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

NCT06423092 | Recruiting DMC

• 1 other identifier: 166-23 UNV
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 5

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.

Conditions

Mental Health Impairment

Outcome Measures

Primary Outcomes (1)

• Postpartum depression

  Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS). This scale has values between 0 to 30 points. Higher scores mean a worse outcome.

  It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.

Secondary Outcomes (5)

• Anxiety

  It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.

• Well-being

  It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.

• Resilience

  It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.

• Stress

  It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.

• Coping

  It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.

Study Arms (2)

Music therapy songwriting + standard care

EXPERIMENTAL

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.

Other: Music therapy songwriting

Standard care

NO INTERVENTION

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.

Interventions

Music therapy songwriting OTHER

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.

Music therapy songwriting + standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claudia Aristizábal: lead
• Sanitas University: collaborator

Study Sites (5)

Clínica Iberoamérica en Colombia

Barranquilla, Atlántico, Colombia

RECRUITING

Clinica Pediátrica

Bogotá, Cundinamarca, Colombia

RECRUITING

Clínica Universitaria Colombia

Bogotá, Cundinamarca, Colombia

RECRUITING

Clínica Keralty Ibagué

Ibagué, Tolima Department, Colombia

RECRUITING

University of Gdańsk

Gdansk, Poland

RECRUITING

Central Study Contacts

Mark Ettenberger, PhD

CONTACT

+57 311 284 7635; mark.ettenberger@gmx.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: July 30, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (4); PL (1)