Effects of Music Therapy in Controlling Symptoms in Patients With Acute Myeloblastic Leukemia and Undergoing Hematopoietic Stem Cell Transplantation: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in physical and psychological symptom burden
研究概览
简要总结
The goal of this clinical trial is to test passive music therapy in patients receiving induction chemotherapy for an acute myeloblastic leukemia or undergoing an hematopoietic stem cell transplantation. The main questions it aims to answer are:
- Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients?
Participants will be randomly assigned to the control and experimental group. Patients included in both groups will complete weekly mood and quality of life questionnaires. Those included in the experimental group will also complete daily symptom burden questionnaires before and after listening to a music therapy session.
Researchers will confirm if the experimental group improves their symptoms after the music therapy session and will compare both groups to see if there are differences in mood and quality of life.
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
- None
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
- •≥ 18 years old.
- •Patients receiving induction chemotherapy for a newly diagnosed acute myeloblastic leukemia (except for acute promyelocytic leukemia).
- •Patients undergoing autologous or allogeneic stem cell transplantation.
- •Being able to understand and read Spanish properly.
- •Basic computer skills.
排除标准
- •Moderate-severe hearing impairment (unilateral or bilateral).
- •Past history of psychiatric disorders.
- •Performance status: ECOG ≥ 3.
结局指标
主要结局
Change in physical and psychological symptom burden
时间窗: The ESAS global score is measured before and after the daily music therapy session (from date of randomization until the date of discharge, up to 8 weeks)
Edmonton Symptom Assessment System (ESAS) global score (0 to 110 points, higher scores mean higher symptom burden)
次要结局
- Anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS) score(Once a week (from date of randomization until the date of discharge, up to 8 weeks))
- Quality of life assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) score(Once a week (from date of randomization until the date of discharge, up to 8 weeks))