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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">Front. Psychiatry</journal-id>
<journal-title-group>
<journal-title>Frontiers in Psychiatry</journal-title>
<abbrev-journal-title abbrev-type="pubmed">Front. Psychiatry</abbrev-journal-title>
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<issn pub-type="epub">1664-0640</issn>
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<publisher-name>Frontiers Media S.A.</publisher-name>
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<article-id pub-id-type="doi">10.3389/fpsyt.2026.1758640</article-id>
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<article-categories>
<subj-group subj-group-type="heading">
<subject>Methods</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Development and reporting of a specialised antenatal music therapy intervention using the MRC framework and TIDieR checklist</article-title>
</title-group>
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<name><surname>Cheung</surname><given-names>Pui Sze</given-names></name>
<xref ref-type="aff" rid="aff1"><sup>1</sup></xref>
<xref ref-type="aff" rid="aff2"><sup>2</sup></xref>
<xref ref-type="aff" rid="aff3"><sup>3</sup></xref>
<xref ref-type="aff" rid="aff4"><sup>4</sup></xref>
<xref ref-type="corresp" rid="c001"><sup>*</sup></xref>
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<name><surname>Tighe</surname><given-names>Sylvia Murphy</given-names></name>
<xref ref-type="aff" rid="aff1"><sup>1</sup></xref>
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<name><surname>Mohamad</surname><given-names>Mas Mahady</given-names></name>
<xref ref-type="aff" rid="aff2"><sup>2</sup></xref>
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<name><surname>McCaffrey</surname><given-names>Triona</given-names></name>
<xref ref-type="aff" rid="aff1"><sup>1</sup></xref>
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<aff id="aff1"><label>1</label><institution>Health Research Institute, University of Limerick</institution>, <city>Limerick</city>,&#xa0;<country country="ie">Ireland</country></aff>
<aff id="aff2"><label>2</label><institution>Specialist Perinatal Mental Health Service, University Maternity Hospital Limerick</institution>, <city>Limerick</city>,&#xa0;<country country="ie">Ireland</country></aff>
<aff id="aff3"><label>3</label><institution>Irish World Academy of Music and Dance, University of Limerick</institution>, <city>Limerick</city>,&#xa0;<country country="ie">Ireland</country></aff>
<aff id="aff4"><label>4</label><institution>Research Centre for Arts and Wellbeing, Edge Hill University</institution>, <city>Ormskirk</city>,&#xa0;<country country="gb">United Kingdom</country></aff>
<aff id="aff5"><label>5</label><institution>School of Nursing and Midwifery, University of Limerick</institution>, <city>Limerick</city>,&#xa0;<country country="ie">Ireland</country></aff>
<aff id="aff6"><label>6</label><institution>School of Medicine, University of Limerick</institution>, <city>Limerick</city>,&#xa0;<country country="ie">Ireland</country></aff>
<author-notes>
<corresp id="c001"><label>*</label>Correspondence: Pui Sze Cheung, <email xlink:href="mailto:puisze.cheung@ul.ie">puisze.cheung@ul.ie</email></corresp>
</author-notes>
<pub-date publication-format="electronic" date-type="pub" iso-8601-date="2026-02-09">
<day>09</day>
<month>02</month>
<year>2026</year>
</pub-date>
<pub-date publication-format="electronic" date-type="collection">
<year>2026</year>
</pub-date>
<volume>17</volume>
<elocation-id>1758640</elocation-id>
<history>
<date date-type="received">
<day>02</day>
<month>12</month>
<year>2025</year>
</date>
<date date-type="accepted">
<day>23</day>
<month>01</month>
<year>2026</year>
</date>
<date date-type="rev-recd">
<day>21</day>
<month>01</month>
<year>2026</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright &#xa9; 2026 Cheung, Tighe, Mohamad and McCaffrey.</copyright-statement>
<copyright-year>2026</copyright-year>
<copyright-holder>Cheung, Tighe, Mohamad and McCaffrey</copyright-holder>
<license>
<ali:license_ref start_date="2026-02-09">https://creativecommons.org/licenses/by/4.0/</ali:license_ref>
<license-p>This is an open-access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License (CC BY)</ext-link>. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.</license-p>
</license>
</permissions>
<abstract>
<sec>
<title>Introduction</title>
<p>Perinatal mental health can significantly impact parental and infant wellbeing. Music interventions have shown promise in improving perinatal wellbeing during pregnancy. However, research in this area remains scarce, and very few structured music therapy programmes have been developed and reported in sufficient detail to enable replication and implementation in clinical settings. This article aims to describe the development process of a novel Specialised Antenatal Music Therapy (SAMT) intervention and provide a detailed report of this using the Template for Intervention Description and Replication (TIDieR) 12-point checklist.</p>
</sec>
<sec>
<title>Methods</title>
<p>Guided by the Medical Research Council (MRC) framework for developing complex interventions, SAMT was developed through a systematic, evidence-based, theory-driven, and stakeholder-informed process. This included: (1) assembling a multidisciplinary expert team, (2) reviewing existing research evidence and antenatal music therapy protocols, (3) understanding the context and engaging stakeholders through research and co-creation, (4) drawing on existing theories and techniques to facilitate treatment outcomes, and (5) evaluating the feasibility and efficacy through a proof-of-concept study.</p>
</sec>
<sec>
<title>Results</title>
<p>This systematic approach resulted in the development of SAMT - a novel music therapy programme for pregnant women attending a Specialist Perinatal Mental Health Service (SPMHS) in Ireland. SAMT consists of six weekly individual music therapy sessions, each lasting 45&#x2013;60 minutes, delivered either online or in-person at the SPMHS outpatient clinic in a central location. Key components include music-assisted relaxation, identifying a bonding song, musical bonding, song discussion, songwriting, creating pregnancy/birth playlists, and creative music making. Early feasibility testing indicated that the intervention was acceptable and well received by participants.</p>
</sec>
<sec>
<title>Discussion/conclusion</title>
<p>Using the TIDieR checklist to report complex interventions provides a structured, systematic way of conveying necessary detail. This method enables music therapists, clinicians, and researchers to understand the SAMT&#x2019;s underlying rationale, theoretical foundation, delivery methods, and implementation considerations, facilitating replication, refinement, and integration into perinatal mental health services and research.</p>
</sec>
</abstract>
<kwd-group>
<kwd>antenatal music therapy</kwd>
<kwd>intervention development</kwd>
<kwd>perinatal mental health</kwd>
<kwd>TIDieR checklist</kwd>
<kwd>women&#x2019;s health</kwd>
</kwd-group>
<funding-group>
<funding-statement>The author(s) declared that financial support was received for this work and/or its publication. The open access publication fee for this article was supported by the Health Research Institute, University of Limerick.</funding-statement>
</funding-group>
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<custom-meta-group>
<custom-meta>
<meta-name>section-at-acceptance</meta-name>
<meta-value>Psychological Therapy and Psychosomatics</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
<body>
<sec id="s1" sec-type="intro">
<label>1</label>
<title>Introduction</title>
<p>Pregnancy represents a profound life transition, characterised by significant physical, psychological, and social changes, including bodily transformations, hormonal fluctuations, and shifts in identity, relationships, and career roles (<xref ref-type="bibr" rid="B1">1</xref>). Perinatal mental health refers to the psychological and emotional wellbeing of women during pregnancy and the first year after birth. A healthy transition to parenthood requires adapting to changes in ways that foster positive coping strategies, emotional regulation, resilience, meaning-making, and secure attachments with the infant, while preserving a strong sense of identity and agency (<xref ref-type="bibr" rid="B2">2</xref>).</p>
<p>While this period can be transformative and empowering, it may also involve psychological challenges that require sensitive, woman-centred support. Factors such as financial stress, social isolation, relationship difficulties, intimate partner violence, prior mental illness, discontinuation of psychotropic medication, previous pregnancy loss, traumatic birth experiences, and other adverse life events can heighten vulnerability for some women (<xref ref-type="bibr" rid="B1">1</xref>, <xref ref-type="bibr" rid="B3">3</xref>, <xref ref-type="bibr" rid="B4">4</xref>). Research reveals up to 27% of women experience mental health difficulties in early pregnancy, with anxiety and depression being most common (<xref ref-type="bibr" rid="B5">5</xref>). Globally, up to 25% and 17% of pregnant women report symptoms of anxiety (<xref ref-type="bibr" rid="B6">6</xref>) and depression respectively (<xref ref-type="bibr" rid="B7">7</xref>). If left unaddressed, perinatal mental health conditions can increase the risk of postnatal depression and anxiety, impair maternal functioning, and diminish quality of life (<xref ref-type="bibr" rid="B7">7</xref>). They are among the leading causes of maternal mortality, with suicide being the most common direct cause of death during the perinatal period in the UK and Ireland (<xref ref-type="bibr" rid="B5">5</xref>). These conditions are also associated with difficulties in mother-infant bonding, which may affect long-term emotional and behavioural development in children (<xref ref-type="bibr" rid="B8">8</xref>). Systematic reviews show that depression and anxiety during pregnancy significantly increase the risk of adverse birth outcomes, including up to a 140% higher risk of preterm birth and a 60-80% higher risk of low birth weight (<xref ref-type="bibr" rid="B9">9</xref>&#x2013;<xref ref-type="bibr" rid="B12">12</xref>). These outcomes may result from elevated maternal stress hormones, such as cortisol and catecholamines, which affect placental function, foetal growth, and uterine blood flow (<xref ref-type="bibr" rid="B13">13</xref>, <xref ref-type="bibr" rid="B14">14</xref>). Maternal stress during pregnancy has also been shown to influence foetal brain development and is associated with increased risks of neurodevelopmental and health problems in early childhood, including ADHD, ASD, emotional difficulties, cognitive impairments, and asthma (<xref ref-type="bibr" rid="B13">13</xref>, <xref ref-type="bibr" rid="B15">15</xref>, <xref ref-type="bibr" rid="B16">16</xref>), as well as anxiety disorders and internalising behaviours in adolescence (<xref ref-type="bibr" rid="B17">17</xref>, <xref ref-type="bibr" rid="B18">18</xref>).</p>
