Music therapy for newborns with congenital heart disease
Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
This study is testing if music therapy can help improve the bonding between parents and their newborns with congenital heart disease compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 1 Minute to 28 Days |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT05702203 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a family-integrated, individualized music therapy approach to enhance parent-infant interactions in newborns diagnosed with congenital heart disease. Infants will be randomly assigned to receive either creative music therapy or standard care during their stay in the neonatal and pediatric intensive care unit. The intervention consists of three music therapy sessions per week for a minimum of ten sessions, with outcomes assessed at six months through video analysis of feeding interactions. The study aims to determine if music therapy can improve the quality of mother-infant bonding compared to standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants diagnosed with congenital heart disease who are less than 28 days old and admitted to the neonatal or pediatric intensive care unit.
Not a fit: Patients who are born before 35 weeks of gestation or diagnosed with congenital heart disease after 28 days will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the emotional and developmental outcomes for infants with congenital heart disease and their parents.
How similar studies have performed: While music therapy has been explored in various contexts, this specific approach for infants with congenital heart disease is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zurich
- University Children's Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Cornelia Hagmann, Prof. Dr.
- Email: cornelia.hagmann@kispi.uzh.ch
- Phone: 041 44 266 35 27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.