Music Therapy in Acute Leukemia Patients With Fatigue

NCT06286332 | Completed Results

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Fatigue

Keywords

AML; Music; Fatigue

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• Absolute Neutrophil Count (ANC) at Day 21.

  Day 21.

• Hemoglobin Level at Day 21.

  Day 21.

• Albumin Level at Day 21.

  Day 21.

Study Arms (2)

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.

Other: Music Therapy

Standard Care

NO INTERVENTION

Participants only received standard care during the entire study duration span of 21 days.

Interventions

Music Therapy OTHER

30 minutes of self-selected music playback every day.

Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan, 333, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 33538338 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.

  PMID: 33500864 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.

  PMID: 11839378 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.

  PMID: 34403772 BACKGROUND

• 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.

  PMID: 35689676 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.

  PMID: 17891547 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.

  PMID: 14669295 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.

  PMID: 31038430 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.

  PMID: 34077243 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.

  PMID: 28533058 RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Fatigue

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Principal Investigator
• Organization: Chang Gung University

k.kathleenwu@gmail.com

0905126618

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: April 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2025
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2026-01

Locations

TW (1)