<p>Perinatal mental health problems impose a significant economic burden, with lifetime costs per annual birth cohort estimated at &#xa3;8.1 billion in the UK (<xref ref-type="bibr" rid="B19">19</xref>), $14.2 billion in the United States (<xref ref-type="bibr" rid="B20">20</xref>), $7.3 billion in Australia (<xref ref-type="bibr" rid="B21">21</xref>), $7.3 billion in Brazil (<xref ref-type="bibr" rid="B22">22</xref>), and $2.8 billion in South Africa (<xref ref-type="bibr" rid="B23">23</xref>). In response, there is a growing emphasis on strategies that nurture women&#x2019;s emotional wellbeing, strengthen their capacity for self-care and resilience during pregnancy, and foster a positive, empowering transition to parenthood (<xref ref-type="bibr" rid="B24">24</xref>).</p>
<p>Music-based interventions have gained recognition as effective non-pharmacological approaches to support emotional regulation, reduce stress, and foster maternal-foetal bonding during pregnancy (<xref ref-type="bibr" rid="B25">25</xref>). These interventions range from passive listening to recorded music to active engagement activities such as lullaby programmes and singing groups (<xref ref-type="bibr" rid="B26">26</xref>). Music therapy is distinct in being delivered by a credentialed therapist within a therapeutic relationship, using personalised and interactive musical experiences tailored to individual needs. This live, responsive process offers a non-invasive and engaging option for promoting emotional well-being and addressing mental health challenges. Its adaptability, low stigma, and non-invasive nature make it an appealing alternative to conventional talk therapy and pharmacological treatments during pregnancy (<xref ref-type="bibr" rid="B27">27</xref>).</p>
<p>To the authors&#x2019; knowledge, there is no published protocols or guidelines specifically tailored for antenatal music therapy aimed at women experiencing mental health conditions. It is crucial to provide substantial information about the theoretical basis, the components and the operational definitions of an intervention to promote fidelity and maximise the likelihood of intervention effectiveness (<xref ref-type="bibr" rid="B28">28</xref>). A comprehensive published description of an intervention can assist researchers, clinicians, and policy makers to replicate or build on research findings and to implement effective, sustainable interventions, thereby reducing research waste (<xref ref-type="bibr" rid="B29">29</xref>). This article aims to describe the development of a novel Specialised Antenatal Music Therapy (SAMT) intervention for pregnant women experiencing mental health conditions, guided by the Medical Research Council (MRC) framework for complex interventions and reported using the Template for Intervention Description and Replication (TIDieR) 12-point checklist (<xref ref-type="bibr" rid="B29">29</xref>) to enhance transparency, optimise impact, and improve accessibility of antenatal music therapy.</p>
</sec>
<sec id="s2">
<label>2</label>
<title>Methods</title>
<p>Guided by the MRC framework for developing and evaluating complex interventions, SAMT was developed through a systematic, evidence-based, theory-driven, and stakeholder-informed process. This included:</p>
<list list-type="order">
<list-item>
<p>assembling a multidisciplinary expert team,</p></list-item>
<list-item>
<p>reviewing existing research evidence and antenatal music therapy protocols,</p></list-item>
<list-item>
<p>understanding the context through a cross-sectional study with stakeholders including expectant and new mothers, their partners, and perinatal healthcare professionals,</p></list-item>
<list-item>
<p>drawing on existing theories and techniques to facilitate treatment outcomes, and</p></list-item>
<list-item>
<p>evaluating the feasibility and efficacy.</p></list-item>
</list>
<p>Each of these steps is discussed in detail in the following sections.</p>
<sec id="s2_1">
<label>2.1</label>
<title>Assembling a multidisciplinary expert team</title>
<p>One of the key actions in intervention development is the formation of a team with relevant expertise (<xref ref-type="bibr" rid="B30">30</xref>). The multidisciplinary research team supporting the development of SAMT comprised two credentialed music therapists (Author 1 &amp; 4) with academic backgrounds in psychology and music alongside extensive clinical practice experience in mental health, one of whom is also an Associate Professor (Author 4) with a strong track-record in participatory health research and music therapy service development. The team also included an Associate Professor of Nursing and Midwifery (Author 2) with clinical practice experience in maternity, and community care in addition to research expertise in perinatal, maternal and child mental health, and the delivery of services to marginalised and socially excluded populations. The final team included a consultant psychiatrist (Author 3) and the clinical lead of the regional perinatal mental health service in Ireland, where the intervention was developed.</p>
<p>The music therapist (Author 1) who led on the development and delivery of the intervention also received international advanced training in specialised perinatal music therapy techniques, including Music Therapy Assisted Childbirth (MTACB), birth music consultation, prenatal music bonding, NICU music therapy, and creative arts birthing designed to support the well-being of families throughout the prenatal, childbirth, and postnatal journey.</p>
<p>International experts in perinatal music therapy were also consulted during the intervention development stage. These included notable music therapists based in the United States and the United Kingdom, who were clinical leads in their position and held extensive experience working with pregnant women and new parents across diverse clinical and cultural contexts. Their contributions helped ensure the intervention was theoretically grounded, culturally sensitive, and clinically relevant.</p>
</sec>
<sec id="s2_2">
<label>2.2</label>
<title>Reviewing existing research evidence and antenatal music therapy protocols</title>
<p>The MRC guidance proposes that the optimal approach to developing interventions is to apply the best available evidence (<xref ref-type="bibr" rid="B31">31</xref>). To inform the development of the intervention, a review of key literature on antenatal music interventions was undertaken, both within and outside the specialist field of music therapy. This included a synthesis of documented approaches to antenatal music therapy, focusing on their structure, delivery, and reported outcomes.</p>
<sec id="s2_2_1">
<label>2.2.1</label>
<title>Research evidence on music and perinatal mental health during pregnancy</title>
<p>A substantial body of evidence indicates that music interventions during pregnancy are associated with a decrease in maternal anxiety (<xref ref-type="bibr" rid="B25">25</xref>). A meta-analysis analysed five studies involving 1261 pregnant women and reported that music interventions significantly reduced levels of maternal anxiety (SMD = -0.21, 95% CI: -0.39 to -0.03) (<xref ref-type="bibr" rid="B32">32</xref>). A similar effect (SMD=-0.42, 95% CI: -0.47 to -0.08) was reported from another meta-analysis of 11 studies with 1482 participants and noted the significant anxiety-reducing effects of music listening at home (<xref ref-type="bibr" rid="B33">33</xref>). Additionally, research indicates that listening to relaxing or preferred music can effectively decrease anxiety in women awaiting amniocentesis (<xref ref-type="bibr" rid="B34">34</xref>) and during transvaginal ultrasound (<xref ref-type="bibr" rid="B35">35</xref>). Besides anxiolytic benefits, music interventions have been shown to reduce blood pressure and pregnancy-induced hypertension (<xref ref-type="bibr" rid="B36">36</xref>), improve sleep quality in pregnant women with disturbed sleep (<xref ref-type="bibr" rid="B37">37</xref>), improve lower back pain and increase quality of life during pregnancy (<xref ref-type="bibr" rid="B38">38</xref>). The specialist practice of music therapy has also been shown to significantly reduce pregnancy-related distress for women with high-risk pregnancy experiencing extended antepartum hospitalisation (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B40">40</xref>).</p>
<p>Evidence also suggests that the positive effect of antenatal music engagement can continue beyond pregnancy. For maternal wellbeing and childbirth experience, a RCT found that music listening during pregnancy was associated with a more positive birth experience, characterised by shorter labour duration, higher likelihood of natural onset of delivery, and reduced need for medication (<xref ref-type="bibr" rid="B41">41</xref>). Postnatally, listening to music and singing during pregnancy were associated with higher levels of postnatal maternal wellbeing and lower symptoms of postnatal depression during the first three months after birth (<xref ref-type="bibr" rid="B42">42</xref>).</p>
<p>In terms of neonatal outcomes, singing lullabies during pregnancy was linked to stronger postnatal attachment between mother and infant, and a decrease in neonatal crying episodes, infantile colic, and nightly awakenings (<xref ref-type="bibr" rid="B43">43</xref>). Infants whose mothers listened to music during pregnancy scored better on the Neonatal Behavioural Assessment Scale (NBAS), indicating enhanced neonatal behaviours (<xref ref-type="bibr" rid="B44">44</xref>). Moreover, antenatal music exposure led to long-term neural effects in infants, suggesting that the benefits of such exposure extend well beyond birth (<xref ref-type="bibr" rid="B45">45</xref>). This is supported by a recent systematic review that found antenatal sound stimulation, including music, can form stimulus-specific memory traces during the foetal period and affect neonatal neural systems (<xref ref-type="bibr" rid="B46">46</xref>). Lastly, a recent study found that antenatal music exposure may facilitate early language processing and acquisition (<xref ref-type="bibr" rid="B47">47</xref>). These findings suggest that antenatal music engagement not only benefits maternal mental health but also has a profound impact on infant development and behaviour, with effects that may persist well into childhood.</p>
</sec>
<sec id="s2_2_2">
<label>2.2.2</label>
<title>An overview of antenatal music therapy practice</title>
