Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06108375 |
| Other study ID # |
MUSIC |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 24, 2023 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Zurich |
| Contact |
David Blum, Prof.Dr.med. |
| Phone |
+41 43 253 37 42 |
| Email |
david.blum[@]usz.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Music therapy is conventionally administered by a trained music therapist and individual
therapy sessions typically last 20 minutes. Training backgrounds of therapists vary, whereby
in the United States a bachelor's degree in music therapy is the minimum requirement and
board certification must follow in order for professional practice.
Few studies have investigated the efficacy of music therapy in palliative care patients. An
emerging body of scientific literature in this clinical population suggests that music
therapy may alleviate physical pain as well as psychological, social and emotional suffering.
Spiritual needs may particularly benefit from music therapy.
Furthermore, a meta-analysis could show significant positive effects of music therapy on
psychological wellbeing, physical symptoms and overall quality of life. Music therapy may
favour various routine overarching themes in palliative care as well, such as pain
management, relaxation, joy, hope, intensified spirituality and improved quality of life and
may reduce anxiety and depression. Music therapy may outperform verbal exercises in inducing
relaxation and reducing fatigue but not pain.
Despite the generally promising findings suggesting a benefit to psychological well-being
assessed by subjective methods (e.g., visual analog scales, questionnaires, etc.) there is
scant evidence derived from experiments utilizing objective outcome measures (e.g., autonomic
response, etc.) with rigorous study design to support the efficacy of music therapy.
Findings derived from autonomic data suggest a benefit of music therapy characterized by
increased parasympathetic tone accompanying improved subjective ratings of relaxation.
Boosted high-frequency heart rate (HR) oscillations coincided with subjective relaxation
score from visual analog scale after music therapy. In addition, blood volume pulse amplitude
(BVP-A) was increased from baseline to post-therapy, indicating heightened vascular dilation
due to greater parasympathetic activation, although just below the threshold of statistical
significance (p = 0.07). In another analysis in the same sample, during music therapy higher
levels of parasympathetically-mediated HR variability (HRV) were observed. Resting HR and
blood pressure (BP) were reduced, whereas relaxation, comfort and happiness were increased.
Increases in distal body temperature was observed in a sample of individuals undergoing
chemotherapy. Anxiety related to chemotherapy was reduced by music therapy in this sample.
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.
The proposed risk category of this study is A. Justification for this risk categorization is
reflected in the safe and relatively low burden of the study design, which requires the
participants to undergo music therapy, complete questionnaires and wear a small
wristwatch-like apparatus for a few minutes. Moreover, compared to conventional clinical
measurement of human autonomic response, which typically involves skin disinfection and
abrading followed by application of adhesive electrodes, the 287-2 wristband by Corsano is
comparatively far less invasive and therefore represents diminished burden for the patient
during their participation in the study. Music therapy and questionnaires (EORTC QLQ-C15-PAL,
ESAS and HADS) are routine tasks for palliative care patients and represent no significant
additional burden. In addition, the EORTC QLQ-C15-PAL questionnaire is the validated
short-form version of the EORTC QLQ-C30-PAL, whose design objective is reduced patient
burden. Furthermore, music therapy and these questionnaires are the standard of care in
palliative care. The investigators submit that risk category A is appropriate given these
methodological and ethical considerations.
