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Trial Title:
Music Therapy With Cancer Affected Children and Their Families
NCT ID:
NCT05534282
Condition:
Pediatric Cancer
Conditions: Keywords:
pediatrics oncology
music therapy
children
family
significant others
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)
Description:
Interaction-focused music therapy with children with cancer and their significant others,
delivered by trained music therapists.
Arm group label:
Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)
Intervention type:
Behavioral
Intervention name:
Music Therapy with Children (MUT-K) (exp. group)
Description:
Interaction-focused music therapy with children with cancer without the involvement of
significant others, delivered by trained music therapists.
Arm group label:
Music Therapy with Children (MUT-K) (exp. group)
Intervention type:
Behavioral
Intervention name:
Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)
Description:
Study participants randomized to this group receive the intervention INMUT 10 weeks after
the experimental groups.
Arm group label:
Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)
Summary:
Background: Pediatric oncology patients and their families are in an existentially
threatening situation for which music therapy has proven as a cross-linguistic field of
action: the creative act of making music offers the possibility of strengthening
individual competences and makes socio-psycho-biological conflicts tangible in a very
direct way. Although music therapy is an established component of multimodal care and the
inclusion of significant others in the therapy setting is recommended, there has been
little clinical research on music therapy interaction processes in the family system. The
researchers have designed a randomized controlled pilot trial (INMUT) that specifically
addresses family interaction in a multi-person setting.
Methods: The examiners investigate the efficacy of music therapy interventions involving
the parent-child dyad (INMUT-KB, n=16) compared to music therapy interventions involving
only the child (MUT-K, n=16) and a waiting group without intervention (WG, n=10).
Research questions: 1) Does the parent-child interaction improves in mutual attunement,
nonverbal communication, and emotional parental response? 2) Are there effects on quality
of life, psychosocial and psychosomatic impairments, and system-related level of
functioning? Evaluation tools: Primary goals will be assessed by the music therapy-based
Assessment of parent-child interaction (APCI) pre and post. The secondary objectives will
be assessed by self-reports in form of the psychometric questionnaires KINDL, Experience
in Social Systems Questionnaire (EXIS), Burden Assessment Scale (BAS) and Symptom
Checklist-K-9 (SCL-9K) pre, post and follow up.
Discussion: The investigators hope for an improvement of the primary and secondary
endpoints through participation in music therapy as a basis for a needs-oriented
accompaniment of families.
Criteria for eligibility:
Criteria:
Inclusion Criteria, Children:
- cancer diagnosis
- inpatient (e.g. GKH)
- no cognitive and auditory dysfunction
Exclusion Criteria, Children:
- Serious comorbidity with impairment of brain-organic functions
- BMI<14
- serious physical comorbidity that does not allow specific assessment of
psychosomatic constructs with certainty
- withdrawal of informed consent
Inclusion Criteria, Important Reference Persons:
- e.g. father, mother, siblings
Exclusion Criteria, Important Reference Persons:
- withdrawal of consent
Gender:
All
Gender based:
Yes
Minimum age:
5 Years
Maximum age:
13 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Vestische Kinderklinik Datteln
Address:
City:
Datteln
Zip:
45711
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Michael Paulussen, Prof. Dr.
Email:
Paulussen Michael
Facility:
Name:
Klinikum Dortmund
Address:
City:
Dortmund
Zip:
44137
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Dominik Schneider, Prof. Dr.
Email:
dominik.schneider@klinikumdo.de
Facility:
Name:
Gemeinschaftskrankenhaus Herdecke
Address:
City:
Herdecke
Zip:
58313
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alfred Längler, Prof. Dr.
Email:
a.laengler@gemeinschaftskrankenhaus.de
Investigator:
Last name:
Alfred Längler, Prof. Dr.
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
University of Witten/Herdecke
Agency class:
Other
Collaborator:
Agency:
Heidehof Foundation Stuttgart
Agency class:
Other
Collaborator:
Agency:
Community Hospital Herdecke
Agency class:
Other
Collaborator:
Agency:
Nordoff/Robbins Music Therapy Center Witten
Agency class:
Other
Collaborator:
Agency:
Interprofessional Graduate Programm in Integrative Medicine IGIM
Agency class:
Other
Source:
University of Witten/Herdecke
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05534282