<p>A targeted literature search identified 10 records of antenatal music therapy practice in English. This section provides an overview of these specialised interventions, which differ from other music-based intervention by involving a qualified music therapist who uses specific music techniques tailored to the unique needs and experiences of pregnant women, their foetuses, and families within a therapeutic relationship. Of the 10 records, five focused on bedside music therapy (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B40">40</xref>, <xref ref-type="bibr" rid="B48">48</xref>&#x2013;<xref ref-type="bibr" rid="B50">50</xref>), three described group programmes (<xref ref-type="bibr" rid="B51">51</xref>&#x2013;<xref ref-type="bibr" rid="B53">53</xref>), one reported home/family-based therapy (<xref ref-type="bibr" rid="B54">54</xref>), and one addressed perinatal palliative music therapy (<xref ref-type="bibr" rid="B55">55</xref>). These programmes are discussed in detail below and summarised in <xref ref-type="table" rid="T1"><bold>Table&#xa0;1</bold></xref>.</p>
<table-wrap id="T1" position="float">
<label>Table&#xa0;1</label>
<caption>
<p>A synthesis of antenatal music therapy programmes described in the literature.</p>
</caption>
<table frame="hsides">
<thead>
<tr>
<th valign="middle" align="left">Author</th>
<th valign="middle" align="left">Article type</th>
<th valign="middle" align="left">Setting</th>
<th valign="middle" align="left">Duration</th>
<th valign="middle" align="left">Intervention aims</th>
<th valign="middle" align="left">Intervention components</th>
<th valign="middle" align="left">Target group</th>
<th valign="middle" align="left">Outcomes</th>
<th valign="middle" align="left">Country</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="middle" align="left">Winslow (1986) (<xref ref-type="bibr" rid="B50">50</xref>)</td>
<td valign="middle" align="left">Case Study</td>
<td valign="middle" align="left">Hospital-based/<break/>bedside</td>
<td valign="middle" align="left">Individual 20 to 30-min session and group session</td>
<td valign="middle" align="left">To alleviate anxiety regarding pregnancy and labour outcome</td>
<td valign="middle" align="left">Individual: Learning<break/>and practicing of progressive relaxation techniques with music and guided imagery, verbal processing, talking to the foetus<break/>Group: lullabies sing-along and group discussion</td>
<td valign="middle" align="left">Individual: Hospitalised antepartum women<break/>Group: pregnant women and new mothers with their babies</td>
<td valign="middle" align="left">Reduction of anxiety, somatic complaints; increased level of compliance with treatment; increased personal awareness of using music as coping mechanisms</td>
<td valign="middle" align="left">USA</td>
</tr>
<tr>
<td valign="middle" align="left">Federico (2005) (<xref ref-type="bibr" rid="B53">53</xref>)</td>
<td valign="middle" align="left">Conference presentation</td>
<td valign="middle" align="left">Group</td>
<td valign="middle" align="left">Unspecified</td>
<td valign="middle" align="left">To strengthen early parents-baby bonding; to improve pregnancy and birth experience; to improve baby&#x2019;s quality of life</td>
<td valign="middle" align="left">Relaxation through movement, creative visualisation with music, welcoming song, sound bath, vibrational massage, improvisation with musical instruments, prenatal music stimulation</td>
<td valign="middle" align="left">Pregnant women (wide range of conditions)</td>
<td valign="middle" align="left">N/A</td>
<td valign="middle" align="left">Argentina</td>
</tr>
<tr>
<td valign="middle" align="left">Friedman et&#xa0;al. (2010) (<xref ref-type="bibr" rid="B52">52</xref>)</td>
<td valign="middle" align="left">Programme description and evaluation</td>
<td valign="middle" align="left">Group</td>
<td valign="middle" align="left">Weekly 1-hour sessions for 6&#x2013;8 weeks</td>
<td valign="middle" align="left">For mothers to use music for self-expression, coping and inspiration, and calm babies.</td>
<td valign="middle" align="left">Music-assisted relaxation, music listening, lyrics analysis, interactive singing and instrument playing, songwriting, personalisation of precomposed lullabies</td>
<td valign="middle" align="left">Pregnant women and new mothers; teen parents</td>
<td valign="middle" align="left">Mother feeling more relaxed, less anxious, more able to care for their babies, able to use activities at home.</td>
<td valign="middle" align="left">USA</td>
</tr>
<tr>
<td valign="middle" align="left">Bauer et&#xa0;al. (2010) (<xref ref-type="bibr" rid="B40">40</xref>)</td>
<td valign="middle" align="left">RCT</td>
<td valign="middle" align="left">Bedside</td>
<td valign="middle" align="left">One 1-hour session</td>
<td valign="middle" align="left">To alleviate antepartum-related distress</td>
<td valign="middle" align="left">Music-facilitated relaxation, active music listening, songwriting, music for bonding, clinical improvisation</td>
<td valign="middle" align="left">Hospitalised pregnant women</td>
<td valign="middle" align="left">Significant reduction of antepartum distress (ABEII)</td>
<td valign="middle" align="left">USA</td>
</tr>
<tr>
<td valign="middle" align="left">Lander (2017) (<xref ref-type="bibr" rid="B54">54</xref>)</td>
<td valign="middle" align="left">Case study</td>
<td valign="middle" align="left">Family-Based</td>
<td valign="middle" align="left">1&#x2013;4 antenatal and postnatal session</td>
<td valign="middle" align="left">For parents to explore and connect with their unborn child, building resilience and confidence</td>
<td valign="middle" align="left">Using melody, rhythm, and voice to promote awareness of self and the foetus, support bonding, encourage communication between parents and foetus</td>
<td valign="middle" align="left">At risk expectant mothers and fathers (history of addition and other psychosocial needs)</td>
<td valign="middle" align="left">Improved confidence in interaction with babies, increased awareness around positive behaviours and motivation to attend local groups &amp; antenatal appointments</td>
<td valign="middle" align="left">Scotland</td>
</tr>
<tr>
<td valign="middle" align="left">Schreck &amp; Economos (2018) (<xref ref-type="bibr" rid="B55">55</xref>)</td>
<td valign="middle" align="left">Case study</td>
<td valign="middle" align="left">Family-Based Palliative Music Therapy</td>
<td valign="middle" align="left">Unspecified</td>
<td valign="middle" align="left">To provide comfort to the families, create a lasting memory, and help in the bereavement process</td>
<td valign="middle" align="left">Recording heartbeats of foetuses and parents, incorporating into a co-created song</td>
<td valign="middle" align="left">Expecting parents facing terminal diagnosis for their foetus</td>
<td valign="middle" align="left">Strengthened connections with loved ones, creating meaningful shared experiences, serving as a catalyst, support bereavement</td>
<td valign="middle" align="left">USA</td>
</tr>
<tr>
<td valign="middle" align="left">Tecken-berg-Jansson et&#xa0;al. (2019) (<xref ref-type="bibr" rid="B49">49</xref>)</td>
<td valign="middle" align="left">RCT</td>
<td valign="middle" align="left">Bedside</td>
<td valign="middle" align="left">Three daily 30-min sessions for three consecutive days</td>
<td valign="middle" align="left">To relieve stress and anxiety</td>
<td valign="middle" align="left">Vibroacoustic intervention using lyre instruments (a Swedish 7-string pentatonic lyre and German Tao-lyre), varying decibel levels, humming lullabies</td>
<td valign="middle" align="left">Hospitalised pregnant women</td>
<td valign="middle" align="left">An increase in the SD2 measure during music therapy sessions, suggesting relaxation effects</td>
<td valign="middle" align="left">Finland</td>
</tr>
<tr>
<td valign="middle" align="left">Corey et&#xa0;al. (2019) (<xref ref-type="bibr" rid="B48">48</xref>)</td>
<td valign="middle" align="left">Mixed methods retrospect analysis</td>
<td valign="middle" align="left">Bedside</td>
<td valign="middle" align="left">One 30-min session</td>
<td valign="middle" align="left">To alleviate stress and anxiety, provide emotional support</td>
<td valign="middle" align="left">Personal relaxation, receptive music listening, music-assisted relaxation, breath entrainment, humming, toning, guided imagery, mindfulness exercise, body scan, verbal validation and support</td>
<td valign="middle" align="left">Hospitalised antepartum women (including postpartum women and their infants)</td>
<td valign="middle" align="left">High satisfaction, positive effects on relaxation and sense of connection with baby.</td>
<td valign="middle" align="left">USA</td>
</tr>
<tr>
<td valign="middle" align="left">Carvalho et&#xa0;al. (2021) (<xref ref-type="bibr" rid="B51">51</xref>)</td>
<td valign="middle" align="left">Longitudinal<break/>and microanalytic case study</td>
<td valign="middle" align="left">Group</td>
<td valign="middle" align="left">12 weekly 90-minute sessions</td>
<td valign="middle" align="left">To promote prenatal bonding</td>
<td valign="middle" align="left">Group musical improvisation, humming and singing, creating songs using &#x201c;musical parody&#x201d; technique, creating a welcome song with family members</td>
<td valign="middle" align="left">Pregnant women</td>
<td valign="middle" align="left">Foetal motor self-exploration, longer infant vocalisations during prenatal song, increased pitch in maternal singing</td>
<td valign="middle" align="left">Portugal</td>
</tr>
<tr>
<td valign="middle" align="left">Horn et&#xa0;al. (2022) (<xref ref-type="bibr" rid="B39">39</xref>)</td>
<td valign="middle" align="left">Mixed methods</td>
<td valign="middle" align="left">Bedside</td>
<td valign="middle" align="left">One to five 50-min sessions</td>
<td valign="middle" align="left">To improve emotional well-being</td>
<td valign="middle" align="left">Guided relaxation, lyric analysis and discussion, song dedication, songwriting, creative music making</td>
<td valign="middle" align="left">Hospitalised pregnant women (including family sometimes)</td>
<td valign="middle" align="left">Improved connections to family, normalisation of the hospital experience, emotional relief, and new<break/>resources to manage the hospital experience</td>
<td valign="middle" align="left">USA</td>
</tr>
</tbody>
</table>
</table-wrap>
<sec id="s2_2_2_1">
<label>2.2.2.1</label>
<title>Bedside music therapy</title>
<p>Bedside music therapy for hospitalised pregnant women emerged as the most frequently reported type of antenatal music therapy in the literature. This included one case study (<xref ref-type="bibr" rid="B50">50</xref>), two RCTs (<xref ref-type="bibr" rid="B40">40</xref>, <xref ref-type="bibr" rid="B49">49</xref>), and two mixed methods studies (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B48">48</xref>). Winslow&#x2019;s (1986) groundbreaking work documented both group and individual music therapy for pregnant women who were hospitalised due to medically deemed high-risk pregnancies (<xref ref-type="bibr" rid="B50">50</xref>). Individual sessions of 20&#x2013;30 minutes duration, three to four times per week, focussed on teaching and practicing progressive relaxation techniques accompanied by music and guided imagery, verbal processing and open discussion with the foetus. A weekly group session of singing lullabies and children&#x2019;s songs was also offered for pregnant women, new mothers and their babies, providing a space to foster group discussions on experiences of hospitalisation, labour, and care for newborns.</p>
