following randomisation. As all outcomes will be self-reported by the mother, it will not be possible to blind outcome assessors to group status either. Intervention The Mamas in Harmony intervention is underpinned by three key theoretical concepts: (i) the biopsychosocial model of health; (ii) self-determination theory; and (iii) the psychology of flow. The intervention consists of music and social support delivered during 1 hour face to face sessions each week for 8 consecutive weeks and is based on a group music activity for mother-infant dyads developed by Una McCann, a singer, songwriter and instrumentalist who currently runs community choirs with up to 200 adults per week in attendance. Her prior experience involves 8 years working with children for the Junior Academy of Music in Northern Ireland as a choir leader and music tutor. The music component of the intervention has been previously tested and delivered to mothers and infants at SureStart facilities across Northern Ireland enabling further development for the current intervention. Following a systematic review of evidence of music interventions ( 18 ), which highlighted mothers recommendation for coffee after each session to allow for socialising with other mothers; a social support component was added to the intervention, the duration of sessions set at 8 weeks and a venue chosen which allows mothers space to break away from the immediate circle of activity if required. Approximately 10–12 mothers allocated to the intervention group will attend the same community venue where the sessions will take place each week with their babies. The intervention involves mothers attending a group setting in a room each week with their babies. They will be invited to sit on upon soft cushioned play mats in a circle formation with their babies lying on blankets in front of them. Small, colourful, age and developmentally appropriate toys and sensory objects will be available for baby to look at and touch. The singing component will last 40 minutes and begin with welcoming each mother and infant to the group. The facilitator then introduces a mix of songs that are easy to learn and pleasing to listen to without the need for lyric sheets. Mothers will be encouraged to join in singing, feel connected to each other through the song and will involve some gentle bouncing/rocking movements with baby. Mothers will be encouraged to interact with their baby through various sensory stimuli involving touch, sound and visual, for example, tickling fingers, gentle massage and humming sounds close to their baby’s ear. The group session will end with a social support component, with mothers encouraged to stay for refreshments and informal facilitated social support, where conversation with and between mothers will be initiated and supported by the intervention facilitator and assistant. Mothers will be encouraged to interact with other mothers to promote social connection. The TIDieR checklist ( 24 ) was used to aid reporting of the intervention. A strategy to improve adherence to the intervention protocol will be a text message reminder for attendance the day before each weekly session. Feasibility measures The primary measure is rates of recruitment and retention using screening logs. Secondary feasibility measures are rate of adherence of participants across each stage of the pilot RCT using study registers, with reasons for non-attendance if disclosed. Also rate of attendance to intervention sessions, with reasons for non-attendance if disclosed. Completion rate of outcome measurement tools including Generalised Anxiety Disorder – 7 scale (GAD-7), Edinburgh Postnatal Depression Scale (EPDS), Perceived Stress Scale (PSS), Karitane Parenting Confidence Scale (KPCS), Social Support Survey (SSS), Maternal Postnatal Attachment Scale (MPAS), EuroQol EQ-5D-5L, and service and resource use log will also be collected. The GAD-7 was developed to assist health professionals in detecting generalised anxiety. While not specific to postnatal mothers, the GAD-7 scale is currently recommended by NICE ( 2 ). There are no validated tools to aid diagnosis specifically of postnatal anxiety ( 12 ). The GAD-7 consists of 7 questions with a choice of 4 responses based on how the individual has felt over the past 2 weeks which is measured on a scale of 0–21. Scores of 5, 10 and 15 are taken as the cut off points for mild, moderate and severe anxiety respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater ( 27 ). The EPDS was developed to assist health professionals in detecting postnatal depression. The scale consists of 10 questions with a choice of 4 responses based on how the individual has felt over the past 7 days and is measured on a scale of 0–30. A score of more than 10 suggests depression may be present and further evaluation is recommended ( 28 ). The PSS was developed to assist in assessing stress level in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month, consisting of 10 questions. The PSS score is obtained by summing across all items. Higher scores indicate higher levels of perceived stress. There are no published score cut-offs as this is not a diagnostic instrument ( 29 ). The KPCS was developed to assist in the support and development of parenting skills for parents of children 0–12 months of age and contains 15 items with scores of 0–45. Parents scoring 39 or less may be experiencing low levels of parenting confidence ( 30 ). The SSS consists of 19 questions across 4 separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support ( 31 ). The MPAS was developed to assess the mothers emotional response to her infant along a number of dimensions relating to parent-infant attachment and has 19 items with the number of response categories varying between two and five. Item totals are summed to obtain the scale score. Lower scores indicate lower attachment and vice versa ( 32 ). The EuroQol EQ-5D-5L asks respondents rate their health-related quality of life today on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) in order to assess treatment effects and investigate gains (or losses) in reported health status ( 33 ). A service and resource use instrument developed and used previously by the research team (FL, JM) for a similar population will be used in this study to capture and cost public sector service and resource use for postnatal mothers. All tools will be administered to assess whether it is an appropriate outcome measure for a full scale trial, as determined by completion rate and proportion of missing data. Sample size A total sample size of 60 mother/infant dyads has been chosen, with 40 mother-infant dyads randomly allocated to the intervention group and 20 mother-infant dyads randomly allocated to the control group. Between 10–12 mother-infant dyads will participate in a Mamas in Harmony group at a time and then repeated 3–4 times to reach the required sample size receiving the intervention. Process evaluation The process evaluation will seek to understand perspectives on barriers and facilitators to study participation (intervention/control group) and to explore expectations of and satisfaction with the intervention (intervention group). It will also seek to understand perspectives on barriers and facilitators to intervention delivery to determine improvements needed for future research. Finally the process evaluation will enable understanding of the perspectives on implementation in terms of fidelity (intervention delivered as intended). Participants Participants for the survey evaluation will be mothers who participated in the study and were part of the intervention group. Participants for the semi-structured interviews will be mothers who participated in the study and were part of the intervention group or control group, and who expressed interest in participating at baseline and intervention facilitator/s who delivered at least one Mamas in Harmony session. Recruitment All mothers allocated to the intervention group who attend the final Mamas in Harmony session will be invited to complete a survey evaluation of the intervention. Survey evaluation will take place at the community venue in which intervention delivery took place. Selection Mothers who indicated an interest in taking part in an interview will have their study ID entered into a MS Excel file where a random number generator will be used to compile a random list of all the study IDs. It is anticipated that 12 (20%) of participants will indicate they will be interested in an interview and that on invite, eight of these will agree, provide consent and be interviewed. In the first instance, the mothers of the first eight randomly generated study IDs will be approached by the researcher through the participant’s preferred mode of contact, informed of this component of the study and invited to participate. Recruitment will continue, by contacting the mother assigned to sequential Study IDs on the list, until 8 interviews have been completed. The intervention facilitator/s will be invited to participate in an interview following completion of all intervention sessions. Semi-structured interviews will take place online, via Microsoft Teams or face to face as preferred. Acceptability measures The measures used for the process evaluation include exploring expectations of and satisfaction with the intervention and ideas for improvement using evaluation forms. These will be administered to mothers in week 8 at the final session of the intervention. The evaluation form will include a number of questions with possible responses on a scale of 0–10, a higher score indicating a better rating, scale of strongly disagree to strongly agree, scale of very unlikely to very likely, multiple choice questions and free text answer boxes. The evaluation form will also enable