Creative Music Therapy in Newborns With Congenital Heart Disease

NCT ID: NCT05702203

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2026-10-24

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.

Conditions

Congenital Heart Disease; Mother Child Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Creative Music Therapy

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.

Group Type: EXPERIMENTAL

Creative Music Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Children's Hospital Zurich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Cornelia Hagmann, Prof. Dr.

Role: CONTACT

cornelia.hagmann@kispi.uzh.ch

041 44 266 35 27

Facility Contacts

Cornelia Hagmann, Prof. Dr. med.

Role: primary

Cornelia.Hagmann@kispi.uzh.ch

041442663527

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BOND

Identifier Type: -

Identifier Source: org_study_id