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Music Therapy With Cancer Affected Children and Their Families

Interaction-focused Music Therapy With Cancer Affected Children and Their Significant Others: a Randomized Controlled Feasibility Study With Subsequent Intervention (INMUT)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05534282
Acronym
INMUT
Enrollment
52
Registered
2022-09-09
Start date
2023-03-01
Completion date
2024-11-30
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer

Keywords

pediatrics oncology, music therapy, children, family, significant others

Brief 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.

Interventions

BEHAVIORALInteraction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)

Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists.

BEHAVIORALMusic Therapy with Children (MUT-K) (exp. group)

Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.

BEHAVIORALInteraction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)

Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.

Sponsors

Heidehof Foundation Stuttgart
CollaboratorUNKNOWN
Community Hospital Herdecke
CollaboratorUNKNOWN
Nordoff/Robbins Music Therapy Center Witten
CollaboratorUNKNOWN
Interprofessional Graduate Programm in Integrative Medicine IGIM
CollaboratorUNKNOWN
University of Witten/Herdecke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Parent-Child Interaction (APCI)Baseline, Change in 10th hour of interventionThe APCI captures child-reference interaction using mutual attunement, nonverbal communication, and emotional parental response. The diagnostic music therapy intervention sessions are conducted and evaluated by external, blinded, APCI-certified raters.

Secondary

MeasureTime frameDescription
Symptom Checklist-K-9 (SCL-9k)Baseline, Change in 10th hour of intervention, Change in 3 months after interventionThe Short Form Symptom Checklist (SCL-9k) captures impairment using 9 statements about somatization, obsessiveness, social insecurity, depressiveness, anxiety, aggressiveness, phobic anxiety, paranoia, and psychoticism.
Experience in Social Systems Questionnaire (EXIS)Baseline, Change in 10th hour of intervention, Change in 3 months after interventionEXIS, the Questionnaire on Experience in Private Social Systems, measures on basis of 12 items the degree of belonging, autonomy, accord, and confidence in the social system described as important within the past 2 weeks.
KINDL-Children/YouthVersion, Modul OncologyBaseline, Change in 10th hour of intervention, Change in 3 months after interventionThe KINDL uses 40 items to assess the psychological well-being, social relationships, physical functioning, and daily activities during the daily activities within the last week.
Wittener Ressources Questionnaire (WIRF)Baseline, Change in 10th hour of intervention, Change in 3 months after interventionWIRF captures resources on the basis of three domains of coping with general life experiences, difficult situations in the past, and current problems, using 12 items each. We will use the domain of coping with general life esperiences.
Goal Attainement Scale (GAS)Baseline, Change in 10th hour of intervention, Change in 3 months after interventionGAS captures in free text the subjective goals of children and their significant others. These are classified using the Bern Inventory for Therapy (BIT-T): (1) coping with specific problems and symptoms, (2) interpersonal goals, (3) well-being, (4) existential issues, (5) personal growth, (6) residual category.
Burden Assessment Scale (BAS)Baseline, Change in 10th hour of intervention, Change in 3 months after interventionThe BAS uses 19 items to survey personal stress, feelings of guilt, the need to interrupt and postpone important matters, and a changed and altered perspective of time in relation to the symptoms displayed by the ill relatives within the last 6 months.

Countries

Germany

Contacts

Primary ContactConstance Boyde, cand. Dr.
constance.boyde@uni-wh.de0049-2302/9267738
Backup ContactChristina Hunger-Schoppe, Prof. Dr.
christina.hunger-schoppe@uni-wh.de0049-2302/9267907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026