<p>Three studies have described a bedside intervention that incorporated a range of music therapy techniques. These include music-facilitated relaxation, active music listening, songwriting, song discussion, music for bonding and clinical improvisation (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B40">40</xref>, <xref ref-type="bibr" rid="B48">48</xref>). Bauer et&#xa0;al. (<xref ref-type="bibr" rid="B40">40</xref>) and Corey et&#xa0;al. (<xref ref-type="bibr" rid="B48">48</xref>) both focused on single bedside sessions lasting 30&#x2013;60 minutes while in the study of Horn et&#xa0;al. (<xref ref-type="bibr" rid="B39">39</xref>)women received up to five sessions with scope to also include their families if women so wished. Lastly, Teckenberg-Jansson et&#xa0;al. (<xref ref-type="bibr" rid="B49">49</xref>) detailed a specific vibroacoustic intervention for relaxation using two lyres (stringed musical instruments), played at varying decibel levels (ranging from 10 to 35 dB) according to each pregnant woman&#x2019;s level of comfort. During the intervention, the music therapist placed and played the lyres on the participating women&#x2019;s abdomen, legs, and back as they lay comfortably on their bed while being encouraged by the therapist to hum lullabies.</p>
</sec>
<sec id="s2_2_2_2">
<label>2.2.2.2</label>
<title>Group music therapy programme</title>
<p>Three publications identified through the targeted search described group-based antenatal music therapy interventions. These included two programme descriptions - <italic>Focal Music Therapy for Obstetrics (FMTO)</italic> (<xref ref-type="bibr" rid="B53">53</xref>) and <italic>Lullaby 101</italic> (<xref ref-type="bibr" rid="B52">52</xref>) &#x2013; and a case study exploring a woman&#x2019;s experience within a 12-week songwriting music therapy group (<xref ref-type="bibr" rid="B51">51</xref>).</p>
<p><italic>FMTO</italic> was designed to strengthen parents-foetal bonding and improve maternal and infant wellbeing (<xref ref-type="bibr" rid="B53">53</xref>). The programme incorporated techniques such as relaxation through movement, creative visualisation with music, a welcome song, sound bath, vibrational massage, musical improvisation (the spontaneous creation of music on musical instruments), and prenatal music stimulation (using music and sound to stimulate the foetus).</p>
<p><italic>Lullaby 101</italic> was a 6-8-week programme for pregnant women and new mothers with mental health conditions including depression, bipolar disorder, or psychosis (<xref ref-type="bibr" rid="B52">52</xref>). This programme involved techniques such as music-assisted relaxation, music listening, lyrics analysis, interactive singing and instrument playing, songwriting, and personalisation of precomposed lullabies. It adopted a curriculum-based model covering topics such as music use in daily life, lullaby composition, identifying signs of infant distress, and choosing calming music.</p>
<p>Carvalho et&#xa0;al. (<xref ref-type="bibr" rid="B51">51</xref>) conducted a longitudinal, micro-analytic case study of a mother&#x2013;infant dyad, tracking interactions from late pregnancy through three months postpartum of a woman who attended a 12-week songwriting group intervention, where five pregnant women collectively created songs for their unborn infants. The process included group musical improvisation, humming and singing, and composing new songs using a musical parody technique, in which pre-existing lyrics were adapted to make them personally meaningful. The group also co-created a welcome song for each unborn baby, with the option for family members to participate if desired. In the micro-analytic follow-up of the mother-infant dyad at nine days and three months postpartum, it was observed that infant vocalisations were significantly longer when hearing the prenatal song compared with humming or silence, and that the mother adapted her singing by increasing pitch following the infant&#x2019;s vocalisations. These findings suggest that an original prenatal song may foster reciprocal musical attunement and enhance early mother-infant interaction.</p>
</sec>
<sec id="s2_2_2_3">
<label>2.2.2.3</label>
<title>Home/family-based music therapy</title>
<p>Two publications identified through the targeted search described unique family-based music therapy programmes: the <italic>BabySounds</italic> project (<xref ref-type="bibr" rid="B54">54</xref>) and <italic>Heartbeat Recording Palliative Music Therapy</italic> (<xref ref-type="bibr" rid="B55">55</xref>).</p>
<p>The <italic>BabySounds</italic> project was a one-year initiative designed for psychosocially vulnerable first-time expectant and new parents who might have a history of addiction, violence, trauma, and abuse. It was aimed at supporting positive parenting, social and emotional health, and social inclusion, and consisted of up to four home visit sessions with pregnant women and their partners during the antenatal and postnatal period. The process involved using melody, rhythm, and voice to promote awareness of self and the foetus, support bonding, and encourage communication between the parents and their foetus.</p>
<p>Schreck and Economos (<xref ref-type="bibr" rid="B55">55</xref>) described a music therapy approach for expectant parents whose foetus was given a terminal diagnosis. The unique intervention involved capturing internal body sounds such as the heartbeats of the foetus and the parents using Doppler and other recording devices. These recordings were then integrated into a song co-created by the music therapist and the parents. This musical creation served as both a therapeutic outlet and a tangible means for parents and families to process and express grief.</p>
</sec>
<sec id="s2_2_2_4">
<label>2.2.2.4</label>
<title>Pregnancy-related music therapy techniques</title>
<p>In most of these music therapy programmes, a diverse array of music therapy techniques was offered and often employed in combination. Beyond traditional music therapy techniques, specialised techniques have been devised to meet the unique needs of pregnant women. These include creating birthing playlists (<xref ref-type="bibr" rid="B56">56</xref>), singing and personalising lullabies (<xref ref-type="bibr" rid="B52">52</xref>), writing a womb song or a welcome song for the infant (<xref ref-type="bibr" rid="B51">51</xref>, <xref ref-type="bibr" rid="B57">57</xref>), vibroacoustic stimulation through lyre instruments (<xref ref-type="bibr" rid="B49">49</xref>) and composing with the recording of parents&#x2019; and foetal heartbeats (<xref ref-type="bibr" rid="B55">55</xref>, <xref ref-type="bibr" rid="B58">58</xref>).</p>
<p>Qualitative findings from these studies and programme reports reveal that music therapy supported maternal wellbeing by offering a space to relax and process thoughts (<xref ref-type="bibr" rid="B48">48</xref>), providing a medium for emotion processing and release (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B52">52</xref>), normalising and enhancing the hospital experience, and equipping women with new resources (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B48">48</xref>). Beyond the individual level, it also helped foster mother-foetal bonding, connect the family, celebrating life, and create lasting legacies and memories (<xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B54">54</xref>, <xref ref-type="bibr" rid="B55">55</xref>, <xref ref-type="bibr" rid="B57">57</xref>).</p>
</sec>
</sec>
</sec>
<sec id="s2_3">
<label>2.3</label>
<title>Understanding the context and engaging stakeholders through research and co-creation</title>
<p>In line with the MRC Framework for Developing and Evaluating Complex Interventions, the design of SAMT was shaped by a comprehensive understanding of the local context, including service structures, policy frameworks, and stakeholder perspectives. These principles informed the intervention&#x2019;s design to enhance its feasibility, acceptability, and potential for long-term implementation (<xref ref-type="bibr" rid="B30">30</xref>, <xref ref-type="bibr" rid="B31">31</xref>). Additionally, SAMT was co-created and refined with participating pregnant women, ensuring that its content and delivery were meaningful, relevant, and adaptable to their needs and experiences.</p>
<sec id="s2_3_1">
<label>2.3.1</label>
<title>The Irish context</title>
<p>Perinatal mental health challenges in Ireland mirror global trends, with approximately one in five women experiencing mental health conditions during the perinatal period, with one in seven reporting moderate to severe depression, and one in ten reporting moderate to severe anxiety (<xref ref-type="bibr" rid="B59">59</xref>). A recent survey in Ireland indicated that certain indices of sociodemographic and socioeconomic disadvantages such as being a young, single or first-time mother, lower education background, unemployment, or having relationship difficulties, increased the likelihood of poor mental health during the perinatal period (<xref ref-type="bibr" rid="B59">59</xref>).</p>
<p>In response to these challenges, the Department of Health in Ireland published the first <italic>National Maternity Strategy 2016&#x2013;2026</italic> to advocate for a holistic, women-centred, and biopsychosocial model of care, aiming to reduce the medicalisation of pregnancy and childbirth by promoting preventive measures and early intervention, particularly in relation to mental health (<xref ref-type="bibr" rid="B60">60</xref>, <xref ref-type="bibr" rid="B61">61</xref>). Complementing mental health policies, <italic>Sharing the Vision: A Mental Health Policy for Everyone</italic> (<xref ref-type="bibr" rid="B61">61</xref>) emphasises the need for a comprehensive, multidisciplinary approach that considers biological, psychological, and social factors contributing to mental illness.</p>
<p>Building on these strategic frameworks, Ireland launched <italic>the Specialist Perinatal Mental Health: Model of Care</italic> in 2017 (Health Service Executive, 2017) (<xref ref-type="bibr" rid="B62">62</xref>). This initiative led to the establishment of Specialist Perinatal Mental Health Services (SPMHS) across six major hospital groups, including the National Maternity Hospital, Rotunda Hospital, Coombe Women &amp; Infants University Maternity Hospital, University Maternity Hospital Limerick, Cork University Maternity Hospital, and Galway University Hospital. These services support women experiencing new onset, relapse, or recurrence of mental health disorders during the perinatal period. Each SPMHS team is led by a consultant psychiatrist in perinatal psychiatry and includes a multidisciplinary team comprising a non-consultant hospital doctor, advanced midwife practitioner, mental health nurse, senior clinical psychologist, mental health social worker, and occupational therapist. The primary focus is on the early support, assessment, and treatment of perinatal mental health disorders. Referrals to the service are accepted from healthcare professionals such as general practitioners, obstetricians, public health nurses, and midwives for various mental health difficulties, primarily perinatal mood and anxiety disorders (PMADs), including pregnancy-related anxiety and tokophobia.</p>