insight on the acceptability of the intervention in terms of being liked or disliked, appropriate, benefits gained, to identify any barriers to attendance and/or engagement that exist and recommendations for improvement. This information will then provide further prompts alongside the interview schedule created for use with a subset of study participants. The schedule for enrolment, delivery of intervention and assessment of outcomes for both the pilot RCT and process evaluation has been created and illustrated in a Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram in conjunction with additional guidance from the CONSORT extension to pilot and feasibility trials ( 25 ) can be found in Fig. 2. Figure 2. SPIRIT diagram illustrating the schedule of enrolment, implementation of interventions and timeline of assessments Data collection Recruitment, retention, attendance and adherence data will be collected using screening logs and study registers. Outcome assessment tools including GAD-7, EPDS, PSS, KPCS, SSS, MPAS and EuroQol EQ-5D-5L will be collected online using Qualtrics survey platform or via a paper copy as preferred. Service and resource use logs will be completed in paper form. An email reminder will be sent after 2 weeks to encourage retention and completion of follow up measures. This will be followed by a second and final email reminder after a further 2 weeks if still no response. A £15 retail gift card will be provided to all participants on completion of the pilot RCT at 6 months. Evaluation forms will be distributed to participants allocated to the intervention group in week 8 at the final session of the intervention. They will be informed that they do not have to complete the form if they do not wish to, and that the forms are anonymous. Semi structured interviews were chosen as the preference over focus groups for participants and an outline interview schedule has been created. Interviews will enable more flexibility in relation to planning and identification of a day and time suitable to individual participants. Socio-demographic characteristics, including marital status, ethnic group, highest educational attainment and household income of participants will be collected at the start of the interview to establish a profile of the participants taking part in the interviews. While interviews are more time consuming than focus groups for the researcher, they are more convenient to the mother and allow confidentiality for the mother in the discussion and so anticipated to be more likely to have higher participation rates. Interviews are further anticipated to provide rich data in relation to the depth of understanding gained of the mothers’ experiences ( 34 ). Interviews will be conducted and recorded online via Microsoft Teams or face to face as preferred. For intervention facilitator/s who are approached, informed, invited to participate and who consent, a semi-structured interview will be conducted and recorded upon completion of all cycles of sessions. This will allow them to provide their professional opinion on barriers and facilitators to intervention delivery to determine improvements needed for future research and to understand perspectives on implementation in terms of fidelity (intervention delivered as intended), to inform future research. These will also be conducted and recorded online or face to face as preferred. Interview schedules for both mothers and intervention facilitator/s have been developed and were informed by current evidence. Questions will also focus on the facilitators/barriers to participation in the intervention and research study to inform future research. See Fig. 3. Figure 3. Examples of interview questions Data management All data will be handled in line with General Data Protection Regulation (GPDR) and other relevant regulations ( 35 ). Data collected online via Qualtrics, Microsoft Teams interview recordings or MP4 audio interview recordings will be saved on an encrypted hard drive approved by the research institution and ethics committee. Data collected in paper form will be stored in a lockable filing cabinet behind a locked door on University premises. Only members of the research team will have access to the data. Data analysis For the pilot RCT and surveys within the process evaluation, continuous data will be presented as means and standard deviations and categorical data presented as frequencies and percentages, focusing primarily on rates of recruitment, retention, adherence, attendance, completion of each measurement tool and proportion of missing data. While means and standard deviations will be presented for each outcome measure, the study is not statistically powered to establish effect; therefore, summary scores will not be used for hypothesis testing. Recruitment, participation and retention rates will be reported and presented in a CONSORT flow diagram ( 36 ). Participants who drop out versus retained at 8 weeks (immediately post intervention) and participants who drop out versus retained at 26 weeks (post randomisation) will be reported on in terms of maternal characteristics at baseline for the intervention and control group. For the process evaluation, audio recordings from the interviews will be transcribed verbatim by the researcher and pseudonymised transcripts will be uploaded to NVivo and analysed using an interpretive qualitative approach based on the principles of thematic analysis ( 37 ). This type of analysis focuses on identifying themes throughout the data and then be coded by identifying persistent words, phrases, experiences or concepts. Data will then be grouped according to topic, allowing further identification of sub-themes. Following coding, the data will be categorised to reflect the overall picture of the data and relationships between categories. Related categories will be merged into themes ( 34 ). Reflexivity will be practiced throughout the conduct of the pilot RCT including analysis, and individual analysis will be conducted by the research team, then discussion and agreement. Therefore allowing the researcher to aim to understand perspectives from the point of view of the participant. This allows any biases or assumptions about the content to be examined and for the researchers to undergo a process of self-examination ( 38 ). These themes will be used to gain an understanding of the perspectives of mothers and intervention facilitator/s participating in the study. A data monitoring committee will be established for the full RCT but is not required for the feasibility work proposed. No significant physical risks are expected to be associated with the participation in this study. A health and safety assessment of the venue for its suitability for mother and infant classes will be conducted prior to commencement of the study and on an ongoing basis during the study. The risk of psychological harm is expected to be minimal. Previous research using a similar intervention has shown no adverse events to study participants ( 19 ). The intervention facilitator and assistant facilitator will be vigilant during delivery of the intervention, process evaluation interviews and during any other contacts with study participants for any sign of distress observed or verbalised by the mother. If this occurs, the researcher will take appropriate action as set out in the distress protocols for both the Mamas in Harmony sessions and interviews. It is acknowledged that outcome data provided at post intervention and follow up timepoints by mothers during the study would not normally be analysed until completion. However, due to completion of outcome measurement tools for anxiety and depression (GAD-7 and EPDS) having the potential to identify scores above the recognised clinical threshold for the tool representing significant symptoms and/or risk to the mother and infant, these data will be analysed by the researcher within one week of receipt of the completed questionnaire from the mother. This will enable the researcher to signpost the mother to her GP and other appropriate supports as per the distress protocol. Once follow-up is complete and participants have exited the study, the control group will be offered one Mamas in Harmony session to enable them to have experience of the intervention. Progression to definitive RCT Due to the nature of the study, it is not powered to test hypotheses related to the effect of the intervention in comparison to usual care. Instead, it has been designed to support development and assess feasibility of conducting a future definitive RCT ( 25 ). For progression to a definitive RCT, the following a priori guidelines will be used: Mother/infant dyads are recruited within a 6 week timeframe; Mamas in Harmony classes have a minimum of 10 mother/infant dyads allocated to each group of classes in the recruitment timeframe; rate of attendance in Mamas in Harmony classes is ≥ 70%; rate of retention of mothers at T2 follow-up is ≥ 80% and the proportion of missing data in each completed questionnaire is ≤ 10%. Dissemination The protocol has been completed as part of a PhD study conducted within the School of Nursing and Midwifery at Queens University, Belfast, Northern Ireland. Findings will be disseminated via academic audiences, relevant stakeholders and service users and social media. Discussion To our knowledge, this study is the first of its kind to investigate the feasibility of a face to face group community-based intervention comprising music and social support for postnatal mothers and their infants. By offering this combined intervention to mothers in the early postnatal period in a group setting, we hope to establish its feasibility for a full scale trial and promise of effect on outcomes including anxiety and stress. Acknowledging the known effect of poor