跳至主要内容
临床试验/NCT06108375
NCT06108375招募中不适用

Differences in Acceptability of Music Therapy Sessions Played Live Compared to a Recording Thereof

University of Zurich2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年10月24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
25
试验地点
2
主要终点
intervention-specific acceptability questionnaire based on Theoretical Framework of Acceptability

研究概览

简要总结

The present study seeks to assess differences in feasibility and acceptability of music therapy played live and listening to a recording thereof at the palliative care ward of the University Hospital Zurich. As a secondary objective the investigators aim to extend the limited findings on the putative effect of music therapy in palliative care populations derived from objective measures of human autonomic response combined with subjective psychological outcomes to support evidence-based medicine. The investigators will implement a commercially available tracker, the wristband 287-2 by Corsano, to investigate multiple simultaneous biomarkers of autonomic response to music therapy and a recording thereof, such as heart rate, heart rate variability, electrodermal activity and distal body temperature.

To investigate subjective quality of life and psychological outcomes, the investigators will administer highly validated and widely used questionnaires, namely the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 15 Palliative Care, the Edmonton Symptom Assessment System and the Hospital Anxiety and Depression Scale.

详细描述

The power of music to raise the spirits and to heal the soul should not be underestimated. There is growing recognition of the significance of music as a complementary treatment in palliative care, which is reflected in the growing body of scientific literature on the subject and in the popularly of music therapy among palliative care patients themselves.

Palliative care describes the holistic approach in the treatment of patients with advanced or incurable diseases, such as terminal cancer. In addition to conventional medical and nursing care, critical psychological, social and spiritual support is provided in palliative care. To this end, an interdisciplinary team of doctors, nursing staff, physiotherapists, occupational therapists, social workers, psycho-oncologists, chaplains and music therapists is involved.

Music therapy is defined as "the systematic use of music within a therapeutic relationship which aims at restoring, maintaining and furthering emotional, physical and mental health". The aim of music therapy in palliative care, in contrast, is to relieve symptoms of distress and improve quality of life among patients in the advanced stages of oncological disease. In Germany, national oncological guidelines currently recommend music therapy as a treatment option to alleviate anxiety and existential fear.

Music therapy encompasses both active and receptive techniques. Active techniques involve the patient in the production of music, such that they sing or play a musical instrument, possibly making planned gifts of songs to loved ones or for memorial services, whereas receptive techniques guide the patient in listening to music, both prerecorded as well as performed for them live. In cancer patients, the focus is placed primarily on music-assisted relaxation, generation of imagery, songs and improvisation. This heterogeneity of techniques studied in the literature on music therapy precludes an understanding of precisely what aspects of music therapy are most beneficial. Despite a diversity of approach, findings are promising, which in itself may be an indication as to whether the whole of music therapy is perhaps greater than the sum of its parts.

To practice music therapy according to the standards of evidence-based medicine, it is necessary to specify the intervention performed as well as the musical instrument(s) used. Moderators such as individual patient preferences and experience with music also may play an appreciable role; however, these are rarely systematically investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old
  • Capacity to provide informed consent
  • Patients with established diagnosis of a metastatic cancer/severe illness with limited life expectancy on a palliative care ward at the University Hospital Zurich

排除标准

  • Inability to answer a questionnaire due to physical limitations as well as cognitive or linguistic reasons.

结局指标

主要结局

intervention-specific acceptability questionnaire based on Theoretical Framework of Acceptability

时间窗: immediately before and after the intervention

assesses intervention acceptability, values 8 - 40, higher = better outcome

次要结局

  • Qualitative open questions for patients(immediately before and after the intervention)
  • Heart rate(immediately before and after the intervention)
  • Hospital Anxiety and Depression Scale(immediately before and after the intervention)
  • Edmonton Symptom Assessment System(immediately before and after the intervention)
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 15 Palliative Care(immediately before and after the intervention)
  • Heart rate variability(immediately before and after the intervention)
  • Electrodermal activity (μS; skin conductance response)(immediately before and after the intervention)
  • Temperature(immediately before and after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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