Trial Outcomes & Findings for Music Therapy in Acute Leukemia Patients With Fatigue (NCT NCT06286332)
NCT ID: NCT06286332
Last Updated: 2026-01-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Day 21.
Results posted on
2026-01-20
Participant Flow
Participants with acute myeloid leukemia were recruited from the hematology-oncology ward of a medical center in northern Taiwan.
Participant milestones
| Measure |
Experimental: Music Intervention Group
Participants received standard care plus music intervention for 21 days. The music intervention was provided for 30 minutes daily.
|
Control: Standard Care Group
Participants received standard care only.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Experimental: Music Intervention Group
Participants received standard care plus music intervention for 21 days. The music intervention was provided for 30 minutes daily.
|
Control: Standard Care Group
Participants received standard care only.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Transfer to ICU
|
2
|
0
|
Baseline Characteristics
Baseline characteristics are reported for participants who completed the study and were included in the final analysis.
Baseline characteristics by cohort
| Measure |
Experimental: Music Intervention Group
n=27 Participants
Participants received standard care plus music intervention for 21 days. The music intervention was provided for 30 minutes daily.
|
Control: Standard Care Group
n=28 Participants
Participants received standard care only.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.74 years
STANDARD_DEVIATION 14.04 • n=27 Participants • Baseline characteristics are reported for participants who completed the study and were included in the final analysis.
|
56.43 years
STANDARD_DEVIATION 14.60 • n=28 Participants • Baseline characteristics are reported for participants who completed the study and were included in the final analysis.
|
54.62 years
STANDARD_DEVIATION 14.31 • n=55 Participants • Baseline characteristics are reported for participants who completed the study and were included in the final analysis.
|
|
Sex: Female, Male
Female
|
13 Participants
n=27 Participants
|
11 Participants
n=28 Participants
|
24 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=27 Participants
|
17 Participants
n=28 Participants
|
31 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Tang Fatigue Rating Scale (Baseline)
|
135.63 scores on a scale
STANDARD_DEVIATION 44.79 • n=27 Participants
|
137.43 scores on a scale
STANDARD_DEVIATION 48.23 • n=28 Participants
|
136.55 scores on a scale
STANDARD_DEVIATION 46.15 • n=55 Participants
|
|
NRS-11 scores (Baseline)
|
5.59 scores on a scale
STANDARD_DEVIATION 0.36 • n=27 Participants
|
5.40 scores on a scale
STANDARD_DEVIATION 0.30 • n=28 Participants
|
5.49 scores on a scale
STANDARD_DEVIATION 0.34 • n=55 Participants
|
|
Absolute neutrophil count (ANC)
|
2678.97 cells/µL
STANDARD_DEVIATION 559.50 • n=27 Participants
|
2210.91 cells/µL
STANDARD_DEVIATION 568.45 • n=28 Participants
|
2453.94 cells/µL
STANDARD_DEVIATION 396.29 • n=55 Participants
|
|
Hemoglobin
|
8.91 g/dL
STANDARD_DEVIATION 1.38 • n=27 Participants
|
8.8 g/dL
STANDARD_DEVIATION 2.03 • n=28 Participants
|
8.86 g/dL
STANDARD_DEVIATION 1.7 • n=55 Participants
|
|
Albumin
|
3.55 g/dL
STANDARD_DEVIATION 0.47 • n=27 Participants
|
3.51 g/dL
STANDARD_DEVIATION 0.5 • n=28 Participants
|
3.53 g/dL
STANDARD_DEVIATION 0.48 • n=55 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Music Intervention Group
n=27 Participants
Participants received standard care plus music intervention for 21 days.
|
Control: Standard Care Group
n=28 Participants
Participants received standard care only.
|
|---|---|---|
|
Fatigue Score on the Tang Fatigue Rating Scale (TFRS) .
|
106.96 scores
Standard Deviation 37.92
|
128.46 scores
Standard Deviation 26.32
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Experimental: Music Intervention Group
n=27 Participants
Participants received standard care plus music intervention for 21 days.
|
Control: Standard Care Group
n=28 Participants
Participants received standard care only.
|
|---|---|---|
|
11-point Numeric Rating Scale (NRS-11).
|
4.07 scores on a scale
Standard Deviation 0.38
|
5.00 scores on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Day 21.Absolute neutrophil count (ANC) was assessed through blood samples collected on the 21st day.
Outcome measures
| Measure |
Experimental: Music Intervention Group
n=27 Participants
Participants received standard care plus music intervention for 21 days.
|
Control: Standard Care Group
n=28 Participants
Participants received standard care only.
|
|---|---|---|
|
Absolute Neutrophil Count (ANC) at Day 21.
|
2456.32 cells/µL
Standard Deviation 648.11
|
1373.60 cells/µL
Standard Deviation 657.88
|
SECONDARY outcome
Timeframe: Day 21.Hemoglobin levels were assessed through blood samples collected on the 21st day.
Outcome measures
| Measure |
Experimental: Music Intervention Group
n=27 Participants
Participants received standard care plus music intervention for 21 days.
|
Control: Standard Care Group
n=28 Participants
Participants received standard care only.
|
|---|---|---|
|
Hemoglobin Level at Day 21.
|
9.30 g/dL
Standard Deviation 0.31
|
8.19 g/dL
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Day 21.Albumin levels were assessed through blood samples collected on the 21st day.
Outcome measures
| Measure |
Experimental: Music Intervention Group
n=27 Participants
Participants received standard care plus music intervention for 21 days.
|
Control: Standard Care Group
n=28 Participants
Participants received standard care only.
|
|---|---|---|
|
Albumin Level at Day 21.
|
3.87 g/dL
Standard Deviation 0.13
|
3.49 g/dL
Standard Deviation 0.14
|
Adverse Events
Experimental: Music Intervention Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Control: Standard Care Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental: Music Intervention Group
n=30 participants at risk
Participants received standard care plus music intervention for 21 days.
|
Control: Standard Care Group
n=30 participants at risk
Participants received standard care only.
|
|---|---|---|
|
Infections and infestations
Septic shock
|
6.7%
2/30 • Number of events 2 • From enrollment through study completion (Day 21).
|
0.00%
0/30 • From enrollment through study completion (Day 21).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
3.3%
1/30 • Number of events 1 • From enrollment through study completion (Day 21).
|
6.7%
2/30 • Number of events 2 • From enrollment through study completion (Day 21).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place