postnatal mental health on mother-infant attachment and the desired addition of a social opportunity expressed by mothers in a previous process evaluation of a music intervention ( 22 ), it is intended that Mamas in Harmony will provide an accessible, supportive and calming environment for mothers to thrive. Abbreviations RCT Randomised controlled trial HSC Health and Social Care GAD-7 Generalised anxiety disorder scale 7 EPDS Edinburgh postnatal depression scale PSS Perceived stress scale KPCS Karitane parenting confidence scale SSS Social support survey MPAS Maternal postnatal attachment scale QUB Queen’s University Belfast Declarations Ethics approval and consent to participate Ethical approval has been granted from the Faculty of Medicine, Health and Life Sciences Research Ethics Committee at Queen’s University Belfast (QUB) prior to commencing the study (MHLS 22_168). Any protocol amendments will be submitted to the Research Ethics Committee at Queen’s University Belfast (QUB) for approval. Consent for publication Not applicable Availability of data and materials Not applicable, the manuscript does not contain any data. Competing interests The authors have declared that no competing interests exist. Funding The author(s) received no specific funding for this work. Author’s contributions The author (CC) is a current PhD student at Queen’s University Belfast in Northern Ireland and will be undertaking this feasibility study as part of their PhD study, while FL and JM are members of their supervisory team. All authors have contributed to the conception and design of this protocol. CC drafted the initial protocol with FL, JM and UM providing editorial input. All authors have read and agreed this final version of the protocol. Acknowledgements We would like to thank Una McCann for providing knowledge and expertise on the development of the Mamas in Harmony intervention. We are also grateful to our project advisory group; Dr Alison McKinlay, Fiona Dixon and Carly McCann whose role is to provide advice on intervention development, recruitment strategy, and interpretation and dissemination of findings. Trial sponsor Queen’s University Belfast Author information Corinna Colella [email protected] Dr Jenny McNeill [email protected] Una McCann [email protected] Dr Fiona Lynn [email protected] Appendices Consent forms SPIRIT checklist References Dennis C-L, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: Systematic review and meta-analysis. British Journal of Psychiatry. 2017;210(5):315-23. NICE. Antenatal and postnatal mental health: clinical management and service guidance: NICE; 2020 [Available from: https://www.nice.org.uk/guidance/cg192/chapter/recommendations#anxiety-disorders. (RCOG) RCoOaG. Management of Women with Mental Health Issues during Pregnancy and the Postnatal Period. 2011. Harrison S, Quigley MA, Fellmeth G, Stein A, Alderdice F. The impact of the Covid-19 pandemic on postnatal depression: analysis of three population-based national maternity surveys in England (2014–2020). The Lancet Regional Health - Europe. 2023;30:100654. 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Maternity and mental health: NICE; 2022 [Available from: https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-use-of-nice-guidance/impact-of-our-guidance/niceimpact-maternity/ch2-maternity-and-mental-health. Fawcett EJ, Fairbrother N, Cox ML, White IR, Fawcett JM. The prevalence of anxiety disorders during pregnancy and the postpartum period: a multivariate Bayesian meta-analysis. The Journal of clinical psychiatry. 2019;80(4):1181. Silverwood VA, Bullock L, Turner K, Chew-Graham CA, Kingstone T. The approach to managing perinatal anxiety: A mini-review. Frontiers in Psychiatry. 2022;13:1022459. Coates R, de Visser R, Ayers S. Not identifying with postnatal depression: a qualitative study of women's postnatal symptoms of distress and need for support. J Psychosom Obstet Gynaecol. 2015;36(3):114-21. Yang W-j, Bai Y-m, Qin L, Xu X-l, Bao K-f, Xiao J-l, et al. The effectiveness of music therapy for postpartum depression: A systematic review and meta-analysis. Complementary Therapies in Clinical Practice. 2019;37:93-101. Morrell CJ, Warner R, Slade P, Dixon S, Walters S, Paley G, et al. Psychological interventions for postnatal depression: cluster randomised trial and economic evaluation. The PoNDER trial. Health Technol Assess. 2009;13(30):1-153. Cooper PJ, Murray L, Wilson A, Romaniuk H. Controlled trial of the short- and long-term effect of psychological treatment of post-partum depression: I. Impact on maternal mood. British Journal of Psychiatry. 2003;182(5):412-9. Williams E, Dingle GA, Clift S. A systematic review of mental health and wellbeing outcomes of group singing for adults with a mental health condition. European journal of public health. 2018;28(6):1035-42. Colella C, Lynn F, McNeill J. The effect of mother-infant group music interventions on postnatal depression – a systematic review. 2021. Fancourt D, Perkins R. Effect of singing interventions on symptoms of postnatal depression: Three-arm randomised controlled trial. British Journal of Psychiatry. 2018;212(2):119-21. Ericksen J, Loughlin E, Holt C, Rose N, Hartley E, Buultjens M, et al. A THERAPEUTIC PLAYGROUP FOR DEPRESSED MOTHERS AND THEIR INFANTS: FEASIBILITY STUDY AND PILOT RANDOMIZED TRIAL OF COMMUNITY HUGS. Infant Ment Health J. 2018;39(4):396-409. Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychology. 2018;6(1):41. Fancourt D, Perkins R. Creative interventions for symptoms of postnatal depression: a process evaluation of implementation. Arts & Health. 2019;11(1):38-53. Estevao C, Bind R, Fancourt D, Sawyer K, Dazzan P, Sevdalis N, et al. SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression. BMJ Open. 2021;11(11):e052133. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Bmj. 2016;355. DHSSPS. Healthy Child, Health Future. A Framework for the Universal Child Health Promotion Programme in Northern Ireland. 2010. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine. 2006;166(10):1092-7. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782-6. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. 1983:385-96. Črnčec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Research in Nursing & Health. 2008;31(5):442-53. Sherbourne CD, Stewart AL. The MOS social support survey. Social Science & Medicine. 1991;32(6):705-14. Condon JT, Corkindale CJ. The assessment of parent-to-infant attachment: Development of a self-report questionnaire instrument. Journal of Reproductive and Infant Psychology. 1998;16(1):57-76. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-36. Green J, Thorogood N. Qualitative Methods for Health Research. 4th ed. London: SAGE; 2018. QUB. Data Protection: Queen's University Belfast; 2023 [Available from: https://www.qub.ac.uk/about/Leadership-and-structure/Registrars-Office/Information-Compliance-Unit/Data-Protection/. Schulz KF, Altman DG, Moher D, the CG. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11(1):32. Braun V, Clarke V, Terry G, Rohleder P, Lyons A. Qualitative research in clinical and health psychology. London, England: Palgrave Macmillan; 2014. Campbell KA, Orr E, Durepos P, Nguyen L, Li L, Whitmore C, et al. Reflexive thematic analysis for applied qualitative health research. The Qualitative Report. 2021;26(6):2011-28. Supplementary Files Appendix1Consentforms.docx Appendix2SPIRITchecklist.docx.doc Cite Share Download PDF Status: Published Journal Publication published 10 Apr, 2025 Read the published version in Pilot and Feasibility Studies → Version 1 posted Editorial decision: Minor revision 21 Jan, 2025 Reviewers agreed at journal 30 Apr, 2024 Reviewers invited by journal 28 Apr, 2024 Editor assigned by journal 01 Dec, 2023 First submitted to journal 06 Nov, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3574802","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":296427534,"identity":"50a64edc-146b-4aa3-8a6b-0cdbe21864d2","order_by":0,"name":"Corinna Colella","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3klEQVRIiWNgGAWjYHACxgMMBRYMbMzMBxgYG8AizAT1HGAwkGDgZ2dLIFGLZD+PAXFa+NsPHzjwwUBC3uAwz8fbvDsY5PkbeIwN8GmROJOWcHCGgYThhsO8m615zzAYzjjAY5yAT4uBBA/QfAMJRqCWbdK8bQyMGxh4jA8Q1PLHQMJ+w2GeZyAt9sRpAZKJM5t52EBaEkFa8DoM7JceA4nkfmY2Y8u5ZySSZxxmK8brfWCIHXzwo8LGto3/8MMbb3fY2Pa3N2+WwKcF1UowIhyRqFpGwSgYBaNgFGACABNKQcDnkkFEAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-6212-5250","institution":"Queen's University Belfast Faculty of Medicine Health and Life Sciences","correspondingAuthor":true,"prefix":"","firstName":"Corinna","middleName":"","lastName":"Colella","suffix":""},{"id":296427535,"identity":"e3263400-b73c-41c6-9f58-99e6ba061297","order_by":1,"name":"Jenny McNeill","email":"","orcid":"","institution":"Queen's University Belfast","correspondingAuthor":false,"prefix":"","firstName":"Jenny","middleName":"","lastName":"McNeill","suffix":""},{"id":296427536,"identity":"91ae7fd9-0e90-4ad0-a15e-981e351f7449","order_by":2,"name":"Una McCann","email":"","orcid":"","institution":"Queen's University Belfast","correspondingAuthor":false,"prefix":"","firstName":"Una","middleName":"","lastName":"McCann","suffix":""},{"id":296427537,"identity":"41eff75a-4313-4a1d-944d-9af854843b2a","order_by":3,"name":"Fiona A. Lynn","email":"","orcid":"","institution":"Queen's University Belfast","correspondingAuthor":false,"prefix":"","firstName":"Fiona","middleName":"A.","lastName":"Lynn","suffix":""}],"badges":[],"createdAt":"2023-11-07 14:20:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3574802/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3574802/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-025-01629-1","type":"published","date":"2025-04-10T16:05:11+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":55808773,"identity":"5f42003f-6cbd-44fe-b080-c1230082b066","added_by":"auto","created_at":"2024-05-03 