Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06423092

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

Led by Claudia Aristizábal · Updated on 2024-09-19

102

Participants Needed

5

Research Sites

95 weeks

Total Duration

On this page

Sponsors

C

Claudia Aristizábal

Lead Sponsor

S

Sanitas University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents or caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of 32 weeks or less
  • Newborn expected to stay in NICU for at least three weeks
  • Mother with an Edinburgh Postnatal Depression Scale (EPDS) score of 10 or higher and/or father with EPDS score of 7 or higher
  • Mother and/or father with a Generalized Anxiety Disorder Scale (GAD-7) score of 8 or higher
Not Eligible

You will not qualify if you...

  • Parents or caregivers with known hearing problems preventing participation in music therapy
  • Parents or caregivers with documented mental illness or cognitive impairment preventing completion of study or assessments
  • Parents or caregivers of premature infants in palliative or end-of-life care
  • Parents or caregivers of infants with known hearing impairment
  • Infants in custody of social services

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Clínica Iberoamérica en Colombia

Barranquilla, Atlántico, Colombia

Actively Recruiting

2

Clinica Pediátrica

Bogotá, Cundinamarca, Colombia

Actively Recruiting

3

Clínica Universitaria Colombia

Bogotá, Cundinamarca, Colombia

Actively Recruiting

4

Clínica Keralty Ibagué

Ibague, Tolima Department, Colombia

Actively Recruiting

5

University of Gdańsk

Gdansk, Poland

Actively Recruiting

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Research Team

M

Mark Ettenberger, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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