<p>Despite these advancements in awareness and service provision (<xref ref-type="bibr" rid="B5">5</xref>), recent studies (<xref ref-type="bibr" rid="B59">59</xref>, <xref ref-type="bibr" rid="B63">63</xref>, <xref ref-type="bibr" rid="B64">64</xref>) indicate that perinatal mental health services in Ireland remain insufficient. The surge in referrals to SPMHS has led to prioritisation of women with more severe symptoms, potentially delaying care for those with milder presentations (<xref ref-type="bibr" rid="B65">65</xref>). Additionally, stigma and shame surrounding mental health diagnoses often deter women from seeking help (<xref ref-type="bibr" rid="B66">66</xref>). Many avoid or discontinue psychotropic medication during pregnancy or breastfeeding due to concerns about potential risks, expressing a preference for non-pharmacological interventions (<xref ref-type="bibr" rid="B66">66</xref>). These findings underscore the pressing need for holistic, accessible, and effective treatment options for women requiring additional mental health support during the perinatal period.</p>
</sec>
<sec id="s2_3_2">
<label>2.3.2</label>
<title>Stakeholder perspectives and preferences</title>
<p>The MRC framework highlights that stakeholder involvement is critical to ensuring an intervention is contextually relevant and adaptable, responsive to the needs, values, and contexts of those they are intended to serve. To achieve this, a mixed-methods cross-sectional study named <italic>Music and Perinatal Wellbeing</italic> was carried out to explore stakeholders&#x2019; experiences and perspectives on music and music therapy in perinatal care. In the context of SAMT, key stakeholders are maternity service users, including both parents, and providers such as perinatal healthcare professionals and other perinatal care providers in Ireland. The <italic>Music and Perinatal Wellbeing</italic> study consisted of online surveys with 254 women and 11 partners, and 46 healthcare practitioners and follow-up interviews with six stakeholders recruited from the survey respondents (<xref ref-type="bibr" rid="B67">67</xref>&#x2013;<xref ref-type="bibr" rid="B69">69</xref>).</p>
<p>Findings revealed widespread recognition of music&#x2019;s benefits during pregnancy and childbirth, including support for relaxation, mood regulation, sleep, energy, bonding, labour, and the clinical environment. However, many respondents noted a lack of guidance on how to use music effectively during the perinatal period and expressed strong interest in the integration of music therapy into standard maternity care. Preferred programme features included support for relaxation, parent-infant bonding, and childbirth preparation (<xref ref-type="bibr" rid="B67">67</xref>, <xref ref-type="bibr" rid="B68">68</xref>).</p>
<p>Semi-structured interviews with two new mothers and four perinatal healthcare professionals further identified practical considerations for implementation. Stakeholders emphasised the importance of safe, holistic, and accessible support for women experiencing psychological distress, particularly when this affects bonding or maternal self-care. The third trimester and hospital admission were highlighted as key windows for intervention. Additionally, stakeholders stressed the need for structured guidelines and public awareness to support sustainable integration of music therapy into maternity care (<xref ref-type="bibr" rid="B69">69</xref>).</p>
</sec>
<sec id="s2_3_3">
<label>2.3.3</label>
<title>Co-creating and refining the intervention with patients</title>
<p>Building on the insights gained from stakeholder engagement and contextual analysis, the next critical step in the development of SAMT was co-creating the intervention directly with the women it aimed to support. This ensured that the design was not only informed by broader policy and service structures but also deeply attuned to individual experiences and preferences.</p>
<p>Co-creation involves working directly with end-users to tailor interventions to specific contexts, ensuring that the content and delivery are meaningful, relevant, and adaptable. This approach has been increasingly applied in health intervention development and has been shown to enhance both effectiveness and sustainability (<xref ref-type="bibr" rid="B70">70</xref>).</p>
<p>In the development of SAMT, co-creation was embedded in the therapeutic process. Pregnant participants were actively involved in shaping the intervention through co-designing the session structure, and the selection and creation of personalised music resources, including playlists and original songs that reflected their emotional and relational experiences. Session structures were flexibly adapted to accommodate individual preferences, evolving needs, and feedback over time. This dynamic and responsive approach allowed participants to engage meaningfully in the intervention and to influence its direction.</p>
<p>Importantly, co-creation fostered a sense of ownership among participants, which emerges through an empowerment process that supports openness, shared decision-making, and perceived control (<xref ref-type="bibr" rid="B70">70</xref>). By involving participants in the design and delivery of SAMT, the intervention was not only grounded in evidence and clinical expertise but also enriched by the voices and values of those it aimed to support.</p>
</sec>
</sec>
<sec id="s2_4">
<label>2.4</label>
<title>Drawing on existing theories and techniques to facilitate treatment outcomes</title>
<p>In line with the MRC guidance on complex intervention development, the development of SAMT was informed by existing theories that illuminate the psychological, social, and relational processes shaping maternal wellbeing and antenatal bonding. Four interrelated frameworks guided the therapeutic approach: salutogenesis and resource-oriented music therapy; humanistic person-centred theory; self-determination theory (SDT); and attachment theory, including concepts of communicative musicality and affect attunement.</p>
<sec id="s2_4_1">
<label>2.4.1</label>
<title>Salutogenesis theory, matrescence, and resource-oriented music therapy</title>
<p>The concept of salutogenesis, as introduced by Antonovsky in the late 1970s, focuses on individuals&#x2019; resources and capacity to create health rather than the focus on risks and disease (<xref ref-type="bibr" rid="B71">71</xref>). Complementing this, the concept of matrescence recognises the transition to motherhood as a normative developmental process involving significant physical, emotional, and social change rather than a condition or disease to be treated (<xref ref-type="bibr" rid="B72">72</xref>). This shift highlights the importance of resilience, adaptation, and the mobilisation of internal and external resources (<xref ref-type="bibr" rid="B73">73</xref>).</p>
<p>Within this framework, the resource-oriented music therapy approach is adopted as the theoretical foundation for SAMT. Resource-oriented music therapy is a therapeutic approach that focuses on identifying and utilising the inherent resources and strengths of individuals rather than solely addressing deficits or problems (<xref ref-type="bibr" rid="B74">74</xref>). Individual preferences, experiences and abilities are emphasised. The music therapist&#x2019;s role is to guide and support individuals in their musical journey and help them to recognise and utilise their musical resources. By focusing on strengths rather than limitation, resource-oriented music therapy promotes empowerment, self-awareness, and resilience. By leveraging music as a resource, music therapists can help pregnant women develop a sense of coherence and access generalised resistance resources to cope with the challenges from pregnancy onward. Mastnak (<xref ref-type="bibr" rid="B75">75</xref>) proposes that antenatal music therapy can achieve these through four focuses: 1. management of antenatal stress, anxiety, and depression through music; 2, mental and physical birth preparation through cognitive adjustment, emotional regulation, physical activity, relaxation, pain management, and social inclusion; 3. music-associated bonding and self-efficacy; and 4. acoustic stimulation to support foetal development.</p>
</sec>
<sec id="s2_4_2">
<label>2.4.2</label>
<title>Humanistic person-centred and self-determination theory</title>
<p>Another theoretical framework that underpins SAMT is humanistic person-centred music therapy that is built on Carl Roger&#x2019;s (<xref ref-type="bibr" rid="B76">76</xref>) humanistic person-centred theory and SDT (<xref ref-type="bibr" rid="B77">77</xref>). The humanistic person-centred approach is rooted in the belief that each individual possesses inherent worth and the capacity for growth and self-actualisation. Drawing on Carl Roger&#x2019;s person-centred therapy, the therapeutic relationship and environment are characterised by empathy (experiencing life from the client&#x2019;s perspective), unconditional positive regard (nonjudgemental and respectful acceptance), and congruence (transparency and trustworthiness). In humanistic music therapy (<xref ref-type="bibr" rid="B78">78</xref>), the psychotherapeutic space can facilitate &#x201c;personal and transpersonal development of the person through sound and music is facilitated, using an approach emphasising respect, acceptance, empathy and congruence&#x201d;. In the context of SAMT, these principles inform the therapeutic orientation of the music therapist who facilitates a supportive, safe and respectful space for musical and psychological exploration. Sessions are tailored to each woman&#x2019;s unique emotional experiences, cultural background, and personal preferences, allowing music to become a medium for self-expression, emotional processing, and connection. The &#x201c;music&#x201d; in SAMT is considered an embodiment of human agency and a resource in the form of social capital, through which individuals can work toward self-actualisation (<xref ref-type="bibr" rid="B79">79</xref>).</p>
