Efficacy of music therapy on pain and anxiety symptoms in post-surgical cancer patients: A randomized controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To evaluate the change in pain & anxiety symptom severity (measured by change in VAS pain
研究概览
简要总结
Cancer, a chronic disease which is one of the leading causes of death. Cancer patients suffer from mental trauma like depression, anxiety, stress and pain during the disease and also after undergoing surgery. A non-invasive, inexpensive, easily accessible non-pharmacological intervention like Music can be quite effective in relieving these post-operative cancer patients of the depression, anxiety, stress and pain symptoms. Therefore, we aim to evaluate the change in pain, stress, depression and anxiety scores from baseline after 2 weeks treatment with music therapy plus treatment as usual (TAU) versus treatment as usual (TAU) in post-surgical cancer patients.
The study to be conducted for a period of two months after being approved from Institute’s Ethics Committee. It will be a prospective, randomized, open-label parallel design trial with a sample size of 44 divided into two groups i.e. Group A with sample size of 22 received music therapy along with the standard treatment regimen and a control group B (Treatment as usual) in which patients only received the standard treatment regimen. This study will involve use of tailor- made music tracks which will contain standardized music which have been proven to relieve patients suffering from depression, anxiety, stress and pain symptoms. Depression, Anxiety, Stress symptoms will be assessed using DASS 21 questionnaire and Pain symptoms will be analyzed using Visual Analogue Scale (VAS). The data obtained will be analyzed using the software IBM SPSS 22.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All cancer patients operated, stable and post-operative clinical care at surgical oncology ward Post-surgical cancer patients with age range between 18-65 Willing to give informed consent for the therapeutic intervention and to participate in the study.
排除标准
- •Any form of significant hearing and other sensory impairment Significant cognitive impairment Co-morbid diagnosed psychiatric condition Neurological disorder or significant medical condition impeding communication Uncooperative patients.
结局指标
主要结局
To evaluate the change in pain & anxiety symptom severity (measured by change in VAS pain
时间窗: Pain and anxiety symptoms severity to be assessed at baseline and at the time of discharge using the VAS pain score and DASS-21 questionnaire respectively
score, DASS-21 scores) from baseline after 2 weeks treatment with music therapy plus treatment as
时间窗: Pain and anxiety symptoms severity to be assessed at baseline and at the time of discharge using the VAS pain score and DASS-21 questionnaire respectively
usual (TAU) versus treatment as usual (TAU) in post-surgical cancer patients.
时间窗: Pain and anxiety symptoms severity to be assessed at baseline and at the time of discharge using the VAS pain score and DASS-21 questionnaire respectively
次要结局
- To evaluate the change in depression & stress symptom severity (measured by change in DASS-21 scores) from baseline after 2 weeks treatment with music therapy plus treatment as(usual (TAU) versus treatment as usual (TAU) in post-surgical cancer patients.)