Music Therapy in Acute Leukemia Patients With Fatigue

January 15, 2026 updated by: Chien-Yu Wu, Chang Gung University

The Effectiveness of Music Therapy on Fatigue and Laboratory Values in Acute Leukemia Patients Undergoing Chemotherapy

The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The researchers will explain the study objectives and methods, obtain informed consent, and have participants sign the consent form before commencing the study. Participants are randomly assigned to Group A and Group B. Participants in Group A undergo 30 minutes of self-selected music playback every day in addition to receiving standard therapy, while participants in Group B only receive standard therapy. The entire study duration spans 21 days.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taoyuan District, Taiwan, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with acute myeloid leukemia by a clinical specialist.
  2. Patients undergoing chemotherapy for the first time.
  3. Aged 18 years or older, capable of communicating in Mandarin or Taiwanese.
  4. Normal hearing ability.
  5. No history of psychiatric disorders and clear consciousness.
  6. Participants with no prior involvement in any intervention studies related to fatigue management.
  7. Demonstrates understanding of the research objectives, willingly participates in the study, and completes the informed consent form.
  8. Willing to cooperate with study procedures throughout the research period.

Exclusion Criteria:

  1. Severe hearing impairment.
  2. Individuals with unstable vital signs or altered consciousness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy
Participants received self-selected music app playback for 30 minutes every day and standard therapy. The entire study duration spans 21 days.
Other: Music Therapy
30 minutes of self-selected music playback every day.
No Intervention: Standard Care
Participants only received standard care during the entire study duration span of 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Score on the Tang Fatigue Rating Scale (TFRS) .
Time Frame: Day 21.
The TFRS is a validated, self-reported instrument assessing average fatigue intensity. It comprises a total of 37 items, with each item rated on a scale of 1 to 10. The total score is calculated by summing all 37 items, resulting in a range of 37 to 370. Higher scores indicate a greater level of fatigue intensity.
Day 21.
11-point Numeric Rating Scale (NRS-11).
Time Frame: Day 21.
The NRS-11 is validated, self-reported instrument assessing average fatigue intensity. NRS-11 scores range from 0 (no fatigue) to 10 (worst possible fatigue).
Day 21.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Neutrophil Count (ANC) at Day 21.
Time Frame: Day 21.
Absolute neutrophil count (ANC) was assessed through blood samples collected on the 21st day.
Day 21.
Hemoglobin Level at Day 21.
Time Frame: Day 21.
Hemoglobin levels were assessed through blood samples collected on the 21st day.
Day 21.
Albumin Level at Day 21.
Time Frame: Day 21.
Albumin levels were assessed through blood samples collected on the 21st day.
Day 21.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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