15:36:17","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":159909,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eRecruitment flow diagram – Pilot RCT\u003c/em\u003e\u003c/p\u003e","description":"","filename":"Figure1RecruitmentflowdiagrampilotRCT.png","url":"https://assets-eu.researchsquare.com/files/rs-3574802/v1/f37532c9c21e0ff3827d0429.png"},{"id":55808776,"identity":"863a738f-b1f9-4a74-8395-b95988a86855","added_by":"auto","created_at":"2024-05-03 15:36:17","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":143111,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eSPIRIT diagram illustrating the schedule of enrolment, implementation of interventions and timeline of assessments\u003c/em\u003e\u003c/p\u003e","description":"","filename":"Figure2SPIRITdiagram.png","url":"https://assets-eu.researchsquare.com/files/rs-3574802/v1/6d505c952a9b326b47897c77.png"},{"id":55808772,"identity":"4c0e70d2-ca48-43f9-bc6f-62c1b9e1442e","added_by":"auto","created_at":"2024-05-03 15:36:17","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":237290,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eExamples of interview questions\u003c/em\u003e\u003c/p\u003e","description":"","filename":"Figure3Examplesofinterviewquestions.png","url":"https://assets-eu.researchsquare.com/files/rs-3574802/v1/15c72e545e8b310189393b77.png"},{"id":80559057,"identity":"59406799-257e-4af6-b384-5e5bd6c2260a","added_by":"auto","created_at":"2025-04-14 16:17:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1208760,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3574802/v1/9c7a279d-7d08-446b-bfbb-e393fdab5779.pdf"},{"id":55810308,"identity":"6462db81-b3b2-4fad-b274-8e76e12199ac","added_by":"auto","created_at":"2024-05-03 15:52:17","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":121830,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1Consentforms.docx","url":"https://assets-eu.researchsquare.com/files/rs-3574802/v1/0f783bcfd6e370082da6b0b1.docx"},{"id":55809872,"identity":"65367e08-f0f2-4646-a284-8aa98758abd3","added_by":"auto","created_at":"2024-05-03 15:44:17","extension":"doc","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":125952,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix2SPIRITchecklist.docx.doc","url":"https://assets-eu.researchsquare.com/files/rs-3574802/v1/e424f2bdc9db8bf40b91a7e1.doc"}],"financialInterests":"","formattedTitle":"Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers","fulltext":[{"header":"Background","content":"\u003cp\u003ePoor postnatal mental health has the potential to lead to negative outcomes for both mother and child, and is a current leading public health issue with significant economic burden if untreated (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Symptoms of low mood, anxiety, stress, and/or feeling isolated may be experienced by around 15\u0026ndash;20% of mothers in the first year after childbirth (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). If left undiagnosed/untreated, symptoms may progress to an anxiety disorder and/or depression (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Recent research shows postnatal depression is significantly higher in women six months after giving birth during the Covid 19 pandemic compared to pre-pandemic levels when comparing data from maternity surveys completed in England in 2014, 2018 and 2020 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eStudies investigating the effect of poor postnatal mental health have found an adverse impact on mother-infant attachment (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e), bonding, self-regulation and empathy (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Consequently, mothers may find it difficult to engage with their infants both emotionally and behaviourally resulting in reducing their physical contact (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Provision by the mother of a less stimulating environment, being less attuned to their infant (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) and feelings of reduced competence in the mother (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) have also been reported.\u003c/p\u003e \u003cp\u003eThe postnatal period is considered by National Institute for Health and Care Excellence (NICE) to last for 1 year after the birth of the child (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Prevalence of an anxiety disorder across pregnancy and the postnatal period has been estimated to be 20.7% (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), however the literature remains less established and less understood for postnatal anxiety compared to postnatal depression (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Despite screening, postnatal mental health problems often go unidentified, undiagnosed, and untreated for many women or they do not meet the eligibility threshold for specialist mental health services after the birth of their baby (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Women may fear stigma and negative perceptions if they disclose a mental health problem in pregnancy or the postnatal period (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Current pharmacological treatment options offered by health professionals involved in the care of mothers often have potential for side effects and low uptake and adherence, especially for breastfeeding mothers (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Psychotherapy has presented challenges with mixed results of effect, and short-lived improvements (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e); (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe economic cost of poor mental health for mothers has also been considered. The NHS Long term Plan (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) identified that perinatal (pregnancy and postnatal period combined) anxiety costs approximately \u0026pound;35,000 per case, of which \u0026pound;14,000 relates to the impact on the child. Therefore introducing low-cost, non-pharmacological interventions that target anxiety and provide social support to mothers may be worthwhile and potentially cost saving for the NHS, families and society as a whole.\u003c/p\u003e \u003cp\u003eThe field of arts in health is rapidly expanding with evidence from research into arts-based initiatives in primary and secondary health care. The findings of seven experimental studies synthesised within a systematic review have shown a variety of benefits of singing among 327 participants living with mental health conditions. Participants across the UK and Australia demonstrated improvements in depression, quality of life, and mental wellbeing following singing interventions lasting at least 8 weeks (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Six qualitative studies further indicated that group singing resulted in a sense of belonging, improved self-confidence and were considered enjoyable (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA recent systematic review assessed the effect of mother-infant group music sessions (any type of music as the primary component) on maternal postnatal depression (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). The review identified two studies conducted in the UK and in Australia, both measuring maternal depression following 10-weekly music sessions for the intervention group compared to no intervention for the control group (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). No clear theoretical underpinnings were detailed within either study. Results did not show a significant reduction in depression post-intervention for those allocated to the intervention group compared with the control. No statistical difference was found in total parenting stress scores post intervention between groups (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). However, secondary outcomes were statistically significantly different, with anxiety and stress reduced and maternal self-efficacy improved in the intervention group when compared to control post intervention (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Findings from this review suggested a potential for music-based mother-infant group interventions to improve maternal anxiety, stress and self-efficacy. Qualitative research conducted alongside one of the studies showed mothers found singing facilitated social cohesion (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). A subsequent process evaluation (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) of this singing intervention found postnatal mothers recommended the opportunity for coffee after each session to allow for socialising with other mothers (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). Further recommendations from the studies was a larger space so mothers had room to leave the immediate circle of the activity if required (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), and a shorter format from the 10 week duration due to only 44% of participants attending\u0026thinsp;\u0026ge;\u0026thinsp;5 sessions (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003eRationale\u003c/h2\u003e \u003cp\u003eIn the context of the available evidence, a music-based group intervention for mother-infant dyads may have the potential to reduce symptoms of anxiety and stress, promote social support and target an improvement in the mother-infant relationship (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). This study will seek to test a novel mother-infant group intervention that combines music and social support in a feasibility study with a pilot randomised controlled trial, in order to provide a foundation from which a protocol for a definitive RCT could be developed. The feasibility of a full economic evaluation will also be evaluated to establish best methods for collecting data and a process evaluation completed to understand the mothers and intervention facilitator/s experiences of the intervention. The SPIRIT 2013 Statement recommendations have guided the creation of this protocol (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e), in conjunction with additional guidance from the CONSORT extension to pilot and feasibility trials (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) to ensure transparency and quality of reporting.