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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClaudia Aristizábal

About this trial

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

Qualifiers

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)

Disqualifiers

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

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.

Trial design

Treatments tested in this trial

  • Music therapy songwriting

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Claudia Aristizábal

Lead sponsor

Sanitas University

Sponsor institution

Sanitas University

Collaborator