Using Music As a Tool for Distress Reduction During Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Changes in pain assessed by Visual Analogue Scale
研究概览
简要总结
This trial studies how well music works in reducing distress in participants with cancer during chemotherapy treatment. Music in participants receiving cancer treatment such as infusion treatment and caregiver may reduce pain, anxiety, and distress and improve participant's psychological and physiological wellbeing.
详细描述
PRIMARY OBJECTIVES:
I. To test the effect of patients? listening to music on level of distress during cancer treatment.
SECONDARY OBJECTIVES:
I. To explore the influence of covariates (patients? sociodemographics, musical background, and clinical variables) on the association between patients? listening to music and level of distress during cancer treatment.
II. To explore the interdependence of adjustment among patients and their caregivers on the association between.
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
- •Able to speak, read, write and understand English
- •Have sufficient hearing capacity to hear music
排除标准
- •Patients with cognitive or perceptual disturbances will be excluded
结局指标
主要结局
Changes in pain assessed by Visual Analogue Scale
时间窗: 1 hour
Clinical variables will be summarized by median and range for continuous variables and by count and percentage for categorical variables. The changes between pre- and post-survey will be compared between control and experimental groups using an unpaired t-test. Total scores are reported with the total scores ranging from 0-10; higher scores indicate more pain.
Changes in mood assessed by Positive and Negative Affect Scale
时间窗: 1 hour
Clinical variables will be summarized by median and range for continuous variables and by count and percentage for categorical variables. The changes between pre- and post-survey will be compared between control and experimental groups using an unpaired t-test. There are two subscales: Positive Affect and Negative Affect. Scores for each subscale (10 items each) range from 10 to 50 with higher scores meaning higher levels of affect (either higher positive or higher negative affect).
Changes in distress assessed by Distress Thermometer.
时间窗: 1 hour
Clinical variables will be summarized by median and range for continuous variables and by count and percentage for categorical variables. The changes between pre- and post-survey will be compared between control and experimental groups using an unpaired t-test. Total scores are reported with the total scores ranging from 0-10; higher scores indicate more pain.
次要结局
未报告次要终点
研究者
Felicity Harper
Principal Investigator
Barbara Ann Karmanos Cancer Institute