Montag, 29. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
INMUT

Music Therapy With Cancer Affected Children and Their Families

Rekrutierend

NCT-Nummer:
NCT05534282

Studienbeginn:
März 2023

Letztes Update:
06.03.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
University of Witten/Herdecke

Collaborator:
Heidehof Foundation Stuttgart, Community Hospital Herdecke, Nordoff/Robbins Music Therapy Center Witten, Interprofessional Graduate Programm in Integrative Medicine IGIM,

Studienleiter

Alfred Längler, Prof. Dr.
Principal Investigator
Gemeinschaftskrankenhaus Herdecke
Dominik Schneider, Prof. Dr.
Principal Investigator
Klinikum Dortmund
Michael Paulussen, Prof. Dr.
Principal Investigator
Vestische Kinderklinik Datteln

Kontakt

Christina Hunger-Schoppe, Prof. Dr.
Kontakt:
Phone: 0049-2302/9267907
E-Mail: christina.hunger-schoppe@uni-wh.de» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Gemeinschaftskrankenhaus Herdecke
58313 Herdecke
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Alfred Längler, Prof. Dr.
E-Mail: a.laengler@gemeinschaftskrankenhaus.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Assessment of Parent-Child Interaction (APCI) (Time Frame - Baseline, Change in 10th hour of intervention):
The 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 outcome:

1. KINDL-Children/YouthVersion, Modul Oncology (Time Frame - Baseline, Change in 10th hour of intervention, Change in 3 months after intervention):
The 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.

2. Symptom Checklist-K-9 (SCL-9k) (Time Frame - Baseline, Change in 10th hour of intervention, Change in 3 months after intervention):
The "Short Form Symptom Checklist" (SCL-9k) captures impairment using 9 statements about somatization, obsessiveness, social insecurity, depressiveness, anxiety, aggressiveness, phobic anxiety, paranoia, and psychoticism.

3. Experience in Social Systems Questionnaire (EXIS) (Time Frame - Baseline, Change in 10th hour of intervention, Change in 3 months after intervention):
EXIS, 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.

4. Burden Assessment Scale (BAS) (Time Frame - Baseline, Change in 10th hour of intervention, Change in 3 months after intervention):
The 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.

5. Wittener Ressources Questionnaire (WIRF) (Time Frame - Baseline, Change in 10th hour of intervention, Change in 3 months after intervention):
WIRF 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.

6. Goal Attainement Scale (GAS) (Time Frame - Baseline, Change in 10th hour of intervention, Change in 3 months after intervention):
GAS 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.

Studien-Arme

  • Experimental: Interaction-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
  • Experimental: Music 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.
  • Experimental: Interaction-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.

Geprüfte Regime

  • Interaction-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.
  • Music 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.
  • Interaction-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.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Music Therapy With Cancer Affected Children and Their Families"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.