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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy | Experimental | Participants received self-selected music app playback for 30 minutes every day and standard therapy. The entire study duration spans 21 days. |
|
| Standard Care | No Intervention | Participants only received standard care during the entire study duration span of 21 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Other | 30 minutes of self-selected music playback every day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Score on the Tang Fatigue Rating Scale (TFRS) . | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Neutrophil Count (ANC) at Day 21. | Absolute neutrophil count (ANC) was assessed through blood samples collected on the 21st day. | Day 21. |
| Hemoglobin Level at Day 21. | Hemoglobin levels were assessed through blood samples collected on the 21st day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 33500864 | Background | AlFayyad I, Al-Tannir M, Yaqub M, Heena H, AlMukaibil N, Ghazwani M, Abu-Shaheen A. Clinically Significant Fatigue in Adult Leukemia Patients: Prevalence, Predictors, and Impact on Quality of Life. Cureus. 2020 Dec 23;12(12):e12245. doi: 10.7759/cureus.12245. |
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Participants with acute myeloid leukemia were recruited from the hematology-oncology ward of a medical center in northern Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Music Intervention Group | Participants received standard care plus music intervention for 21 days. The music intervention was provided for 30 minutes daily. |
| FG001 | Control: Standard Care Group | Participants received standard care only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported for participants who completed the study and were included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Music Intervention Group | Participants received standard care plus music intervention for 21 days. The music intervention was provided for 30 minutes daily. |
| BG001 | Control: Standard Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics are reported for participants who completed the study and were included in the final analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue Score on the Tang Fatigue Rating Scale (TFRS) . | 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. | Posted | Mean | Standard Deviation | scores | Day 21. |
|
From enrollment through study completion (Day 21).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Music Intervention Group | Participants received standard care plus music intervention for 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Chang Gung University | 0905126618 | k.kathleenwu@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2025 | Nov 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Day 21. |
| Albumin Level at Day 21. | Albumin levels were assessed through blood samples collected on the 21st day. | Day 21. |
| 11839378 | Background | Schumacher A, Wewers D, Heinecke A, Sauerland C, Koch OM, van de Loo J, Buchner T, Berdel WE. Fatigue as an important aspect of quality of life in patients with acute myeloid leukemia. Leuk Res. 2002 Apr;26(4):355-62. doi: 10.1016/s0145-2126(01)00145-x. |
| 34403772 | Background | Rutkowski S, Czech O, Wrzeciono A, Kiper P, Szczepanska-Gieracha J, Malicka I. Virtual reality as a chemotherapy support in treatment of anxiety and fatigue in patients with cancer: A systematic review and meta-analysis and future research directions. Complement Ther Med. 2021 Sep;61:102767. doi: 10.1016/j.ctim.2021.102767. Epub 2021 Aug 14. |
| 35689676 | Result | Sezgin MG, Bektas H. The effect of music therapy interventions on fatigue in patients with hematological cancers: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2022 Nov;30(11):8733-8744. doi: 10.1007/s00520-022-07198-w. Epub 2022 Jun 11. |
| 17891547 | Result | Burns DS, Azzouz F, Sledge R, Rutledge C, Hincher K, Monahan PO, Cripe LD. Music imagery for adults with acute leukemia in protective environments: a feasibility study. Support Care Cancer. 2008 May;16(5):507-13. doi: 10.1007/s00520-007-0330-z. Epub 2007 Sep 22. |
| 14669295 | Result | Cassileth BR, Vickers AJ, Magill LA. Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. Cancer. 2003 Dec 15;98(12):2723-9. doi: 10.1002/cncr.11842. |
| 31038430 | Result | Reimnitz L, Silverman MJ. A randomized pilot study of music therapy in the form of patient-preferred live music on fatigue, energy and pain in hospitalized adult oncology patients on a blood and marrow transplant unit. Arts Health. 2020 Jun;12(2):154-168. doi: 10.1080/17533015.2018.1534251. Epub 2018 Oct 18. |
| 34077243 | Result | Miladinia M, Voss JG, Molavynejad S, Malehi AS, Zarea K, Nouri EM, Ahmadzadeh A. Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial. JCO Oncol Pract. 2021 Nov;17(11):e1614-e1621. doi: 10.1200/OP.21.00156. Epub 2021 Jun 2. |
| 28533058 | Result | Bates D, Bolwell B, Majhail NS, Rybicki L, Yurch M, Abounader D, Kohuth J, Jarancik S, Koniarczyk H, McLellan L, Dabney J, Lawrence C, Gallagher L, Kalaycio M, Sobecks R, Dean R, Hill B, Pohlman B, Hamilton BK, Gerds AT, Jagadeesh D, Liu HD. Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study. Biol Blood Marrow Transplant. 2017 Sep;23(9):1567-1572. doi: 10.1016/j.bbmt.2017.05.015. Epub 2017 May 19. |
Participants received standard care only.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Tang Fatigue Rating Scale (Baseline) | Mean | Standard Deviation | scores on a scale |
|
| NRS-11 scores (Baseline) | The NRS-11 is a validated, self-reported instrument assessing average fatigue intensity. Scores range from 0 (no fatigue) to 10 (worst possible fatigue). Higher scores indicate a greater level of fatigue. | Mean | Standard Deviation | scores on a scale |
|
| Absolute neutrophil count (ANC) | Mean | Standard Deviation | cells/µL |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Albumin | Mean | Standard Deviation | g/dL |
|
|
|
| Secondary | Absolute Neutrophil Count (ANC) at Day 21. | Absolute neutrophil count (ANC) was assessed through blood samples collected on the 21st day. | Posted | Mean | Standard Deviation | cells/µL | Day 21. |
|
|
|
| Secondary | Hemoglobin Level at Day 21. | Hemoglobin levels were assessed through blood samples collected on the 21st day. | Posted | Mean | Standard Deviation | g/dL | Day 21. |
|
|
|
| Secondary | Albumin Level at Day 21. | Albumin levels were assessed through blood samples collected on the 21st day. | Posted | Mean | Standard Deviation | g/dL | Day 21. |
|
|
|
| Primary | 11-point Numeric Rating Scale (NRS-11). | 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). | Posted | Mean | Standard Deviation | scores on a scale | Day 21. |
|
|
|
| 1 |
| 30 |
| 3 |
| 30 |
| 0 |
| 30 |
| EG001 | Control: Standard Care Group | Participants received standard care only. | 2 | 30 | 2 | 30 | 0 | 30 |
| Septic shock | Infections and infestations | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |