Music therapy songwriting for parents of preterm newborns in the NICU

Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.

This study is testing if music therapy songwriting can help parents of preterm newborns in the NICU feel less anxious and depressed compared to just receiving standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sanitas University (Academic / other)
• Locations: 5 sites (Barranquilla, Atlántico and 4 other locations)
• Trial ID: NCT06423092 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of music therapy songwriting on the mental health of parents with preterm newborns in the neonatal intensive care unit (NICU). It employs a multicenter, mixed-method approach, combining a randomized controlled trial to quantitatively assess depression and anxiety levels with qualitative interviews to explore parents' lived experiences. The primary goal is to determine if music therapy, alongside standard care, can reduce postpartum depression risk compared to standard care alone. Outcomes will be measured at various intervals during the NICU stay to evaluate the effectiveness of the intervention.

Who should consider this trial

Good fit: Ideal candidates are parents or caregivers of preterm infants hospitalized in NICUs with gestational ages of 32 weeks or less, who exhibit signs of depression or anxiety.

Not a fit: Parents with known auditory problems or severe mental illness that prevents participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the mental health and well-being of parents with preterm newborns.

How similar studies have performed: Other studies have shown promising results with music therapy in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected 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, while both 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 (Edinburgh Postnatal Depression Scale)
* Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)

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, infants with known hearing impairment, or infants in the custody of social services.

Where this trial is running

Barranquilla, Atlántico and 4 other locations

• Clínica Iberoamérica en Colombia — Barranquilla, Atlántico, Colombia (Recruiting)
• Clinica Pediátrica — Bogotá, Cundinamarca, Colombia (Recruiting)
• Clínica Universitaria Colombia — Bogotá, Cundinamarca, Colombia (Recruiting)
• Clínica Keralty Ibagué — Ibague, Tolima Department, Colombia (Recruiting)
• University of Gdańsk — Gdansk, Poland (Recruiting)

Study contacts

• Study coordinator: Mark Ettenberger, PhD

Conditions Mental Health Impairment