跳至主要内容
临床试验/NCT05534282
NCT05534282招募中不适用

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

University of Witten/Herdecke6 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
6
主要终点
Assessment of Parent-Child Interaction (APCI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Assessment of Parent-Child Interaction (APCI)

时间窗: 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.

次要结局

  • Wittener Ressources Questionnaire (WIRF)(Baseline, Change in 10th hour of intervention, Change in 3 months after intervention)
  • Symptom Checklist-K-9 (SCL-9k)(Baseline, Change in 10th hour of intervention, Change in 3 months after intervention)
  • Experience in Social Systems Questionnaire (EXIS)(Baseline, Change in 10th hour of intervention, Change in 3 months after intervention)
  • KINDL-Children/YouthVersion, Modul Oncology(Baseline, Change in 10th hour of intervention, Change in 3 months after intervention)
  • Burden Assessment Scale (BAS)(Baseline, Change in 10th hour of intervention, Change in 3 months after intervention)
  • Goal Attainement Scale (GAS)(Baseline, Change in 10th hour of intervention, Change in 3 months after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Constance Boyde

cand. Dr.

University of Witten/Herdecke

研究点 (6)

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