Congenital Heart DiseaseBONDNCT05702203
Creative Music Therapy in Newborns With Congenital Heart Disease
A study testing Creative Music Therapy in people with Congenital Heart Disease and Mother Child Interaction, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Congenital Heart Disease, Mother Child Interaction
- What is being tested?
- Creative Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Nov 2022to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Gestational age at birth <35 weeks, age >28 days at diagnosis of CHD
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital Zurich
Zurich, 8032
Cornelia Hagmann, Prof. Dr. med., 041442663527, Cornelia.Hagmann@kispi.uzh.ch
Cornelia Hagmann, Prof. Dr. med.
About this study
Official title: 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.
Read the 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
- Being tested
- Creative Music Therapy
- Keywords
- Parental mental health, Magnetic resonance Imaging
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creative Music TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Creative Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at age 6 months
Secondary outcomes (18)
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
Measured: from baseline to six months of age
Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)
Measured: from baseline until six months age
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)
Measured: from baseline until six months age
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
Measured: from baseline until six months age
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.
Measured: from baseline until six months age
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
Measured: from baseline until six months age
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.
Measured: from baseline until six months age
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.
Measured: from baseline until six months age
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
Measured: from baseline until six months age
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
Measured: from baseline until six months age
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).
Measured: from baseline until six months age
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.
Measured: baseline and at six months age
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
Measured: baseline
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).
Measured: baseline an at six months age
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.
Measured: baseline
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.
Measured: baseline and before discharge from hospital
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.
Measured: at six months age
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
Measured: at six months age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start22 Nov 2022
- Primary completion21 Oct 2025 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702203
- Sponsor's protocol ID
- BOND
- Acronym
- BOND
- Status last verified
- Jan 2023
- First submitted
- 5 Oct 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05702203
- Acronym / sponsor ID
- BOND / BOND
- Conditions
- Congenital Heart Disease, Mother Child Interaction
- Keywords
- Parental mental health, Magnetic resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 21 Oct 2025 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Creative Music TherapyA 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. |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Gestational age at birth <35 weeks, age >28 days at diagnosis of CHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creative Music TherapyCreative 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. | Other | Creative Music Therapy |
Primary outcome
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)
18 secondary outcomes
Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)
Time frame: 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
Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure
Time frame: 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
Parental mental health as assessed by General health (GHQ-12)
Time frame: from baseline until six months age
Parental mental health as assessed by Patient Health Questionnaire
Time frame: 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
Parental mental health as assessed by Spielberger State Anxiety Scale (STAI)
Time frame: 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
Parental mental health as assessed by Parental stress scale (PSS:NICU)
Time frame: 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
Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU)
Time frame: baseline and at six months age
Socioeconomic status (SES)
Time frame: baseline
Paternal-infant interaction and protective factors as assessed by Resilience Scale 13
Time frame: baseline an at six months age
Paternal-infant interaction and protective factors as assessed by Big five inventory-10
Time frame: baseline
Infant secondary outcome as assessed by Brain magnetic resonance imaging
Time frame: 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
Infant secondary outcome as assessed by Questionnaire about screaming, feeding and sleeping (SFS)
Time frame: at six months age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creative Music Therapy in people with Congenital Heart Disease and Mother Child Interaction, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cornelia Hagmann, Prof. Dr. (041 44 266 35 27, cornelia.hagmann@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1) (time frame: at age 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.