Clinical trial NCT06286332: Music Therapy in Acute Leukemia Patients With Fatigue
Official title: The Effectiveness of Music Therapy on Fatigue and Laboratory Values in Acute Leukemia Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Fatigue
Keywords: AML
Music
Fatigue
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21.
timeFrame: Baseline and Day 21.
Secondary outcomes:
measure: Change from baseline in neutrophil, hemoglobin, abumin at day 21.
timeFrame: Baseline and Day 21.
Other outcomes:
Locations:
Study officials:
References:
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