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Music Therapy and High-risk Pregnancy

NCT06279559 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-02-28

No results posted yet for this study

Summary

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.

Conditions

  • High Risk Pregnancy

Interventions

BEHAVIORAL

Music-therapy

10 sessions of online music therapy held by expert music therapists

Sponsors & Collaborators

  • Istituto Giannina Gaslini

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279559 on ClinicalTrials.gov