NCT05702203

Creative Music Therapy in Newborns With Congenital Heart Disease

Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 1 Minute – 28 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Congenital Heart Disease
• Mother Child Interaction

Interventions

Type	Name	Description
OTHER	Creative Music Therapy	Creative Music Therapy 3x20 minutes per week during admission, at least 10 session during admission, after discharge once every other week until 6 months of age.

Timeline

• Start date: 2022-11-22
• Primary completion: 2025-10-21
• Completion: 2026-10-24
• First posted: 2023-01-27
• Last updated: 2023-01-27

Locations

1 site across 1 country: Switzerland