Creative Music Therapy in Newborns With Congenital Heart Disease (BOND)

January 17, 2023 updated by: University Children's Hospital, Zurich

Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Recruiting
        • University Children's Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Cornelia Hagmann, Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1)
Time Frame: at age 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)
Time Frame: from baseline to six months of age
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
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
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
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)
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
Levels of oxytocin will be compraed before and after the CMT session in infants and parents
from baseline until six months age
Parental mental health as assessed by General health (GHQ-12)
Time Frame: from baseline until six months age
The 12-Item General Health Questionnaire (GHQ-12) consists of 12 items, assessing the severity of a psychological distress over the past few weeks using a 4-point Likert-type scale.
from baseline until six months age
Parental mental health as assessed by Patient Health Questionnaire
Time Frame: from baseline until six months age
The Patient Health Questionnaire is a self-administered version of the PRIME-MD diagnostic instrument to screen for depression. Respondents must recall how often certain symptoms have been experienced over the last two weeks
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
The EPDS is the most common 10-item scale questionnaire used to measure mother's postpartum depression symptoms; parents are asked to respond to ten items on a four-point Likert scale.
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
The STAI is widely used a 40-item self-report scale that assesses separate dimensions of "state" and "trait" anxiety. The state measurement assesses how the individual feels "right now" or at this moment. The trait anxiety measure addresses how the individuals feel generally. The rating is done on a four-point Likert scale.
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
The 10-item Perceived Stress Scale is widely used to measure self-reported stress. The questions are answered on a 5-point scale from 'never' to 'very often' and a total PSS score can be calculated by summing across all items
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
The German version of the scale consists of 13 items and assesses the extent of stress caused by experiences in the ICU. It comprises two subscales: infant behavior and appearance, and parental role alterations. Responses are given on a 6-point scale from 1 to 5
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
The PDS is a very commonly used 17-item self-report instrument that rates symptoms of PTSD according to their frequency on a 4-point scale from 0 (not at all) to 3 (almost always).
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
This widely used German self-report 22-item questionnaire will be used to assess social support. The answers a based on a 5-point Likert scale.
baseline and at six months age
Socioeconomic status (SES)
Time Frame: baseline
The parents will complete a questionnaire that assesses their education, occupation, and salary. SES is calculated according to Largo et al. by means of a 6-point score of both maternal education and paternal occupation. The lowest possible SES score for either the mother or the father is 1, the highest 6. The overall SES score is a simple addition of the 2 individual scores resulting in a value between 2 and 12
baseline
Paternal-infant interaction and protective factors as assessed by Resilience Scale 13
Time Frame: baseline an at six months age
RS13 is a self-assessment procedure to assess coping ability in terms of personal competence and individual resilience. This scale includes central aspects of resilience, such as emotional stability, joie de vivre, energy, openness to new things, optimism, and the ability to change perspective. A 7-point Likert scale forms the response options from 1 (No, not true) to 7 (Yes, exactly true).
baseline an at six months age
Paternal-infant interaction and protective factors as assessed by Big five inventory-10
Time Frame: baseline
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
baseline
Infant secondary outcome as assessed by Brain magnetic resonance imaging
Time Frame: baseline and before discharge from hospital
Resting state functional MRI (functional connectivity), diffusion weighted and tensor imaging (structural connectomics), magnetic resonance spectroscopy (brain metabolism), arterial spin labeling (cerebral perfusion), multi-component T2 relaxometry (myelination) and susceptible weighted imaging will be acquired.
baseline and before discharge from hospital
Infant secondary outcome as assessed by The Infant Behavior Questionnaire Revised (IBQ-R), Infant Temperament
Time Frame: at six months age
This is a well-established caregiver report measure of temperament for infants aged 3 to 12 months. This instrument assesses 6 domains of infant temperament (activity level, soothability, fear, distress to limitations, smiling and laughter, and duration of orienting). It consists of 91 items and 14 scales. Parents are asked to report, on a 7-point scale, the frequency with which infants have showed specific behaviors in common situations during the past week or 2 weeks.
at six months age
Infant secondary outcome as assessed by Questionnaire about screaming, feeding and sleeping (SFS)
Time Frame: at six months age
The SFS gives an overview of the child behavior regulation and the associated difficulties within the frame of parental assessments. Duration of crying, length of sleep, distractibility, dysfunctional communication patterns in calming strategies, bedtime rituals, feeding procedures and interpretations and explanations for the parents' problem, their own burden will be evaluated
at six months age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Anticipated)

October 21, 2025

Study Completion (Anticipated)

October 24, 2026

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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