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

• ClinicalTrials.gov Identifier: NCT06423092
• Recruitment Status: Not yet recruiting
• First Posted: May 21, 2024
• Last Update Posted: May 21, 2024
• Sponsor: Claudia Aristizábal
• Collaborator: Sanitas University
• Information provided by (Responsible Party): Claudia Aristizábal, Sanitas University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mental Health Impairment	Other: Music therapy songwriting	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• 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.
• Estimated Study Start Date: June 2024
• Estimated Primary Completion Date: January 2026
• Estimated Study Completion Date: June 2026

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS).

Secondary Outcome Measures :

1. Anxiety [ Time Frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention. ]
   Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).
2. 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. ]
   The Warwick Edinburgh Mental Well-Being Scale (WEMWBS) will be employed to assess well-being.
3. Resilience [ Time Frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention. ]
   Resilience will be assessed with the Brief Resilience Scale (BRS).
4. Stress [ Time Frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention. ]
   Stress will be assessed with the 10-item Perceived Stress Scale (PSS-10).
5. Coping [ Time Frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention. ]
   Stress response will be assessed with the Brief COPE Inventory (Brief-COPE).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Mark Ettenberger, PhD; +57 311 284 7635; mark.ettenberger@gmx.at

Locations

Colombia

Clínica Iberoamérica en Colombia

Barranquilla, Atlántico, Colombia

Contact: Mark Ettenberger, PhD +57 605 3319424 mark.ettenberger@gmx.at

Clinica Pediátrica

Bogotá, Cundinamarca, Colombia

Contact: Mark Ettenberger, PhD (+57) 601 745 5100 mark.ettenberger@gmx.at

Clínica Universitaria Colombia

Bogotá, Cundinamarca, Colombia

Contact: Mark Ettenberger (+57) 6015948650 mark.ettenberger@gmx.at

Sub-Investigator: Marcela Beltrán, MSc

Principal Investigator: Mark Ettenberger, PhD

Sub-Investigator: Angélica Hernández, MSc

Sub-Investigator: Ana María Diaz, MSc

Sub-Investigator: Johana Benavides, MSc

Clínica Keralty Ibagué

Ibagué, Tolima, Colombia

Contact: Mark Ettenberger, PhD +57 60 1 646 6060 mark.ettenberger@gmx.at

Poland

University of Gdańsk

Gdańsk, Poland

Contact: Łucja Bieleninik, PhD +48 58 523 30 00 lucja.bieleninik@ug.edu.pl

Principal Investigator: Łucja Bieleninik, PhD

Sub-Investigator: Ilona Poćwierz-Marciniak, PhD

Sponsors and Collaborators

Claudia Aristizábal

Sanitas University

More Information

• Responsible Party: Claudia Aristizábal, Director, Sanitas University
• ClinicalTrials.gov Identifier: NCT06423092
• Other Study ID Numbers: 166-23 UNV
• First Posted: May 21, 2024
• Last Update Posted: May 21, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No