protocolSection identificationModule nctId: NCT06279559, orgStudyIdInfo id: MTinHRP_v1_10/01/2023, briefTitle: Music Therapy and High-risk Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Istituto Giannina Gaslini, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?3. How does the risk of preterm birth modulate the future attachment bond between mother and child?Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question., conditionsModule conditions: High Risk Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Music-therapy, outcomesModule primaryOutcomes measure: Depressive symptoms, primaryOutcomes measure: State anxiety and trait anxiety, primaryOutcomes measure: Perceived stress, primaryOutcomes measure: Perceived positive and negative feelings, primaryOutcomes measure: Mother-fetus attachment bond, primaryOutcomes measure: Mother-child attachment bond, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Giannina Gaslini, status: RECRUITING, city: Genova, zip: 16147, country: Italy, contacts name: Cristina Venturino, role: CONTACT, phone: 010 5636.2346, email: cristinaventurino@gaslini.org, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False