Music Therapy in Acute Leukemia Patients With Fatigue

NCT ID: NCT06286332

Last Updated: 2026-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Music Therapy

Participants received self-selected music app playback for 30 minutes every day and standard therapy. The entire study duration spans 21 days.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type OTHER

30 minutes of self-selected music playback every day.

Standard Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Therapy

30 minutes of self-selected music playback every day.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

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Chien-Yu Wu

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 33500864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11839378 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34403772 (View on PubMed)

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.

Reference Type RESULT
PMID: 35689676 (View on PubMed)

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.

Reference Type RESULT
PMID: 17891547 (View on PubMed)

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.

Reference Type RESULT
PMID: 14669295 (View on PubMed)

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.

Reference Type RESULT
PMID: 31038430 (View on PubMed)

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.

Reference Type RESULT
PMID: 34077243 (View on PubMed)

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.

Reference Type RESULT
PMID: 28533058 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id

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