A Randomized Trial of Music to Decrease Anxiety in Women Starting Radiation Therapy for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
研究概览
简要总结
The primary hypothesis of the study is that listening to music will reduce anxiety in female cancer patients during the first radiotherapy treatment session.
详细描述
Receiving radiotherapy induces anxiety in at least 1/3 of patients who did not have a previously existing anxiety condition1. Female gender is a positive predictive factor for psychosocial decline during radiotherapy. One-fourth of patients disrupt their planned radiotherapy treatment course due to anxiety. Music therapy has demonstrated effectiveness in reducing anxiety when implemented in other medical settings including mechanical ventilation, burn debridement and venipuncture in pediatric patients. There have been some trials which have found a reduction in anxiety when pre-recorded music along with other relaxation techniques have been implemented during radiotherapy. This trial seeks to investigate the benefit of pre-recorded music alone in reducing anxiety experienced during the first radiotherapy treatment session in female cancer patients.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to receive radiotherapy for malignant tumor
- •ECOG Performance Status 0-4
- •Fluent in English Language
- •Inclusion in this study will not be based on race or ethnicity
- •Patients must be deemed able to comply with the treatment plan.
- •Patients must provide study specific informed consent prior to study entry.
排除标准
- •Prior history of radiation therapy
研究组 & 干预措施
Music
Patients randomized to the music intervention arm will select a preferred genre of music from an internet based resource.
干预措施: Music (Other)
No Music
These patient's will have no music playing during the first radiotherapy session.
结局指标
主要结局
Mean change of STAI Score from within 2 hours prior to first RT session to 2 hours post first RT session.
时间窗: baseline
Percent change in mean anxiety score as measured with the State-Trait Anxiety Inventory (STAI) questionnaire. Assessed by the mean value (pre minus post radiotherapy STAI score) divided by mean pre-treatment score multiplied by 100. A score of 39-40 on each subset suggests clinically significant anxiety.
次要结局
- Mean change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)
- Magnitude change of STAI Score(baseline)
- Magnitude change of SDT Score from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)
- STAI "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)
- SDT "High to Low Score" Change from within 2 hours prior to first RT session to 2 hours post first RT session.(baseline)