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.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Colombia
Clínica Iberoamérica en Colombia
RECRUITING
Barranquilla
Clinica Pediátrica
RECRUITING
Bogotá
Clínica Universitaria Colombia
RECRUITING
Bogotá
Clínica Keralty Ibagué
RECRUITING
Ibagué
Poland
University of Gdańsk
RECRUITING
Gdansk
Contact Information
Primary
Mark Ettenberger, PhD
mark.ettenberger@gmx.at
+57 311 284 7635
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 102
Treatments
Experimental: Music therapy songwriting + standard care
The music therapy songwriting is a method frequently employed in music therapy sessions. This method involves the collaborative creation of lyrics and/or music with the participants. The intervention will consist of nine sessions, each of which will last approximately 30 to 45 minutes. Three sessions will be conducted per week until a minimum of six and a maximum of nine sessions are achieved.
No_intervention: Standard care
Standard care is the usual care provided to parents of newborns hospitalized in a neonatal intensive care unit (NICU). This care includes providing information about the baby's health status and recommendations during contact with the baby. Additionally, when a health professional identifies symptoms of mental health disturbance in the parents, they are referred to a mental health professional for appropriate management.
Related Therapeutic Areas
Sponsors
Leads: Claudia Aristizábal
Collaborators: Sanitas University

This content was sourced from clinicaltrials.gov

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