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

Primary Purpose

Congenital Heart Disease, Mother Child Interaction

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Creative Music Therapy
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring Parental mental health, Magnetic resonance Imaging

Eligibility Criteria

1 Minute - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Children's Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Creative Music Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)
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)
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
Parental mental health as assessed by General health (GHQ-12)
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.
Parental mental health as assessed by Patient Health Questionnaire
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
Parental mental health as assessed by Edinburgh Postnatal Depression Scale (EPDS)
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.
Parental mental health as assessed by Spielberger State Anxiety Scale (STAI)
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.
Parental mental health as assessed by Perceived Stress SCale (PSS-10)
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
Parental mental health as assessed by Parental stress scale (PSS:NICU)
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
Parental mental health as assessed by Post traumatic diagnostic scale DSM-5 (PDS)
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).
Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU)
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.
Socioeconomic status (SES)
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
Paternal-infant interaction and protective factors as assessed by Resilience Scale 13
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).
Paternal-infant interaction and protective factors as assessed by Big five inventory-10
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
Infant secondary outcome as assessed by Brain magnetic resonance imaging
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.
Infant secondary outcome as assessed by The Infant Behavior Questionnaire Revised (IBQ-R), Infant Temperament
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.
Infant secondary outcome as assessed by Questionnaire about screaming, feeding and sleeping (SFS)
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

Full Information

First Posted
October 5, 2022
Last Updated
January 17, 2023
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05702203
Brief Title
Creative Music Therapy in Newborns With Congenital Heart Disease
Acronym
BOND
Official Title
Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
October 21, 2025 (Anticipated)
Study Completion Date
October 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Mother Child Interaction
Keywords
Parental mental health, Magnetic resonance Imaging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Arm Title
Creative Music Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Creative Music Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1)
Description
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 months
Secondary Outcome Measure Information:
Title
Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)
Description
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 age
Title
Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)
Time Frame
from baseline until six months age
Title
Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure
Description
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 age
Title
Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention)
Description
Levels of oxytocin will be compraed before and after the CMT session in infants and parents
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by General health (GHQ-12)
Description
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.
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by Patient Health Questionnaire
Description
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
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by Edinburgh Postnatal Depression Scale (EPDS)
Description
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.
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by Spielberger State Anxiety Scale (STAI)
Description
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.
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by Perceived Stress SCale (PSS-10)
Description
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
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by Parental stress scale (PSS:NICU)
Description
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
Time Frame
from baseline until six months age
Title
Parental mental health as assessed by Post traumatic diagnostic scale DSM-5 (PDS)
Description
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).
Time Frame
from baseline until six months age
Title
Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU)
Description
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.
Time Frame
baseline and at six months age
Title
Socioeconomic status (SES)
Description
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
Time Frame
baseline
Title
Paternal-infant interaction and protective factors as assessed by Resilience Scale 13
Description
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).
Time Frame
baseline an at six months age
Title
Paternal-infant interaction and protective factors as assessed by Big five inventory-10
Description
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
Time Frame
baseline
Title
Infant secondary outcome as assessed by Brain magnetic resonance imaging
Description
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.
Time Frame
baseline and before discharge from hospital
Title
Infant secondary outcome as assessed by The Infant Behavior Questionnaire Revised (IBQ-R), Infant Temperament
Description
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.
Time Frame
at six months age
Title
Infant secondary outcome as assessed by Questionnaire about screaming, feeding and sleeping (SFS)
Description
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
Time Frame
at six months age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelia Hagmann, Prof. Dr.
Phone
041 44 266 35 27
Email
cornelia.hagmann@kispi.uzh.ch
Facility Information:
Facility Name
University Children's Hospital Zurich
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelia Hagmann, Prof. Dr. med.
Phone
041442663527
Email
Cornelia.Hagmann@kispi.uzh.ch
First Name & Middle Initial & Last Name & Degree
Cornelia Hagmann, Prof. Dr. med.

12. IPD Sharing Statement

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Creative Music Therapy in Newborns With Congenital Heart Disease

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