\u003c/p\u003e \u003cp\u003e \u003cb\u003eObjectives for pilot RCT\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eConduct pilot RCT of a music based intervention (Mamas in Harmony) alongside usual care versus usual care only to establish the feasibility of a definitive RCT in terms of recruitment rate, retention rate, adherence to the intervention, and completion rates of outcome measures\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAssess feasibility of conducting a full economic evaluation, in terms of completion rates of data collection tools and assess promise of cost-effectiveness\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eUse data obtained to assist with review and adjustment of the protocol, intervention and creation of a logic model\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eTrial design\u003c/h2\u003e \u003cp\u003eThe pilot RCT is a parallel two group study design and an economic evaluation. Block randomisation will be carried out on a 2:1 allocation. A process evaluation will be conducted alongside consisting of a survey and semi-structured interviews.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy setting\u003c/h2\u003e \u003cp\u003eThe pilot RCT will be carried out in Belfast, a city in Northern Ireland. The intervention setting is a community venue in Belfast and will be a single study site.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003ePilot RCT\u003c/h2\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eEligibility criteria\u003c/h2\u003e \u003cp\u003eThe focus of this study is not on effect size and so, a power calculation has not been estimated. Participants for the pilot RCT will be mothers who are aged 16 or over, who have a baby\u0026thinsp;\u0026ge;\u0026thinsp;14 days to \u0026le;\u0026thinsp;4 months of age at time of consent will be invited to participate. They must be able and willing to provide consent, as identified by having a satisfactory understanding of English and comprehension of the participant information sheet and consent form. Women will not be able to enter the study if they have given birth in the last 14 days, their infant is \u0026gt;\u0026thinsp;4 months of age at time of consent and/or have identified as not having satisfactory understanding of English and comprehension of the participant information sheet and consent form. Mothers who have received a diagnosis of, or being treated for, severe mental illness including Bipolar disorder, Psychoses or Schizophrenia within the past 6 months (discovered through self-report at time of eligibility screening) will also be excluded. This is due to the existing evidence supporting the use of singing interventions for symptoms of postnatal anxiety and stress (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) and not as a treatment for severe mental health conditions.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment\u003c/h2\u003e \u003cp\u003eThe recruitment strategy to identify and approach potential participants will involve posts on social media, emailing via contact lists of relevant local community organisations, and displaying of recruitment posters on communal/public facing noticeboards. Recruitment material will contain an email contact for the researcher and QR code, which when scanned, directs potential participants to the study webpage containing an introduction to the study, a participant information sheet and online contact form. Mothers who express interest in participating will be contacted by the researcher and screened for eligibility. If eligible, they will be invited to participate, informed and, if interested will provide informed consent, obtained by the researcher (CC). Recruitment will last approximately 1 year. A recruitment flow diagram has been created for the pilot RCT (Fig.\u0026nbsp;1).\u003c/p\u003e \u003cp\u003e \u003cem\u003eFigure 1. Recruitment flow diagram \u0026ndash; Pilot RCT\u003c/em\u003e \u003c/p\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003eRandomisation\u003c/h2\u003e \u003cp\u003eFollowing informed consent and baseline data collection, participants will be randomly allocated to the intervention group receiving Mamas in Harmony and usual care or the control group receiving usual care alone. Usual care consists of postnatal care offered by Health and Social Care (HSC) services in Northern Ireland provided by the mother\u0026rsquo;s community midwife, GP and health visitor. Usual care comprises of mother and infant health and wellbeing checks, infant weighing, infant feeding advice and support, developmental assessments and additional visits based on need and capacity (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe sequence generation for randomisation of study participants will be carried out in blocks of 6 with a 2:1 allocation to the intervention and control group using a computer-generated random allocation sequence on Randomization.com (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.randomization.com\u003c/span\u003e\u003cspan address=\"http://www.randomization.com\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e). Randomisation will be completed by a member of the research team (FL) who is not involved in the recruitment process to ensure allocation concealment from participants and the researcher recruiting individuals (CC).\u003c/p\u003e \u003cp\u003eOwing to the nature of the intervention, it is not possible to blind participants or personnel delivering the intervention to group status following randomisation. As all outcomes will be self-reported by the mother, it will not be possible to blind outcome assessors to group status either.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eIntervention\u003c/h2\u003e \u003cp\u003eThe Mamas in Harmony intervention is underpinned by three key theoretical concepts: (i) the biopsychosocial model of health; (ii) self-determination theory; and (iii) the psychology of flow. The intervention consists of music and social support delivered during 1 hour face to face sessions each week for 8 consecutive weeks and is based on a group music activity for mother-infant dyads developed by Una McCann, a singer, songwriter and instrumentalist who currently runs community choirs with up to 200 adults per week in attendance. Her prior experience involves 8 years working with children for the Junior Academy of Music in Northern Ireland as a choir leader and music tutor. The music component of the intervention has been previously tested and delivered to mothers and infants at SureStart facilities across Northern Ireland enabling further development for the current intervention. Following a systematic review of evidence of music interventions (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), which highlighted mothers recommendation for coffee after each session to allow for socialising with other mothers; a social support component was added to the intervention, the duration of sessions set at 8 weeks and a venue chosen which allows mothers space to break away from the immediate circle of activity if required. Approximately 10\u0026ndash;12 mothers allocated to the intervention group will attend the same community venue where the sessions will take place each week with their babies. The intervention involves mothers attending a group setting in a room each week with their babies. They will be invited to sit on upon soft cushioned play mats in a circle formation with their babies lying on blankets in front of them. Small, colourful, age and developmentally appropriate toys and sensory objects will be available for baby to look at and touch. The singing component will last 40 minutes and begin with welcoming each mother and infant to the group. The facilitator then introduces a mix of songs that are easy to learn and pleasing to listen to without the need for lyric sheets. Mothers will be encouraged to join in singing, feel connected to each other through the song and will involve some gentle bouncing/rocking movements with baby. Mothers will be encouraged to interact with their baby through various sensory stimuli involving touch, sound and visual, for example, tickling fingers, gentle massage and humming sounds close to their baby\u0026rsquo;s ear. The group session will end with a social support component, with mothers encouraged to stay for refreshments and informal facilitated social support, where conversation with and between mothers will be initiated and supported by the intervention facilitator and assistant. Mothers will be encouraged to interact with other mothers to promote social connection. The TIDieR checklist (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) was used to aid reporting of the intervention.\u003c/p\u003e \u003cp\u003eA strategy to improve adherence to the intervention protocol will be a text message reminder for attendance the day before each weekly session.