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.

Overview

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.

Interventions

• Other Music therapy songwriting
  Session 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed. Sessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics

Primary outcome measures

• Postpartum depression [Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.]

Secondary outcome measures (5)

• Anxiety [Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.]
• Well-being [Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.]
• Resilience [Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.]
• Stress [Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.]
• Coping [Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Colombia · 4 centers

• Clínica Iberoamérica en Colombia — Barranquilla
• Clinica Pediátrica — Bogotá
• Clínica Universitaria Colombia — Bogotá
• Clínica Keralty Ibagué — Ibague

Poland · 1 center

• University of Gdańsk — Gdansk

Identifiers

NCT: NCT06423092 · 166-23 UNV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