Creative Music Therapy in Newborns With Congenital Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorUniversity Children's Hospital, Zurich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Creative Music Therapy
Other interventionCreative 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.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Standard CareNo intervention 0 interventions
Group B: Creative Music TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1)
A video of a mother-infant interaction such as a feeding sequence is chosen as primary outcome. The video will be scored blinded according to the PCERA coding system. The variables/items in each scale are averaged together to form a total score between 1 and 5. Each variable/item is coded on a 5-point Likert-type scale from 1 (less positive and/or more negative affect or behaviour) to 5 (more positive and/or less negative affect or behaviour)
Time frame
at age 6 monthsSecondary outcomes
1
Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)
All items are rated with a score of 1 (low bonding) to 5 (high bonding), with higher scores indicating higher feelings of attachment toward the infant. The sum of the 19 items forms the total MPAS scale. The MPAS is composed of three scales: (1) quality of attachment, (2) absence of hostility, and (3) pleasure in interaction
Time frame
from baseline to six months of age2
Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)
Time frame
from baseline until six months age3
Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure
PBQ is a self-report screening measure of difficulties in the maternal-infant relationship and has been validated in the sample of mothers with different forms of maternal-infant disorders. The PBQ has 25 items rated on a 6-point scale (from 0 never to 5 always), with several reversely scored items, where a higher score indicates more disturbed bonding. Four subscales measure general factor (12 items), rejection and pathological anger (7 items), anxiety about infant (4 items), and incipient abuse (2 items)
Time frame
from baseline until six months age4
Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention)
Levels of oxytocin will be compraed before and after the CMT session in infants and parents
Time frame
from baseline until six months ageSponsors and contacts
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Source ClinicalTrials.gov