Creative Music Therapy in Newborns With Congenital Heart Disease (BOND)

University of Zurich (UZH)

Status: Enrolling

Conditions: Mother Child Interaction; Congenital Heart Disease

Treatments: Other: Creative Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05702203

BOND

Details and patient eligibility

About

In the context of a clinical trial, the investigators will evaluate if parent-infant interaction can be improved by a family integrated, individualised, interactive resource- and needs-oriented music therapy approach in the dyads of infants with congenital heart disease and their parents.

This intervention will be compared with the standard of care. Infants allocated to the control group will receive standard care during admission. Standard care includes involvement of a multi-professional team consisting of medical and nursing team, psychologists/psychiatrists, social workers, breastfeeding counsellor, speech therapist, nutritional counsellor and physiotherapists.

Full description

Open label single-centre randomised controlled interventional trial. All infants with congenital heart disease (CHD) and age <28 days admitted to the neonatal and paediatric intensive care unit at the University Children's Hospital in Zurich are eligible. Infants will be allocated 1:1 to creative music therapy (CMT) and standard care using block randomization with stratification by socio-economic score (SES, <8 vs >8) and risk of CHD according to the Risk Stratification for Congenital Heart Surgery (RACHS-2). CMT will be conducted 3x/week with a minimum of ten sessions. The primary outcome is mother-infant interaction at age 6 months assessed using a video of a feeding interaction at home, coded in a blinded manner with the Parent-Child Early Relational Assessment.

Enrollment: 164 estimated patients

Sex: All

Ages: 1 minute to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All newborn infants with CHD born >35 weeks of gestational and <28 days at diagnosis of CHD irrespective of severity of the heart disease
• Admitted to Neonatal Intensiv Care Unit/Pediatric Intensiv Care Unit (NICU/PICU) at the Children's University Hospital
• Infants with syndromes and /or confirmed chromosomal abnormalities

Exclusion criteria

• Gestational age at birth <35 weeks, age >28 days at diagnosis of CHD

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Infants allocated to the control group will receive standard care during admission. Standard care includes involvement of a multi-professional team consisting of medical and nursing team, psychologists/psychiatrists, social workers, breastfeeding counsellor, speech therapist, nutritional counsellor and physiotherapists

Creative Music Therapy

Experimental group

Description:

A certified, well-trained and experienced music therapist will formulate an individualized, culturally adapted treatment plan based on an initial infant-parent assessment, which includes assessment of parental needs, musical heritage, culture, context, and parental integration in the therapeutic process. During hospitalization 3 times per week 20 minutes of creative music therapy sessions will be performed, a minimum of 10 therapy session. After discharge, every other two weeks a music therapy session will be performed at home until the age of six months.

Treatment:

Other: Creative Music Therapy