Music Therapy in Acute Leukemia Patients With Fatigue

Not Applicable

Not yet recruiting

• Conditions: Acute Myeloid Leukemia; Fatigue
• Interventions: Other: Music Therapy

• Registration Number: NCT06286332
• Lead Sponsor: Chang Gung University

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.

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21.	Baseline and Day 21.	The TFRS and NRS-11 is validated, self-reported instrument assessing average fatigue intensify.; The TFRS comprises a total of 37 items, encompassing 15 questions related to physiological aspects, 12 questions addressing psychosocial factors, and 10 questions focusing on daily living activities. The scoring system ranges from 1 to 10, with higher scores indicating a greater level of fatigue.; NRS-11 scores range from 0 (no fatigue) to 10 (worst possible fatigue). Change = (Day 21 score - Baseline score).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in neutrophil, hemoglobin, abumin at day 21.	Baseline and Day 21.	The alterations in hematologic parameters, specifically white blood cell count, hemoglobin levels, and albumin levels, were assessed through blood samples collected at baseline and on the 21st day.