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eFeasibility measures\u003c/h2\u003e \u003cp\u003eThe primary measure is rates of recruitment and retention using screening logs. Secondary feasibility measures are rate of adherence of participants across each stage of the pilot RCT using study registers, with reasons for non-attendance if disclosed. Also rate of attendance to intervention sessions, with reasons for non-attendance if disclosed. Completion rate of outcome measurement tools including Generalised Anxiety Disorder \u0026ndash; 7 scale (GAD-7), Edinburgh Postnatal Depression Scale (EPDS), Perceived Stress Scale (PSS), Karitane Parenting Confidence Scale (KPCS), Social Support Survey (SSS), Maternal Postnatal Attachment Scale (MPAS), EuroQol EQ-5D-5L, and service and resource use log will also be collected.\u003c/p\u003e \u003cp\u003eThe GAD-7 was developed to assist health professionals in detecting generalised anxiety. While not specific to postnatal mothers, the GAD-7 scale is currently recommended by NICE (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). There are no validated tools to aid diagnosis specifically of postnatal anxiety (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). The GAD-7 consists of 7 questions with a choice of 4 responses based on how the individual has felt over the past 2 weeks which is measured on a scale of 0\u0026ndash;21. Scores of 5, 10 and 15 are taken as the cut off points for mild, moderate and severe anxiety respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). The EPDS was developed to assist health professionals in detecting postnatal depression. The scale consists of 10 questions with a choice of 4 responses based on how the individual has felt over the past 7 days and is measured on a scale of 0\u0026ndash;30. A score of more than 10 suggests depression may be present and further evaluation is recommended (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). The PSS was developed to assist in assessing stress level in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month, consisting of 10 questions. The PSS score is obtained by summing across all items. Higher scores indicate higher levels of perceived stress. There are no published score cut-offs as this is not a diagnostic instrument (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). The KPCS was developed to assist in the support and development of parenting skills for parents of children 0\u0026ndash;12 months of age and contains 15 items with scores of 0\u0026ndash;45. Parents scoring 39 or less may be experiencing low levels of parenting confidence (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). The SSS consists of 19 questions across 4 separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). The MPAS was developed to assess the mothers emotional response to her infant along a number of dimensions relating to parent-infant attachment and has 19 items with the number of response categories varying between two and five. Item totals are summed to obtain the scale score. Lower scores indicate lower attachment and vice versa (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). The EuroQol EQ-5D-5L asks respondents rate their health-related quality of life today on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) in order to assess treatment effects and investigate gains (or losses) in reported health status (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). A service and resource use instrument developed and used previously by the research team (FL, JM) for a similar population will be used in this study to capture and cost public sector service and resource use for postnatal mothers. All tools will be administered to assess whether it is an appropriate outcome measure for a full scale trial, as determined by completion rate and proportion of missing data.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSample size\u003c/h2\u003e \u003cp\u003eA total sample size of 60 mother/infant dyads has been chosen, with 40 mother-infant dyads randomly allocated to the intervention group and 20 mother-infant dyads randomly allocated to the control group. Between 10\u0026ndash;12 mother-infant dyads will participate in a Mamas in Harmony group at a time and then repeated 3\u0026ndash;4 times to reach the required sample size receiving the intervention.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eProcess evaluation\u003c/h2\u003e \u003cp\u003eThe process evaluation will seek to understand perspectives on barriers and facilitators to study participation (intervention/control group) and to explore expectations of and satisfaction with the intervention (intervention group). It will also seek to understand perspectives on barriers and facilitators to intervention delivery to determine improvements needed for future research. Finally the process evaluation will enable understanding of the perspectives on implementation in terms of fidelity (intervention delivered as intended).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eParticipants for the survey evaluation will be mothers who participated in the study and were part of the intervention group. Participants for the semi-structured interviews will be mothers who participated in the study and were part of the intervention group or control group, and who expressed interest in participating at baseline and intervention facilitator/s who delivered at least one Mamas in Harmony session.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment\u003c/h2\u003e \u003cp\u003eAll mothers allocated to the intervention group who attend the final Mamas in Harmony session will be invited to complete a survey evaluation of the intervention. Survey evaluation will take place at the community venue in which intervention delivery took place.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eSelection\u003c/h2\u003e \u003cp\u003eMothers who indicated an interest in taking part in an interview will have their study ID entered into a MS Excel file where a random number generator will be used to compile a random list of all the study IDs. It is anticipated that 12 (20%) of participants will indicate they will be interested in an interview and that on invite, eight of these will agree, provide consent and be interviewed. In the first instance, the mothers of the first eight randomly generated study IDs will be approached by the researcher through the participant\u0026rsquo;s preferred mode of contact, informed of this component of the study and invited to participate. Recruitment will continue, by contacting the mother assigned to sequential Study IDs on the list, until 8 interviews have been completed. The intervention facilitator/s will be invited to participate in an interview following completion of all intervention sessions. Semi-structured interviews will take place online, via Microsoft Teams or face to face as preferred.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eAcceptability measures\u003c/h2\u003e \u003cp\u003eThe measures used for the process evaluation include exploring expectations of and satisfaction with the intervention and ideas for improvement using evaluation forms. These will be administered to mothers in week 8 at the final session of the intervention. The evaluation form will include a number of questions with possible responses on a scale of 0\u0026ndash;10, a higher score indicating a better rating, scale of strongly disagree to strongly agree, scale of very unlikely to very likely, multiple choice questions and free text answer boxes. The evaluation form will also enable insight on the acceptability of the intervention in terms of being liked or disliked, appropriate, benefits gained, to identify any barriers to attendance and/or engagement that exist and recommendations for improvement. This information will then provide further prompts alongside the interview schedule created for use with a subset of study participants.\u003c/p\u003e \u003cp\u003eThe schedule for enrolment, delivery of intervention and assessment of outcomes for both the pilot RCT and process evaluation has been created and illustrated in a Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram in conjunction with additional guidance from the CONSORT extension to pilot and feasibility trials (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) can be found in Fig.\u0026nbsp;2.\u003c/p\u003e \u003cp\u003e \u003cem\u003eFigure 2. SPIRIT diagram illustrating the schedule of enrolment, implementation of interventions and timeline of assessments\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eRecruitment, retention, attendance and adherence data will be collected using screening logs and study registers. Outcome assessment tools including GAD-7, EPDS, PSS, KPCS, SSS, MPAS and EuroQol EQ-5D-5L will be collected online using Qualtrics survey platform or via a paper copy as preferred. Service and resource use logs will be completed in paper form.\u003c/p\u003e \u003cp\u003eAn email reminder will be sent after 2 weeks to encourage retention and completion of follow up measures. This will be followed by a second and final email reminder after a further 2 weeks if still no response. A \u0026pound;15 retail gift card will be provided to all participants on completion of the pilot RCT at 6 months.\u003c/p\u003e \u003cp\u003eEvaluation forms will be distributed to participants allocated to the intervention group in week 8 at the final session of the intervention. They will be informed that they do not have to complete the form if they do not wish to, and that the forms are anonymous.\u003c/p\u003e \u003cp\u003e Semi structured interviews were chosen as the preference over focus groups for participants and an outline interview schedule has been created. Interviews will enable more flexibility in relation to planning and identification of a day and time suitable to individual participants. Socio-demographic characteristics, including marital status, ethnic group, highest educational attainment and household income of participants will be collected at the start of the interview to establish a profile of the participants taking part in the interviews.