JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06108375

Studienbeginn:
Oktober 2023

Letztes Update:
01.12.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Zurich

Collaborator:
-

Studienleiter

David Blum, Prof.Dr.med.
Principal Investigator
University of Zurich

Kontakt

David Blum, Prof.Dr.med.
Kontakt:
Phone: +41 43 253 37 42
E-Mail: david.blum@usz.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Zurich
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
David Blum, Prof.Dr.med.
Phone: +41 43 253 37 42
E-Mail: david.blum@usz.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. intervention-specific acceptability questionnaire based on Theoretical Framework of Acceptability (Time Frame - immediately before and after the intervention):
assesses intervention acceptability, values 8 - 40, higher = better outcome

Secondary outcome:

1. Edmonton Symptom Assessment System (Time Frame - immediately before and after the intervention):
Assesses subjective symptom severity, values 0 - 120, higher = worse outcome

2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 15 Palliative Care (Time Frame - immediately before and after the intervention):
Assesses subjective quality of life, values 15 - 63, higher = worse outcome

3. Hospital Anxiety and Depression Scale (Time Frame - immediately before and after the intervention):
Assesses subjective anxiety and depression, values 0 - 42, higher = worse outcome

4. Qualitative open questions for patients (Time Frame - immediately before and after the intervention):
Assesses subjective experience of the intervention

5. Heart rate (Time Frame - immediately before and after the intervention):
Heart rate (bpm) is a basic marker of autonomic response and can reflect mortality and disease

6. Heart rate variability (Time Frame - immediately before and after the intervention):
Heart rate variability reflects neuro cardiac regulatory capacity and is a strong prognostic marker of mortality and disease

7. Electrodermal activity (μS; skin conductance response) (Time Frame - immediately before and after the intervention):
Electrodermal activity is a reliable biomarker of arousal

8. Temperature (Time Frame - immediately before and after the intervention):
Thermoregulation is tightly controlled and reacts to vigilance state

Studien-Arme

Other: Live then recording
During the first visit music will be played live, during the second visit a recording will play.
Other: Recording then live
During the first visit a recording will play, during the second visit music will be played live.

Geprüfte Regime

music therapy:
music played live by a music therapist
recording:
a recording of the same music played by the music therapist

Quelle: ClinicalTrials.gov

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