Creative Music Therapy in Newborns With Congenital Heart Disease

NCT05702203 | Recruiting DMC

• 1 other identifier: BOND
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Mother Child Interaction

Keywords

Parental mental health; Magnetic resonance Imaging

Outcome Measures

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)

  at age 6 months

Secondary Outcomes (18)

• Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)

  from baseline to six months of age

• Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)

  from baseline until six months age

• Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure

  from baseline until six months age

• Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention)

  from baseline until six months age

• Parental mental health as assessed by General health (GHQ-12)

  from baseline until six months age

Study Arms (2)

Standard Care

NO INTERVENTION

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

Creative Music Therapy

EXPERIMENTAL

A certified, well-trained and experienced music therapist will formulate an individualized, culturally adapted treatment plan based on an initial infant-parent assessment, which includes assessment of parental needs, musical heritage, culture, context, and parental integration in the therapeutic process. During hospitalization 3 times per week 20 minutes of creative music therapy sessions will be performed, a minimum of 10 therapy session. After discharge, every other two weeks a music therapy session will be performed at home until the age of six months.

Other: Creative Music Therapy

Interventions

Creative Music Therapy OTHER

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.

Creative Music Therapy

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- Gestational age at birth \<35 weeks, age \>28 days at diagnosis of CHD

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Cornelia Hagmann, Prof. Dr.

CONTACT

041 44 266 35 27; cornelia.hagmann@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: January 27, 2023
• Study Start: November 22, 2022
• Primary Completion: October 21, 2025
• Study Completion (Estimated): October 24, 2026
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

CH (1)