\u003c/p\u003e \u003cp\u003eWhile interviews are more time consuming than focus groups for the researcher, they are more convenient to the mother and allow confidentiality for the mother in the discussion and so anticipated to be more likely to have higher participation rates. Interviews are further anticipated to provide rich data in relation to the depth of understanding gained of the mothers\u0026rsquo; experiences (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). Interviews will be conducted and recorded online via Microsoft Teams or face to face as preferred.\u003c/p\u003e \u003cp\u003eFor intervention facilitator/s who are approached, informed, invited to participate and who consent, a semi-structured interview will be conducted and recorded upon completion of all cycles of sessions. This will allow them to provide their professional opinion on barriers and facilitators to intervention delivery to determine improvements needed for future research and to understand perspectives on implementation in terms of fidelity (intervention delivered as intended), to inform future research. These will also be conducted and recorded online or face to face as preferred.\u003c/p\u003e \u003cp\u003eInterview schedules for both mothers and intervention facilitator/s have been developed and were informed by current evidence. Questions will also focus on the facilitators/barriers to participation in the intervention and research study to inform future research. See Fig.\u0026nbsp;3.\u003c/p\u003e \u003cp\u003e \u003cem\u003eFigure 3. Examples of interview questions\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eData management\u003c/h2\u003e \u003cp\u003eAll data will be handled in line with General Data Protection Regulation (GPDR) and other relevant regulations (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). Data collected online via Qualtrics, Microsoft Teams interview recordings or MP4 audio interview recordings will be saved on an encrypted hard drive approved by the research institution and ethics committee. Data collected in paper form will be stored in a lockable filing cabinet behind a locked door on University premises. Only members of the research team will have access to the data.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eFor the pilot RCT and surveys within the process evaluation, continuous data will be presented as means and standard deviations and categorical data presented as frequencies and percentages, focusing primarily on rates of recruitment, retention, adherence, attendance, completion of each measurement tool and proportion of missing data. While means and standard deviations will be presented for each outcome measure, the study is not statistically powered to establish effect; therefore, summary scores will not be used for hypothesis testing. Recruitment, participation and retention rates will be reported and presented in a CONSORT flow diagram (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). Participants who drop out versus retained at 8 weeks (immediately post intervention) and participants who drop out versus retained at 26 weeks (post randomisation) will be reported on in terms of maternal characteristics at baseline for the intervention and control group.\u003c/p\u003e \u003cp\u003eFor the process evaluation, audio recordings from the interviews will be transcribed verbatim by the researcher and pseudonymised transcripts will be uploaded to NVivo and analysed using an interpretive qualitative approach based on the principles of thematic analysis (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). This type of analysis focuses on identifying themes throughout the data and then be coded by identifying persistent words, phrases, experiences or concepts. Data will then be grouped according to topic, allowing further identification of sub-themes. Following coding, the data will be categorised to reflect the overall picture of the data and relationships between categories. Related categories will be merged into themes (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). Reflexivity will be practiced throughout the conduct of the pilot RCT including analysis, and individual analysis will be conducted by the research team, then discussion and agreement. Therefore allowing the researcher to aim to understand perspectives from the point of view of the participant. This allows any biases or assumptions about the content to be examined and for the researchers to undergo a process of self-examination (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e). These themes will be used to gain an understanding of the perspectives of mothers and intervention facilitator/s participating in the study.\u003c/p\u003e \u003cp\u003eA data monitoring committee will be established for the full RCT but is not required for the feasibility work proposed.\u003c/p\u003e \u003cp\u003eNo significant physical risks are expected to be associated with the participation in this study. A health and safety assessment of the venue for its suitability for mother and infant classes will be conducted prior to commencement of the study and on an ongoing basis during the study. The risk of psychological harm is expected to be minimal. Previous research using a similar intervention has shown no adverse events to study participants (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The intervention facilitator and assistant facilitator will be vigilant during delivery of the intervention, process evaluation interviews and during any other contacts with study participants for any sign of distress observed or verbalised by the mother. If this occurs, the researcher will take appropriate action as set out in the distress protocols for both the Mamas in Harmony sessions and interviews.\u003c/p\u003e \u003cp\u003eIt is acknowledged that outcome data provided at post intervention and follow up timepoints by mothers during the study would not normally be analysed until completion. However, due to completion of outcome measurement tools for anxiety and depression (GAD-7 and EPDS) having the potential to identify scores above the recognised clinical threshold for the tool representing significant symptoms and/or risk to the mother and infant, these data will be analysed by the researcher within one week of receipt of the completed questionnaire from the mother. This will enable the researcher to signpost the mother to her GP and other appropriate supports as per the distress protocol.\u003c/p\u003e \u003cp\u003eOnce follow-up is complete and participants have exited the study, the control group will be offered one Mamas in Harmony session to enable them to have experience of the intervention.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eProgression to definitive RCT\u003c/h2\u003e \u003cp\u003eDue to the nature of the study, it is not powered to test hypotheses related to the effect of the intervention in comparison to usual care. Instead, it has been designed to support development and assess feasibility of conducting a future definitive RCT (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). For progression to a definitive RCT, the following a priori guidelines will be used: Mother/infant dyads are recruited within a 6 week timeframe; Mamas in Harmony classes have a minimum of 10 mother/infant dyads allocated to each group of classes in the recruitment timeframe; rate of attendance in Mamas in Harmony classes is \u0026ge;\u0026thinsp;70%; rate of retention of mothers at T2 follow-up is \u0026ge;\u0026thinsp;80% and the proportion of missing data in each completed questionnaire is \u0026le;\u0026thinsp;10%.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eDissemination\u003c/h2\u003e \u003cp\u003eThe protocol has been completed as part of a PhD study conducted within the School of Nursing and Midwifery at Queens University, Belfast, Northern Ireland. Findings will be disseminated via academic audiences, relevant stakeholders and service users and social media.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo our knowledge, this study is the first of its kind to investigate the feasibility of a face to face group community-based intervention comprising music and social support for postnatal mothers and their infants. By offering this combined intervention to mothers in the early postnatal period in a group setting, we hope to establish its feasibility for a full scale trial and promise of effect on outcomes including anxiety and stress. Acknowledging the known effect of poor postnatal mental health on mother-infant attachment and the desired addition of a social opportunity expressed by mothers in a previous process evaluation of a music intervention (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), it is intended that Mamas in Harmony will provide an accessible, supportive and calming environment for mothers to thrive.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eRCT Randomised controlled trial\u003c/p\u003e\n\u003cp\u003eHSC Health and Social Care\u003c/p\u003e\n\u003cp\u003eGAD-7 Generalised anxiety disorder scale 7\u003c/p\u003e\n\u003cp\u003eEPDS Edinburgh postnatal depression scale\u003c/p\u003e\n\u003cp\u003ePSS Perceived stress scale\u003c/p\u003e\n\u003cp\u003eKPCS Karitane parenting confidence scale\u003c/p\u003e\n\u003cp\u003eSSS Social support survey\u003c/p\u003e\n\u003cp\u003eMPAS Maternal postnatal attachment scale\u003c/p\u003e\n\u003cp\u003eQUB Queen\u0026rsquo;s University Belfast\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval has been granted from the\u0026nbsp;Faculty of Medicine, Health and Life Sciences Research Ethics Committee at Queen\u0026rsquo;s University Belfast (QUB) prior to commencing the study (MHLS 22_168).