Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents

Last updated: September 6, 2024
Sponsor: Claudia Aristizábal
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Music therapy songwriting

Clinical Study ID

NCT06423092
166-23 UNV
  • Ages > 18
  • All Genders

Study Summary

The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.

The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The study population consisted of parents/caregivers of newborns hospitalized inneonatal intensive care units (NICUs) with gestational ages of ≤32 weeks andexpected hospitalizations of at least three weeks. In the case of a twin pregnancy,the firstborn infant was randomly assigned to one of the intervention groups, whileboth infants received the same treatment according to the outcome of randomization.

  • Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (EdinburghPostnatal Depression Scale)

  • Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety DisorderScale)

Exclusion

Exclusion Criteria:

  • Parents/caregivers with known auditory problems that prevent participation in MT.

Moreover parents/caregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.

  • Parents/caregivers of premature infants in palliative or end-of-life care, infantswith known hearing impairment, or infants in the custody of social services.

Study Design

Total Participants: 102
Treatment Group(s): 1
Primary Treatment: Music therapy songwriting
Phase:
Study Start date:
July 30, 2024
Estimated Completion Date:
June 30, 2026

Study Description

This study employs a multicenter, mixed-method approach, with a quantitative component that will be a pragmatic parallel controlled randomized clinical trial (RCT) and a qualitative component that will include phenomenological study. The quantitative component will assess depression and anxiety, which will be evaluated with the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Secondary outcomes will be resilience, coping, stress, and mental well-being. These outcomes will be measured in the first week of hospitalization (baseline measure) and then in weeks 1, 2, and 3 of the intervention. Changes in scores will be assessed to identify the effect, and mediating variables will be determined by multivariate analysis. Semi-structured interviews will be conducted on the parents' experience of music therapy songwriting for the baby.

The study will provide data on the effect of music therapy songwriting on the mental health of parents of neonates with brain injuries (PTNB) versus standard care and will document the lived experience of music therapy songs. The results may inform the standardization of this strategy in neonatal intensive care units (NICUs) to support and accompany parents and decrease the impact on their mental health.

Connect with a study center

  • Clínica Iberoamérica en Colombia

    Barranquilla, Atlántico
    Colombia

    Active - Recruiting

  • Clinica Pediátrica

    Bogotá, Cundinamarca
    Colombia

    Active - Recruiting

  • Clínica Universitaria Colombia

    Bogotá, Cundinamarca
    Colombia

    Active - Recruiting

  • Clínica Keralty Ibagué

    Ibagué, Tolima
    Colombia

    Active - Recruiting

  • University of Gdańsk

    Gdańsk,
    Poland

    Active - Recruiting

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