<p>In addition, SAMT supports the basic psychological needs outlined in the SDT. SDT posits that wellbeing is fostered when three basic psychological needs are met: autonomy, competence, and relatedness (<xref ref-type="bibr" rid="B77">77</xref>). To support these needs, the person-centred, co-creative approach of SAMT allows individuals to choose which health needs they wish to address in each session and how they engage with music through an open, adaptable session structure. This freedom promotes autonomy by giving individuals control over their therapeutic experience, which is particularly important in mental health contexts and for those affected by trauma. In SAMT, competence may be reflected in women feeling empowered to express themselves, engage with their foetus through musical experiences, and experience a sense of accomplishment from singing, playing, or composing music for their baby. Relatedness is nurtured through shared musical experiences, attuned listening, and co-creation with both the music therapist and the foetus.</p>
</sec>
<sec id="s2_4_3">
<label>2.4.3</label>
<title>Attachment theory, communicative musicality and affect attunement</title>
<p>Attachment theory, first proposed by Bowlby (<xref ref-type="bibr" rid="B80">80</xref>), describes the dynamic and reciprocal relationship between the primary caregivers and their infant, with the aims to seek proximity and provide safe, security, protection, and affect regulation to the child (<xref ref-type="bibr" rid="B81">81</xref>, <xref ref-type="bibr" rid="B82">82</xref>). Secure attachment develops when caregivers respond promptly and consistently to an infant&#x2019;s distress signals, such as crying or seeking proximity, creating a reliable sense of safety that supports socio-emotional development throughout life (<xref ref-type="bibr" rid="B80">80</xref>, <xref ref-type="bibr" rid="B81">81</xref>). When these early bonds are disrupted due to factors such as maternal mental health difficulties, trauma, high-risk pregnancy, or social stressors, infants&#xa0;often develop insecure patterns such as avoidant (characterised by emotional withdrawal and suppression of attachment needs), ambivalent (marked by heightened anxiety and preoccupation with caregiver availability), or disorganised (involving contradictory, fear-based behaviours) attachment as adaptive responses to inconsistent, unavailable, or frightening caregiving (<xref ref-type="bibr" rid="B81">81</xref>, <xref ref-type="bibr" rid="B83">83</xref>).</p>
<p>Many scholars propose that the attachment bond begins during pregnancy, as the foetus is perceived as an individual with its own identity and distinct needs (<xref ref-type="bibr" rid="B84">84</xref>). The concept of &#x201c;mother-foetal attachment&#x201d; was first introduced by Cranley (<xref ref-type="bibr" rid="B85">85</xref>), who described it as &#x201c;the extent to which women engage in behaviours that represent an affiliation and interaction with their unborn child&#x201d; (p. 282). Muller (<xref ref-type="bibr" rid="B82">82</xref>)expanded on this by highlighting the role of preparedness, fantasies, affection, and interaction. Antenatal attachment is characterised by the parents&#x2019; emotional states, cognitive processes, and behavioural patterns directed towards the foetus, including activities such as naming the foetus, engaging in interaction, initiating communication, tenderly touching the abdomen, providing care, and undertaking preparations for the forthcoming arrival of the newborn. Strengthening this bond during pregnancy has been shown to positively influence postnatal attachment and reduce the risk of bonding disorders (<xref ref-type="bibr" rid="B84">84</xref>).</p>
<p>Communicative musicality, as described by Malloch and Trevarthen (<xref ref-type="bibr" rid="B86">86</xref>), refers to the innate musical qualities of human interaction that support emotional connection through rhythm, timing, and expressive contour. <italic>Affect attunement</italic>, introduced by Daniel Stern (<xref ref-type="bibr" rid="B87">87</xref>), describes how caregivers synchronise their emotional expressions and responses with those of infants, fostering emotional connection and attunement. These two concepts originally applied to the interaction between an infant and the caregiver after birth. Emerging evidence that foetuses respond to auditory stimuli from around 16 weeks&#x2019; gestation (<xref ref-type="bibr" rid="B88">88</xref>) suggests that these communicative processes may begin before birth, providing a foundation for early affective attunement through sound (<xref ref-type="bibr" rid="B89">89</xref>). In SAMT, singing and musical engagement are used to foster antenatal attachment by creating opportunities for emotional connection and rhythmic interaction. Maternal singing serves as a natural medium for soothing, bonding, and shared emotional expression (<xref ref-type="bibr" rid="B90">90</xref>). The soothing melodies and rhythmic patterns of music can help regulate the foetus emotional state and promote feelings of security and comfort, supporting positive emotional bonding even before birth (<xref ref-type="bibr" rid="B91">91</xref>). These theories and findings underscore the potential of SAMT during pregnancy on the formation and enrichment of the mother-foetal relationship, highlighting its important role in early intervention to prevent and repair disrupted attachment (<xref ref-type="bibr" rid="B92">92</xref>).</p>
</sec>
</sec>
<sec id="s2_5">
<label>2.5</label>
<title>Evaluating feasibility and efficacy through a proof-of-concept study</title>
<p>The MRC Framework for Developing and Evaluating Complex Interventions emphasises the importance of iterative testing to assess real-world applicability. In line with the guidance, the next phase of intervention development involved assessing the feasibility and preliminary efficacy of SAMT through a proof-of-concept (PoC) study. The full empirical findings of the SAMT PoC study have been published elsewhere (<xref ref-type="bibr" rid="B27">27</xref>) and a concise summary is provided here to support the methodological focus of this report.</p>
<p>This PoC study employed a convergent mixed methods design with pregnant women attending the SPMHS in Ireland. Quantitative data included pre- and post-intervention self-rated outcome (SRO) measures of mental wellbeing (SWEMWBS), anxiety (GAD-7), and antenatal attachment (PAI), collected at the beginning and after completion of the six SAMT sessions. Session-level ratings of anxiety and perceived closeness to the baby were recorded through Visual Analogue Scale (VAS) before and after each session. All SRO measures were self-administered by participants via online questionnaires accessed through links provided prior to each assessment point. Additionally, feasibility indicators including intervention adherence and fidelity were recorded. Further details on the feasibility indicators are reported in the Results section (3.11). Qualitative data were gathered through self-administered post-programme questionnaires and semi-structured interviews, which were conducted by an independent researcher not involved in the intervention to minimise bias.</p>
<p>Women with mental health conditions were referred to SAMT by the psychiatrist, midwife, nurse, and social worker at SPMHS. SAMT sessions were delivered by the lead researcher, who was a music therapist at SPMHS; therefore, therapist blinding was not feasible. A total of 12 women were enrolled, nine participants (mean age: 29 years; range: 23-36) completed SAMT and pre/post online questionnaires, and seven participated in semi-structured interviews. Findings indicated that SAMT was effective, feasible and well-received, with a 75% retention rate and high adherence (see 3.12 for further details). Statistically significant improvements with large effect sizes were observed in wellbeing (SWEMWBS: mean increased from 19.36 to 23.37; <italic>p</italic> &lt; 0.001; <italic>d</italic> = &#x2212;1.77), anxiety reduction (GAD-7: mean decreased from 10.33 to 4.11; <italic>p</italic> &lt; 0.001; <italic>d</italic> = 2.32), and antenatal attachment (PAI: median increased from 56 to 69; <italic>p</italic> = 0.007; <italic>r</italic> = &#x2212;0.89). Importantly, every individual participant showed positive improvement exceeding the minimal clinically important difference (MCID) across these outcomes regardless of delivery modes or component selection. Immediate reductions in anxiety and increased closeness to their baby were also observed after each session (VAS-anxiety: median decreased from 5 to 2; VAS-closeness: median increased from 7 to 8; both p &lt;.001; r = &#x2212;0.77), with effects increased progressively over the course of six sessions (<xref ref-type="bibr" rid="B27">27</xref>).</p>
<p>Qualitative feedback underscored the acceptability and therapeutic value of SAMT. Participants particularly valued the person-centred and co-creative approach, as some initially expressed apprehension about engaging in activities outside their comfort zone but felt reassured that the sessions were tailored to their individual needs and preferences. Many highlighted its positive impact on emotional regulation, bonding, and self-care. Although participants reported challenges such as technical issues, difficulty securing private space, and managing emotional responses during online sessions, they appreciated the flexibility of online delivery as crucial for sustaining engagement when faced with mobility limitations and long travel distances.</p>
<p>These findings support the potential of SAMT as a holistic, non-pharmacological intervention for perinatal mental health care, and lay the groundwork for future larger-scale effectiveness and health economic evaluations.</p>
</sec>
</sec>
<sec id="s3" sec-type="results">
<label>3</label>
<title>Results</title>
<p>This section provides a detailed description of SAMT following the TIDieR checklist (<xref ref-type="bibr" rid="B29">29</xref>):</p>
<p>Intervention Description (TIDieR Checklist Summary)</p>
<sec id="s3_1">
<label>3.1</label>
<title>Item #1: brief name</title>
<p>Specialised Antenatal Music Therapy (SAMT).</p>
</sec>
<sec id="s3_2">
<label>3.2</label>
<title>Item #2: Why</title>
<p>SAMT was developed to support emotional wellbeing, maternal&#x2013;foetal bonding, and anxiety and stress management during pregnancy. While originally designed for women attending specialist perinatal mental health services, the principles of SAMT are applicable to pregnant women more broadly. The intervention offers a non-pharmacological, non-invasive therapeutic option that promotes relaxation, emotional resilience, and a positive connection with the unborn baby.</p>
</sec>
<sec id="s3_3">
<label>3.3</label>
<title>Item #3: What (materials)</title>
<p>In-Person Sessions</p>
<list list-type="bullet">
<list-item>
<p>Private, dedicated therapy room</p></list-item>
<list-item>
<p>Range of musical instruments for expressive and bonding activities</p></list-item>
<list-item>
<p>Audio playback and recording equipment</p></list-item>
<list-item>
<p>Songbooks and lyric sheets</p></list-item>
<list-item>
<p>Guided relaxation scripts and live or recorded relaxation music</p></list-item>
<list-item>
<p>Access to music-streaming services</p></list-item>