\u0026nbsp;Any protocol amendments will be submitted to\u0026nbsp;the Research Ethics Committee at Queen\u0026rsquo;s University Belfast (QUB) for approval.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable, the manuscript does not contain any data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have declared that no competing interests exist.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author(s) received no specific funding for this work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor\u0026rsquo;s contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author (CC) is a current PhD student at Queen\u0026rsquo;s University Belfast in Northern Ireland and will be undertaking this feasibility study as part of their PhD study, while FL and JM are members of their supervisory team. All authors have contributed to the conception and design of this protocol. CC drafted the initial protocol with FL, JM and UM providing editorial input. All authors have read and agreed this final version of the protocol.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank Una McCann for providing knowledge and expertise on the development of the Mamas in Harmony intervention. We are also grateful to our project advisory group; Dr Alison McKinlay, Fiona Dixon and Carly McCann whose role is to provide advice on intervention development, recruitment strategy, and interpretation and dissemination of findings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial sponsor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eQueen\u0026rsquo;s University Belfast\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCorinna Colella \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;[email protected]\u003c/p\u003e\n\u003cp\u003eDr Jenny McNeill \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;[email protected]\u003c/p\u003e\n\u003cp\u003eUna McCann \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;[email protected]\u003c/p\u003e\n\u003cp\u003eDr Fiona Lynn \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; [email protected]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAppendices\u003c/strong\u003e\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eConsent forms\u003c/li\u003e\n \u003cli\u003eSPIRIT checklist\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eDennis C-L, Falah-Hassani K, Shiri R. 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J Child Psychol Psychiatry. 2006;47(7):660-9.\u003c/li\u003e\n\u003cli\u003eRossen L, Hutchinson D, Wilson J, Burns L, C AO, Allsop S, et al. Predictors of postnatal mother-infant bonding: the role of antenatal bonding, maternal substance use and mental health. Arch Women Ment Health. 2016;19(4):609-22.\u003c/li\u003e\n\u003cli\u003eHolt C, Gentilleau C, Gemmill AW, Milgrom J. Improving the mother-infant relationship following postnatal depression: a randomised controlled trial of a brief intervention (HUGS). Arch Women Ment Health. 2021;19:19.\u003c/li\u003e\n\u003cli\u003eBrummelte S, Galea LA. Postpartum depression: Etiology, treatment and consequences for maternal care. Horm Behav. 2016;77:153-66.\u003c/li\u003e\n\u003cli\u003eBeebe B, Steele M, Jaffe J, Buck KA, Chen H, Cohen P, et al. Maternal Anxiety Symptoms and Mother-Infant Self- and Interactive Contingency. Infant Ment Health J. 2011;32(2):174-206.\u003c/li\u003e\n\u003cli\u003eNICE. 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How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychology. 2018;6(1):41.\u003c/li\u003e\n\u003cli\u003eFancourt D, Perkins R. Creative interventions for symptoms of postnatal depression: a process evaluation of implementation. Arts \u0026amp; Health. 2019;11(1):38-53.\u003c/li\u003e\n\u003cli\u003eEstevao C, Bind R, Fancourt D, Sawyer K, Dazzan P, Sevdalis N, et al. SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression. BMJ Open. 2021;11(11):e052133.\u003c/li\u003e\n\u003cli\u003eChan AW, Tetzlaff JM, Altman DG, Laupacis A, G\u0026oslash;tzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7.\u003c/li\u003e\n\u003cli\u003eEldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Bmj. 2016;355.\u003c/li\u003e\n\u003cli\u003eDHSSPS. Healthy Child, Health Future. A Framework for the Universal Child Health Promotion Programme in Northern Ireland. 2010.\u003c/li\u003e\n\u003cli\u003eSpitzer RL, Kroenke K, Williams JB, L\u0026ouml;we B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine. 2006;166(10):1092-7.\u003c/li\u003e\n\u003cli\u003eCox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782-6.\u003c/li\u003e\n\u003cli\u003eCohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. 1983:385-96.\u003c/li\u003e\n\u003cli\u003eČrnčec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Research in Nursing \u0026amp; Health. 2008;31(5):442-53.\u003c/li\u003e\n\u003cli\u003eSherbourne CD, Stewart AL. The MOS social support survey. Social Science \u0026amp; Medicine. 1991;32(6):705-14.\u003c/li\u003e\n\u003cli\u003eCondon JT, Corkindale CJ. The assessment of parent-to-infant attachment: Development of a self-report questionnaire instrument. Journal of Reproductive and Infant Psychology. 1998;16(1):57-76.\u003c/li\u003e\n\u003cli\u003eHerdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-36.\u003c/li\u003e\n\u003cli\u003eGreen J, Thorogood N. Qualitative Methods for Health Research. 4th ed. London: SAGE; 2018.\u003c/li\u003e\n\u003cli\u003eQUB. Data Protection: Queen\u0026apos;s University Belfast; 2023 [Available from: https://www.qub.ac.uk/about/Leadership-and-structure/Registrars-Office/Information-Compliance-Unit/Data-Protection/.\u003c/li\u003e\n\u003cli\u003eSchulz KF, Altman DG, Moher D, the CG. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11(1):32.\u003c/li\u003e\n\u003cli\u003eBraun V, Clarke V, Terry G, Rohleder P, Lyons A. Qualitative research in clinical and health psychology. London, England: Palgrave Macmillan; 2014.\u003c/li\u003e\n\u003cli\u003eCampbell KA, Orr E, Durepos P, Nguyen L, Li L, Whitmore C, et al. Reflexive thematic analysis for applied qualitative health research. The Qualitative Report. 2021;26(6):2011-28.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Music, Anxiety, Stress, Mothers, Infant, Postnatal, Feasibility, Randomized Controlled Trial","lastPublishedDoi":"10.21203/rs.3.rs-3574802/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3574802/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePostnatal mothers can experience anxiety, stress, and difficulty with mother-infant attachment with potential to lead to an anxiety disorder/depression. There has been an increase in interest in non-pharmacological interventions involving music, with limited evidence assessing effectiveness in this population within randomised controlled trials (RCTs). Mamas in Harmony is a novel music/social support intervention. The objective is to assess the feasibility/acceptability of conducting a full RCT to test the effect and cost-effectiveness of Mamas in Harmony compared with usual care.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe pilot RCT aims to recruit 60 mother-infant dyads through social media, community organisations and stakeholder networks, randomly allocated on a 2:1 ratio to the intervention and control group. The intervention group will receive eight one hour weekly Mamas in Harmony sessions plus usual care and the control group will receive usual care only. Feasibility measures include recruitment, retention, and attendance at intervention sessions. The process evaluation aims to establish acceptability of the intervention involving survey evaluation and semi-structured interviews. A priori guidelines have been agreed to establish criteria for progression to a definitive RCT.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe current evidence supports the use of music in reducing anxiety and stress with the recommendation for inclusion of social support. This study has potential to provide robust evidence of the feasibility and acceptability of a music and social support mother-infant group intervention in preparation for a future definitive trial, should progression criteria be met.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eClinicalTrials.gov ID: NCT05930990. Registered retrospectively on 5 July 2023. Recruitment commenced on 16 March 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05930990?term=music+and+social+support\u0026amp;draw=2\u0026amp;rank=1\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProtocol version\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e30/10/2023 Vn 1.0\u003c/p\u003e","manuscriptTitle":"Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-03 15:36:12","doi":"10.21203/rs.3.rs-3574802/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2025-01-21T09:26:37+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-04-30T16:08:37+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-28T19:21:56+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-12-01T10:26:23+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2023-11-06T09:30:06+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"528dd888-ba10-42f0-92e8-2d7aed295288","owner":[],"postedDate":"May 3rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-04-14T16:14:25+00:00","versionOfRecord":{"articleIdentity":"rs-3574802","link":"https://doi.org/10.1186/s40814-025-01629-1","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2025-04-10 16:05:11","publishedOnDateReadable":"April 10th, 2025"},"versionCreatedAt":"2024-05-03 15:36:12","video":"","vorDoi":"10.1186/s40814-025-01629-1","vorDoiUrl":"https://doi.org/10.1186/s40814-025-01629-1","workflowStages":[]},"version":"v1","identity":"rs-3574802","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3574802","identity":"rs-3574802","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}