Acute Myeloid Leukemia, Fatigue
Conditions
Keywords
AML, Music, Fatigue
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.
Interventions
OTHERMusic Therapy
30 minutes of self-selected music playback every day.
Sponsors
Chang Gung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Score on the Tang Fatigue Rating Scale (TFRS) . | 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. |
| 11-point Numeric Rating Scale (NRS-11). | 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute Neutrophil Count (ANC) at Day 21. | Day 21. | Absolute neutrophil count (ANC) was assessed through blood samples collected on the 21st day. |
| Hemoglobin Level at Day 21. | Day 21. | Hemoglobin levels were assessed through blood samples collected on the 21st day. |
| Albumin Level at Day 21. | Day 21. | Albumin levels were assessed through blood samples collected on the 21st day. |
Countries
Taiwan
Participant flow
Recruitment details
Participants with acute myeloid leukemia were recruited from the hematology-oncology ward of a medical center in northern Taiwan.
Baseline characteristics
| Characteristic | — |
|---|---|
| Absolute neutrophil count (ANC) | 2210.91 cells/µL STANDARD_DEVIATION 568.45 |
| Age, Continuous | 52.74 years STANDARD_DEVIATION 14.04 |
| Albumin | 3.51 g/dL STANDARD_DEVIATION 0.5 |
| Hemoglobin | 8.8 g/dL STANDARD_DEVIATION 2.03 |
| NRS-11 scores (Baseline) | 5.49 scores on a scale STANDARD_DEVIATION 0.34 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
| Tang Fatigue Rating Scale (Baseline) | 135.63 scores on a scale STANDARD_DEVIATION 44.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 2 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 3 / 30 | 2 / 30 |
Outcome results
None listed