</list>
<p>Online Sessions (In addition to the above)</p>
<list list-type="bullet">
<list-item>
<p>Secure video conferencing platform (e.g., Attend Anywhere)</p></list-item>
<list-item>
<p>Laptop or desktop computer with web camera</p></list-item>
<list-item>
<p>Headset with built-in microphone</p></list-item>
<list-item>
<p>Reliable internet connection</p></list-item>
</list>
<p>Materials for Participants</p>
<list list-type="bullet">
<list-item>
<p>Information leaflet with suggestions for home-based relaxation and bonding activities</p></list-item>
<list-item>
<p>Curated relaxation resources or playlists, provided as needed</p></list-item>
<list-item>
<p>Lyric sheets for personalised or collaboratively created songs</p></list-item>
</list>
</sec>
<sec id="s3_4">
<label>3.4</label>
<title>Item #4: What (procedures)</title>
<p>SAMT consisted of six weekly individual sessions, each lasting 45&#x2013;60 minutes. Sessions followed a flexible, person-centred, and co-creative structure that allowed the music therapist to tailor the therapeutic approach to the participant&#x2019;s emotional state, preferences, and clinical goals at the time of each appointment. The overall flow of each session remained consistent: grounding through breathwork at the start, collaborative selection of session content, and a closing relaxation or bonding exercise. Within this structure, participants exercised full autonomy in choosing among several open or selective components, while core elements&#x2014;music-assisted relaxation, bonding song identification, and antenatal musical bonding&#x2014;were incorporated with fidelity across all sessions.</p>
<p>Session 1 focused on orientation to SAMT, exploration of musical history and preferences, clarification of therapeutic goals, and an introduction to relaxation and bonding practices. Sessions 2&#x2013;5 deepened engagement with core and selective components, with increasing participant autonomy and ongoing negotiation of session pacing and content. From Session 4 onwards, the therapist introduced elements of therapeutic closure, encouraging participants to reflect on progress and consider the goals or creative tasks they wished to complete before the end of the programme. Session 6 served as a consolidation and closure session in which women reviewed their experiences, reflected on personal changes, and identified music-based strategies they intended to continue using in daily life.</p>
<p>The procedures were consistent across in-person, online, and hybrid delivery formats, with the only substantive difference being the availability of musical instruments in the in-person setting. <xref ref-type="table" rid="T2"><bold>Table&#xa0;2</bold></xref> summarises all core and selective components of SAMT, including their therapeutic goals and operational descriptions.</p>
<table-wrap id="T2" position="float">
<label>Table&#xa0;2</label>
<caption>
<p>SAMT therapeutic components, goals, and operational descriptions.</p>
</caption>
<table frame="hsides">
<thead>
<tr>
<th valign="middle" align="left">Component type</th>
<th valign="middle" align="left">Component</th>
<th valign="middle" align="left">Goal</th>
<th valign="middle" align="left">Description</th>
</tr>
</thead>
<tbody>
<tr>
<td valign="middle" align="left">Core</td>
<td valign="middle" align="left">Music-assisted relaxation</td>
<td valign="middle" align="left">Reduce anxiety and stress; support emotional regulation; promote self-compassion</td>
<td valign="middle" align="left">Guided relaxation supported by live musical improvisation or therapist-selected recorded music. Themes may include peaceful-place imagery (Session 1), passive relaxation (Sessions 1&#x2013;6), progressive muscle relaxation (Sessions 2&#x2013;6), visualisation-based relaxation (Sessions 3&#x2013;6), birth affirmations (Sessions 4&#x2013;6), and compassion-focused or loving-kindness sequences (Sessions 4&#x2013;6).</td>
</tr>
<tr>
<td valign="middle" align="left">Core</td>
<td valign="middle" align="left">Identifying a bonding song</td>
<td valign="middle" align="left">Support early attachment; facilitate emotional connection</td>
<td valign="middle" align="left">Collaborative selection of a personally meaningful song (e.g., lullaby, culturally relevant song, or song of kin) used throughout the intervention as the anchor for bonding experiences.</td>
</tr>
<tr>
<td valign="middle" align="left">Core</td>
<td valign="middle" align="left">Antenatal musical bonding (receptive and active)</td>
<td valign="middle" align="left">Strengthen maternal&#x2013;foetal attunement; enhance positive emotion; foster sensory connection</td>
<td valign="middle" align="left">Receptive bonding involves listening to the bonding song or therapist improvisation while visualising closeness, offering loving thoughts, or attending to foetal movement. Active bonding involves singing the bonding song (original, adapted, or vowel-based versions) and/or interactive songs incorporating gentle actions such as stroking, tapping, or rocking to engage with the baby through movement and voice.</td>
</tr>
<tr>
<td valign="middle" align="left">Selective</td>
<td valign="middle" align="left">Songwriting or personalising a song</td>
<td valign="middle" align="left">Support emotional expression; integrate pregnancy experiences; enhance agency</td>
<td valign="middle" align="left">Creation of an original song or adaptation of existing lyrics to reflect pregnancy-related thoughts, emotions, values, or hopes (e.g., modifying familiar melodies to express personal experiences).</td>
</tr>
<tr>
<td valign="middle" align="left">Selective</td>
<td valign="middle" align="left">Song discussion</td>
<td valign="middle" align="left">Facilitate emotional exploration; process life events</td>
<td valign="middle" align="left">Exploration of emotions, memories, and relational experiences evoked by chosen songs. Discussion may include themes such as grief, attachment, identity, loneliness, family dynamics, or the transition to motherhood.</td>
</tr>
<tr>
<td valign="middle" align="left">Selective</td>
<td valign="middle" align="left">Pregnancy or birth playlist creation</td>
<td valign="middle" align="left">Support relaxation; prepare for labour; enhance daily self-care</td>
<td valign="middle" align="left">Joint consideration of musical preferences and emotional responses to selected tracks. Identification of suitable music for childbirth preparation or daily wellbeing (e.g., relaxation, sleep support, emotional regulation).</td>
</tr>
<tr>
<td valign="middle" align="left">Selective</td>
<td valign="middle" align="left">Creative singing or music-making</td>
<td valign="middle" align="left">Encourage creativity and emotional release; deepen therapeutic rapport</td>
<td valign="middle" align="left">Vocal improvisation (e.g., toning, two-tone singing, free vocalisation) and/or instrument-based improvisation using percussion or melodic instruments (in-person sessions only).</td>
</tr>
</tbody>
</table>
</table-wrap>
</sec>
<sec id="s3_5">
<label>3.5</label>
<title>Item #5: Who provided</title>
<p>SAMT was delivered by an experienced, accredited music therapist with formal perinatal music therapy training and clinical experience in mental health.</p>
</sec>
<sec id="s3_6">
<label>3.6</label>
<title>Item #6: How</title>
<p>SAMT sessions were delivered individually. Partners or other family members could participate in selected sessions if clinically appropriate and aligned with therapeutic goals.</p>
</sec>
<sec id="s3_7">
<label>3.7</label>
<title>Item #7: Where</title>
<p>SAMT sessions were delivered either in-person or online based&#xa0;on participant preference. A hybrid option was also available, allowing participants to switch between formats if they&#xa0;were feeling unwell or faced travel difficulties. This flexible model supported continuity of care and responsiveness to individual needs.</p>
<sec id="s3_7_1">
<label>3.7.1</label>
<title>In-person setting</title>
<p>The in-person sessions were held in a quiet, accessible outpatient clinic located outside the maternity hospital environment to reduce medicalisation and potential triggering of trauma memories. The clinic provided transport access, parking, toilet and nappy changing facilities, and a private therapeutic space.</p>
</sec>
<sec id="s3_7_2">
<label>3.7.2</label>
<title>Online setting</title>
<p>Participants were encouraged to attend the online sessions at a private, quiet, and comfortable space where they could engage fully in therapeutic activities such as singing, music-making, deep relaxation, and discussion of sensitive matters. To support emotional safety and physical comfort, the following recommendations were provided:</p>
<list list-type="bullet">
<list-item>
<p>A supportive armchair with head and arm rests, if available.</p></list-item>
<list-item>
<p>A blanket, water, or a warm beverage for comfort.</p></list-item>
<list-item>
<p>Use of a laptop for optimal audio-visual quality (recommended but not mandatory).</p></list-item>
<list-item>
<p>A stable internet connection to ensure uninterrupted participation.</p></list-item>
</list>
</sec>
</sec>
<sec id="s3_8">
<label>3.8</label>
<title>Item #8: When and how much</title>
<p>SAMT consisted of six weekly sessions, with each lasting 45&#x2013;60 minutes.</p>
</sec>
<sec id="s3_9">
<label>3.9</label>
<title>Item #9: tailoring</title>
<p>Tailoring the individual experience was a core principle of SAMT, with a strong emphasis on fostering participant ownership. Each session was adapted to reflect the participant&#x2019;s emotional state, preferences, and therapeutic goals, ensuring they felt in control, empowered, and actively engaged.</p>
<p>Participants had full autonomy in selecting non-core components, and their agreement was always sought before engaging in core components such as music-assisted relaxation and bonding. Sessions began with open dialogue to identify current needs and preferred activities. For example, a participant who initially focused on bonding chose to explore a family conflict through song discussion and relaxation techniques.</p>
<p>Tailoring extended to the mode of delivery (in-person, online, or hybrid), choice of devices, and session environment. Some online participants found it uncomfortable to engage in creative activities with their camera or microphone on. To support privacy and comfort, they were given the freedom to mute themselves or turn off their camera, whatever helped maximise the therapeutic value of the session.</p>
</sec>
<sec id="s3_10">
<label>3.10</label>
<title>Item #10: modifications</title>
<p>No modifications or deviations were made to the original design of the SAMT. However, during the course of the proof-of-concept study, the COVID-19 pandemic escalated, leading to restrictions on in-person consultations. As a result, in-person engagement was temporarily suspended, and sessions were conducted exclusively online for a period.</p>
</sec>
<sec id="s3_11">
