Effect of Music Intervention on Anxiety in Cancer Patients Undergoing Initial Radiation Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The physiological indicators - Blood pressure
研究概览
简要总结
This prospective randomized trial evaluated the effect of music interventions on anxiety and nervousness during 10 consecutive days in individuals undergoing their first radiation therapy session.
详细描述
A total of 100 participants were enrolled and randomly assigned to either the music group or nonmusic group (n = 50 each). Investigators ensured an equal distribution of men and women, without considering the cancer type. To minimize confounding factors and prevent shared learning experiences or communication between the two groups, the participants in the experimental and control groups were scheduled for treatment at different times throughout the year (from January 1, 2022 to December 31, 2022). Anxiety assessment questionnaires were administered before the treatment began and after 2 weeks of treatment. Physiological parameters, including heart rate, systolic and diastolic blood pressure, and blood oxygen levels, were monitored before and after 2 weeks of treatment. In the music intervention group, the patients received music intervention during RT for 10 consecutive days and listened to music for approximately 10-15 minutes in each session. The music period was then followed by a 10-day period without music during treatment to evaluate the differences in the same individuals. In contrast, the control group did not receive music intervention throughout their entire RT period. Investigators observed the music intervention group for 2 weeks to ascertain any differences.
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
- •patients undergoing RT for cancer for the first time
- •patients with clear consciousness and normal hearing
- •patients willing to respond to the questionnaire after the research process and purpose were explained to them.
排除标准
- •patients who had previously undergone RT
- •patients with diminished mental capacity or inability to satisfactorily participate in this study
- •patients with moderate to severe hearing impairment.
结局指标
主要结局
The physiological indicators - Blood pressure
时间窗: monitored before and after 2 weeks of treatment.
Blood pressure (mmHg) were measured by a PHILIPS M1205A noninvasive physiological monitor.
The physiological indicators - Blood oxygen
时间窗: monitored before and after 2 weeks of treatment.
Blood oxygen (oxygen saturation，SO2 %) were measured by a PHILIPS M1205A noninvasive physiological monitor.
The physiological indicators - Heart rate
时间窗: monitored before and after 2 weeks of treatment.
Heart rate (Beat per minute ) were measured by a PHILIPS M1205A noninvasive physiological monitor.
The anxiety status - Distress Thermometer
时间窗: monitored before and after 2 weeks of treatment.
Distress Thermometer (DT) which screens for psychological distress in patients with cancer as recommended by the National Comprehensive Cancer Network® (NCCN)
The anxiety status - Brief Symptom Rating Scale (BSRS-5)
时间窗: monitored before and after 2 weeks of treatment.
Brief Symptom Rating Scale (BSRS-5) or "Mood Thermometer," a 5-point Likert scale for assessing symptoms of emotional distress over 1 week. The total score ranges from 0 to 20.
The anxiety status - Beck Anxiety Inventory (BAI-C)
时间窗: monitored before and after 2 weeks of treatment.
Beck Anxiety Inventory (BAI-C, a 21-item self-reported questionnaire to assess anxiety symptoms on a 4-point scale, which has shown excellent internal consistency and test-retest reliability).
The anxiety status - Symptom Distress Thermometer (SDT)
时间窗: monitored before and after 2 weeks of treatment.
Symptom Distress Thermometer (SDT), a 10-point scale by the NCCN to evaluate distress levels.
次要结局
未报告次要终点