Music Therapy and High-risk Pregnancy

NCT06279559 | Recruiting

• 1 other identifier: MTinHRP_v1_10/01/2023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?
3. 3.How does the risk of preterm birth modulate the future attachment bond between mother and child?

Conditions

High Risk Pregnancy

Keywords

music-therapy; high-risk pregnancy; attachment bond

Outcome Measures

Primary Outcomes (6)

• Depressive symptoms

  Edimburg Prenatal Depression Scale (EPDS)

  administered before and within one week after the conclusion of the music therapy intervention

• State anxiety and trait anxiety

  State-Trait Anxiety Inventory - Forma Y (STAI-Y)

  administered before and within one week after the conclusion of the music therapy intervention

• Perceived stress

  Perceived Stress Scale (PSS)

  administered before and within one week after the conclusion of the music therapy intervention

• Perceived positive and negative feelings

  Positive and Negative affect Schedule (PANAS)

  administered before and within one week after the conclusion of the music therapy intervention

• Mother-fetus attachment bond

  Maternal Antenatal Attachment Scale (MAAS)

  administered before and within one week after the conclusion of the music therapy intervention

• Mother-child attachment bond

  Postpartum Attachment Scale (MPAS)

  administered three months after the childbirth

Study Arms (2)

clinical experimental group

EXPERIMENTAL

pregnant women with the risk of preterm birth who will undergo music therapy intervention

Behavioral: Music-therapy

clinical control group and non-clinical control group

NO INTERVENTION

pregnant women with the risk of preterm birth who will receive the usual ward care and pregnant women with pregnancy with a physiological course

Interventions

Music-therapy BEHAVIORAL

10 sessions of online music therapy held by expert music therapists

clinical experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years old
• Adequate knowledge of the Italian language
• Consent to participate
• Condition of risk of preterm birth

You may not qualify if:

• Positive history of mental retardation
• Difficulty understanding the Italian language
• Presence of diagnosis of psychiatric pathology
• Absence of informed consent
• Age over 18 years old
• Adequate knowledge of the Italian language
• Consent to participate
• Positive history of mental retardation
• Difficulty understanding the Italian language
• Presence of diagnosis of psychiatric pathology
• Absence of informed consent

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

Istituto Giannina Gaslini

Genova, 16147, Italy

RECRUITING

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Cristina Venturino

CONTACT

010 5636.2346; cristinaventurino@gaslini.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IT (1)