<label>3.11</label>
<title>Item #11: How well (planned)</title>
<p>In the proof-of-concept study, SAMT was delivered by the intervention developer hence no additional training was required in this phase. Intervention adherence and fidelity were monitored throughout the SAMT proof-of-concept study as part of the feasibility evaluation. Attendance, delivery mode, and component selection were tracked by the therapist after each session. Participants&#x2019; engagement outside of sessions was assessed using a Likert-scale item in the post-intervention questionnaire, capturing their use of music-based strategies and reflections between sessions.</p>
</sec>
<sec id="s3_12">
<label>3.12</label>
<title>Item #12: How well (actual)</title>
<p>Intervention adherence and fidelity were assessed with nine pregnant participants in the SAMT proof-of-concept study. On average, participants attended 5.33 out of 6 sessions (SD = 1), with missed sessions attributed to hospitalisation, family illness, early delivery, or proximity to due date.</p>
<p>All core components of SAMT (music-assisted relaxation, musical bonding, and bonding song identification) were delivered with 100% fidelity across both online and hybrid formats. Notably, all non-core components were selected by this cohort, with engagement rates ranging from 44% to 89%, reflecting the suitability of all components. Most participants (78%) attended sessions online, while 11% attended in-person only, and 11% transitioned from in-person to online. Post-intervention questionnaire responses indicated frequent use of relaxation resources (mean = 3.67/5) and singing to the baby (mean = 4/5) outside of sessions.</p>
<p>To consolidate and visually integrate the components described in this section, <xref ref-type="fig" rid="f1"><bold>Figure&#xa0;1</bold></xref> presents a logic model of SAMT. The model illustrates how the intervention&#x2019;s foundational inputs (evidence base, theoretical frameworks, stakeholder priorities, service context, and multidisciplinary expertise) inform its core design principles, including the person-centred, co-creative structure and flexible hybrid delivery. It also maps the core and optional therapeutic components, participant resources, and the intended short- and medium-term outcomes. This logic model provides a clear overview of the intervention to support transparency, replication, and future implementation within diverse perinatal mental health settings.</p>
<fig id="f1" position="float">
<label>Figure&#xa0;1</label>
<caption>
<p>Logic model for the specialised antenatal music therapy (SAMT) intervention.</p>
</caption>
<graphic mimetype="image" mime-subtype="tiff" xlink:href="fpsyt-17-1758640-g001.tif">
<alt-text content-type="machine-generated">Diagram illustrating Specialised Antenatal Music Therapy (SAMT). Key components include evidence, theories, stakeholders, context, and team. It features core and selective components like music-assisted relaxation and song discussion. Participant resources are bonding songs and relaxation recordings, aiming for therapeutic outcomes like reduced anxiety and improved wellbeing. Sessions are 45 to 60 minutes, delivered both in-person and online.</alt-text>
</graphic></fig>
</sec>
</sec>
<sec id="s4" sec-type="discussion">
<label>4</label>
<title>Discussion</title>
<p>This paper presents the development of the SAMT intervention, the first antenatal music therapy programme explicitly designed for women experiencing perinatal mental health difficulties and developed systematically using the MRC framework for complex interventions (<xref ref-type="bibr" rid="B31">31</xref>). By integrating the TIDieR checklist (<xref ref-type="bibr" rid="B29">29</xref>), the intervention is reported with sufficient clarity to support replication, fidelity assessment, and future adaptation. This contribution addresses a persistent gap in the literature, where most music therapy interventions lack detailed theoretical, procedural, and contextual description (<xref ref-type="bibr" rid="B93">93</xref>).</p>
<p>The development process combines empirical evidence, clinical expertise, and stakeholder engagement. This approach embodies key components of evidence-based practice models, which emphasise asking clinically relevant questions, acquiring and appraising evidence, applying findings to practice, and evaluating outcomes in collaboration with patients (<xref ref-type="bibr" rid="B94">94</xref>). A stakeholder-informed approach aligns with NICE guidelines that emphasise involving women, partners, and families in planning and decision-making throughout perinatal care, to improve acceptability, accessibility, and equity of interventions (<xref ref-type="bibr" rid="B95">95</xref>).</p>
<p>The developmental process also included feasibility and efficacy testing through a proof-of-concept study, which provided preliminary data that SAMT was acceptable, feasible, and therapeutically valuable. The successful referrals from the SPMHS team underscore the potential for other healthcare professionals such as GPs, obstetricians, midwives, and nurses to actively refer, support, and integrate SAMT within continuity-of-care frameworks. The findings are consistent with research demonstrating the benefits of music engagement for emotional regulation, bonding, and stress reduction during pregnancy (<xref ref-type="bibr" rid="B26">26</xref>, <xref ref-type="bibr" rid="B39">39</xref>, <xref ref-type="bibr" rid="B48">48</xref>, <xref ref-type="bibr" rid="B96">96</xref>). These findings provide a robust foundation for the next stages of intervention refinement and evaluation. Priorities include a multisite feasibility trial, the development of a therapist training and supervision framework, assessment of intervention acceptability across diverse populations, and economic evaluation.</p>
<p>Interpreting the findings from the proof-of-concept study requires careful consideration of music therapy as a complex intervention rather than a standardised therapeutic &#x201c;dose&#x201d; of music. Complexity refers to the interdependence of multiple components, the importance of therapeutic relationships, the adaptive nature of delivery, and the influence of contextual factors on participant outcomes. DeNora and Ansdell (<xref ref-type="bibr" rid="B97">97</xref>) highlight that music&#x2019;s influence is relational and situational, making variability in response an expected and clinically meaningful feature rather than a methodological problem. Instead, these varied responses offer valuable opportunities for therapists to engage in deeper therapeutic exploration through the therapeutic alliance that supports effective music therapy (<xref ref-type="bibr" rid="B98">98</xref>). From a therapeutic standpoint, these divergent responses are not barriers to fidelity but opportunities for exploration and meaning making within the therapeutic relationship. This perspective is consistent with established work on treatment manual development, which emphasises that complex relational interventions cannot function as rigid, standardised packages but must remain adaptable to individual clients, therapists, and contexts (<xref ref-type="bibr" rid="B99">99</xref>).</p>
<p>Recognising music therapy as a complex intervention also has methodological implications. This perspective challenges the assumption that individual musical activities can be treated as discrete, universally transferable &#x201c;active ingredients.&#x201d; As opposed to focusing on fixed techniques or activities (such as singing, songwriting, or improvisation), the open structure allows SAMT to be tailored for differing cultural contexts, delivery modes, and clinical populations without compromising fidelity. This echoes broader debates on balancing fidelity with contextual flexibility in music therapy and community music therapy (<xref ref-type="bibr" rid="B100">100</xref>). This adaptability positions SAMT as a scalable, woman-centred intervention suitable for implementation across varied maternity and mental health service settings. In this sense, SAMT contributes not only a novel antenatal music therapy protocol but also a model of how to conceptualise, implement, and evaluate music therapy interventions in a systemic way, aligning with the MRC framework (<xref ref-type="bibr" rid="B31">31</xref>).</p>
</sec>
<sec id="s5" sec-type="conclusions">
<label>5</label>
<title>Conclusion</title>
<p>Perinatal mental health is a global health concern that warrants urgent action to better support women, their families and society. SAMT provides a novel, theory-driven, and systematically developed model of antenatal music therapy tailored specifically for women experiencing psychological distress during pregnancy. By following the MRC framework and reporting the intervention comprehensively using the TIDieR checklist, this paper offers a transparent and replicable account of SAMT&#x2019;s rationale, components, delivery, and theoretical foundations. SAMT contributes an important methodological advance for the field and establishes a clear foundation for future feasibility, effectiveness, and implementation research. As perinatal mental health services continue to expand, SAMT represents a promising, woman-centred therapeutic approach with potential for integration into specialist care and for adaptation across diverse clinical settings.</p>
</sec>
</body>
<back>
<sec id="s6" sec-type="data-availability">
<title>Data availability statement</title>
<p>The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author.</p></sec>
<sec id="s7" sec-type="author-contributions">
<title>Author contributions</title>
<p>PC: Investigation, Writing &#x2013; review &amp; editing, Validation, Methodology, Software, Formal Analysis, Project administration, Funding acquisition, Resources, Data curation, Visualization, Writing &#x2013; original draft, Conceptualization. TM: Writing &#x2013; review &amp; editing, Supervision, Investigation, Conceptualization, Writing &#x2013; original draft, Validation, Project administration, Data curation, Resources, Methodology, Formal Analysis. SM: Resources, Supervision, Writing &#x2013; review &amp; editing, Conceptualization, Methodology, Validation, Investigation. MM: Conceptualization, Investigation, Resources, Validation, Funding acquisition, Writing &#x2013; review &amp; editing, Supervision, Project administration, Methodology.</p></sec>
<sec id="s9" sec-type="COI-statement">
<title>Conflict of interest</title>
<p>The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.</p></sec>
<sec id="s10" sec-type="ai-statement">
<title>Generative AI statement</title>
<p>The author(s) declared that generative AI was not used in the creation of this manuscript.</p>
<p>Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.</p></sec>
<sec id="s11" sec-type="disclaimer">
<title>Publisher&#x2019;s note</title>
<p>All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.</p></sec>
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