NCT06108375

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

September 19, 2023

Last Update Submit

July 7, 2025

Conditions

Terminal IllnessTerminal Cancer

Outcome Measures

Primary Outcomes (1)

  • intervention-specific acceptability questionnaire based on Theoretical Framework of Acceptability

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

    immediately before and after the intervention

Secondary Outcomes (8)

  • 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

  • Hospital Anxiety and Depression Scale

    immediately before and after the intervention

  • Qualitative open questions for patients

    immediately before and after the intervention

  • Heart rate

    immediately before and after the intervention

  • +3 more secondary outcomes

Study Arms (2)

Live then recording

OTHER

During the first visit music will be played live, during the second visit a recording will play.

Other: music therapyOther: recording

Recording then live

OTHER

During the first visit a recording will play, during the second visit music will be played live.

Other: music therapyOther: recording

Interventions

music therapyOTHER

music played live by a music therapist

Live then recordingRecording then live
recordingOTHER

a recording of the same music played by the music therapist

Live then recordingRecording then live

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • David Blum, Prof.Dr.med.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Blum, Prof.Dr.med.

CONTACT

0041 43 253 37 42david.blum@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: monocentric study utilizing a prospective repeated measures design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 31, 2023

Study Start

October 24, 2023

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)