Clinical trial NCT05702203: Creative Music Therapy in Newborns With Congenital Heart Disease
Official title: Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Mother Child Interaction
Keywords: Parental mental health
Magnetic resonance Imaging
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 164
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1)
timeFrame: at age 6 months
Secondary outcomes:
measure: Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)
timeFrame: from baseline to six months of age
measure: Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)
timeFrame: from baseline until six months age
measure: Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure
timeFrame: from baseline until six months age
measure: Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention)
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by General health (GHQ-12)
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by Patient Health Questionnaire
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by Spielberger State Anxiety Scale (STAI)
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by Perceived Stress SCale (PSS-10)
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by Parental stress scale (PSS:NICU)
timeFrame: from baseline until six months age
measure: Parental mental health as assessed by Post traumatic diagnostic scale DSM-5 (PDS)
timeFrame: from baseline until six months age
measure: Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU)
timeFrame: baseline and at six months age
measure: Socioeconomic status (SES)
timeFrame: baseline
measure: Paternal-infant interaction and protective factors as assessed by Resilience Scale 13
timeFrame: baseline an at six months age
measure: Paternal-infant interaction and protective factors as assessed by Big five inventory-10
timeFrame: baseline
measure: Infant secondary outcome as assessed by Brain magnetic resonance imaging
timeFrame: baseline and before discharge from hospital
measure: Infant secondary outcome as assessed by The Infant Behavior Questionnaire Revised (IBQ-R), Infant Temperament
timeFrame: at six months age
measure: Infant secondary outcome as assessed by Questionnaire about screaming, feeding and sleeping (SFS)
timeFrame: at six months age
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
References: