A Randomized Clinical Trial on the Effect of Guided Imagery and Progressive Muscle Relaxation for the Management of Pain, Stress, Anxiety and Depression as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Stress
研究概览
简要总结
The purpose of this study is to determine whether Guided Imagery and Progressive Muscle Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety and depression in patients with either prostate or breast cancer.
This study includes a total of 200 patients with prostate and breast cancer randomly assigned to either a control or intervention group.
The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle progressively tensing and relaxing).
Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and quality of life. Additionally, saliva samples were collected prior and after the sessions as to assess saliva cortisol and saliva α-amylase.
The same measurements were received by the patients of the control group as to allow comparisons.
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of breast or prostate cancer
- •Must be able to follow instructions
- •Good cognitive ability
- •Willing to participate
排除标准
- •Use of cortisone
- •Xerostomia
- •oral mucositis
结局指标
主要结局
Stress
时间窗: 20 months
Saliva α-amylase and saliva cortisol
次要结局
- Depression(20 months)
- Nausea-vomit(20 months)
- Pain(20 months)
- Fatigue(20 months)
- Anxiety(20 months)
- Quality of Life(20 months)
研究者
Dr. Andreas Charalambous
Lecturer-Researcher
Cyprus University of Technology