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Terminal IllnessNCT06108375

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

A study testing music therapy and recording in people with Terminal Illness and Terminal Cancer, run by University of Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Terminal Illness, Terminal Cancer
What is being tested?
music therapy and recording
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSwitzerland
Study dates
24 Oct 2023to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Blum, Prof.Dr.med. contact

0041 43 253 37 42

david.blum@usz.ch

Switzerland1 site, 1 recruiting
  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091

    David Blum, Prof.Dr.med., 0041 43 253 37 42, david.blum@usz.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
music therapy, recording

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • music therapyOther

    music played live by a music therapist

  • recordingOther

    a recording of the same music played by the music therapist

Study groups in NCT06108375
Study groupRoleWhat they receive
Live then recordingOtherDuring the first visit music will be played live, during the second visit a recording will play.
Receives: Other: music therapy; Other: recording
Recording then liveOtherDuring the first visit a recording will play, during the second visit music will be played live.
Receives: Other: music therapy; Other: recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intervention-specific acceptability questionnaire based on Theoretical Framework of Acceptability

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

    Measured: immediately before and after the intervention

Secondary outcomes (8)
  1. Edmonton Symptom Assessment System

    Assesses subjective symptom severity, values 0 - 120, higher = worse outcome

    Measured: immediately before and after the intervention

  2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 15 Palliative Care

    Assesses subjective quality of life, values 15 - 63, higher = worse outcome

    Measured: immediately before and after the intervention

  3. Hospital Anxiety and Depression Scale

    Assesses subjective anxiety and depression, values 0 - 42, higher = worse outcome

    Measured: immediately before and after the intervention

  4. Qualitative open questions for patients

    Assesses subjective experience of the intervention

    Measured: immediately before and after the intervention

  5. Heart rate

    Heart rate (bpm) is a basic marker of autonomic response and can reflect mortality and disease

    Measured: immediately before and after the intervention

  6. Heart rate variability

    Heart rate variability reflects neuro cardiac regulatory capacity and is a strong prognostic marker of mortality and disease

    Measured: immediately before and after the intervention

  7. Electrodermal activity (μS; skin conductance response)

    Electrodermal activity is a reliable biomarker of arousal

    Measured: immediately before and after the intervention

  8. Temperature

    Thermoregulation is tightly controlled and reacts to vigilance state

    Measured: immediately before and after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start24 Oct 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
monocentric study utilizing a prospective repeated measures design
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108375
Sponsor's protocol ID
MUSIC
Status last verified
Jul 2025
First submitted
19 Sep 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing music therapy and recording in people with Terminal Illness and Terminal Cancer, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Blum, Prof.Dr.med. (0041 43 253 37 42, david.blum@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intervention-specific acceptability questionnaire based on Theoretical Framework of Acceptability (time frame: immediately before and after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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