Trial Title:
Differences in Acceptability of Music Therapy Sessions Played Live Compared to a Recording Thereof
NCT ID:
NCT06108375
Condition:
Terminal Illness
Terminal Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
monocentric study utilizing a prospective repeated measures design
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
music therapy
Description:
music played live by a music therapist
Arm group label:
Live then recording
Arm group label:
Recording then live
Intervention type:
Other
Intervention name:
recording
Description:
a recording of the same music played by the music therapist
Arm group label:
Live then recording
Arm group label:
Recording then live
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
• Inability to answer a questionnaire due to physical limitations as well as cognitive or
linguistic reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Zurich
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
David Blum, Prof.Dr.med.
Phone:
+41 43 253 37 42
Email:
david.blum@usz.ch
Start date:
October 24, 2023
Completion date:
October 2024
Lead sponsor:
Agency:
University of Zurich
Agency class:
Other
Source:
University of Zurich
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06108375
