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

Mental Health Impairment Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423092
• Other study ID #: 166-23 UNV
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Sanitas University
• Contact: Mark Ettenberger, PhD
• Phone: +57 311 284 7635
• Email: mark.ettenberger[@]gmx.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: June 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Impairment

Intervention

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 if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support. The final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created.

Locations

Country	Name	City	State
Colombia	Clínica Iberoamérica en Colombia	Barranquilla	Atlántico
Colombia	Clinica Pediátrica	Bogotá	Cundinamarca
Colombia	Clínica Universitaria Colombia	Bogotá	Cundinamarca
Colombia	Clínica Keralty Ibagué	Ibagué	Tolima
Poland	University of Gdansk	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
Claudia Aristizábal	Sanitas University

Countries where clinical trial is conducted

Colombia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum depression	Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS).	It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.
Secondary	Anxiety	Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).	It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
Secondary	Well-being	The Warwick Edinburgh Mental Well-Being Scale (WEMWBS) will be employed to assess well-being.	It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
Secondary	Resilience	Resilience will be assessed with the Brief Resilience Scale (BRS).	It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Secondary	Stress	Stress will be assessed with the 10-item Perceived Stress Scale (PSS-10).	It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Secondary	Coping	Stress response will be assessed with the Brief COPE Inventory (Brief-COPE).	It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.