Creative Music Therapy in Newborns With Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Creative Music Therapy.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Mother Child Interaction. Basic parameters: 1 Minute — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1) [Time frame: at age 6 months]
Secondary outcome measures (12)
- Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS) [Time frame: from baseline to six months of age]
- Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ) [Time frame: from baseline until six months age]
- Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure [Time frame: from baseline until six months age]
- Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention) [Time frame: from baseline until six months age]
- Parental mental health as assessed by General health (GHQ-12) [Time frame: from baseline until six months age]
- Parental mental health as assessed by Patient Health Questionnaire [Time frame: from baseline until six months age]
- Parental mental health as assessed by Edinburgh Postnatal Depression Scale (EPDS) [Time frame: from baseline until six months age]
- Parental mental health as assessed by Spielberger State Anxiety Scale (STAI) [Time frame: from baseline until six months age]
- Parental mental health as assessed by Perceived Stress SCale (PSS-10) [Time frame: from baseline until six months age]
- Parental mental health as assessed by Parental stress scale (PSS:NICU) [Time frame: from baseline until six months age]
- Parental mental health as assessed by Post traumatic diagnostic scale DSM-5 (PDS) [Time frame: from baseline until six months age]
- Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU) [Time frame: baseline and at six months age]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Switzerland · 1 center
- University Children's Hospital Zurich — Zurich
Identifiers
NCT: NCT05702203 · BOND