Clinical trial NCT06423092: Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Impairment
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: Sanitas University
First posted: 2024-05-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Postpartum depression
timeFrame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.
Secondary outcomes:
measure: Anxiety
timeFrame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
measure: Well-being
timeFrame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
measure: Resilience
timeFrame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
measure: Stress
timeFrame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
measure: Coping
timeFrame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Clínica Iberoamérica en Colombia
state: Atlántico
city: Bogotá
country: Colombia
facility: Clinica Pediátrica
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Clínica Universitaria Colombia
state: Cundinamarca
city: Ibagué
country: Colombia
facility: Clínica Keralty Ibagué
state: Tolima
city: Gdańsk
country: Poland
facility: University of Gdańsk
Study officials:
References: