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Completed

NCT Number: NCT06286332

Music Therapy in Acute Leukemia Patients With Fatigue

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan, 333

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Music Therapy

Other

30 minutes of self-selected music playback every day.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. Hemoglobin Level at Day 21.

    Time frame: Day 21.

    Hemoglobin levels were assessed through blood samples collected on the 21st day.

  3. Albumin Level at Day 21.

    Time frame: Day 21.

    Albumin levels were assessed through blood samples collected on the 21st day.

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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