The Effectiveness of Music Therapy on Fatigue and Laboratory Values in Acute Leukemia Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Severe hearing impairment.
- •Individuals with unstable vital signs or altered consciousness.
结局指标
主要结局
Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21.
时间窗: 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).
次要结局
- Change from baseline in neutrophil, hemoglobin, abumin at day 21.(Baseline and Day 21.)
研究者
Chien-Yu Wu
Nurse
Chang Gung University