Music Therapy With Cancer Affected Children and Their Families (INMUT)

University of Witten/Herdecke

Status: Enrolling

Conditions: Pediatric Cancer

Treatments: Behavioral: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group); Behavioral: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group); Behavioral: Music Therapy with Children (MUT-K) (exp. group)

Study type: Interventional

Funder types: Other

Identifiers

NCT05534282

INMUT

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 3 patient groups

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

Behavioral: Music Therapy with Children (MUT-K) (exp. group)

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

Experimental group

Description:

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

Treatment:

Behavioral: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)