Efficacy of mindfulness based stress reduction on stress, anxiety, depression, quality of life and self-esteem of post-operative modified radical mastectomy breast cancer patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the efficacy of mindfulness based stress reduction (MBSR) on stress, anxiety, depression, quality of life and self-esteem of post-operative modified radical mastectomy breast cancer patients.
研究概览
简要总结
•Breast cancer patients who undergo modified radical mastectomy often experience severe psychological distress, including stress, anxiety, and depression, which can negatively impact their quality of life and self-esteem.While medical treatments improve physical recovery, the emotional and psychological challenges remain under-addressed.
•Mindfulness-Based Stress Reduction (MBSR) has shown potential in managing these issues by promoting emotional balance, reducing stress, and improving overall mental well-being.However, there is limited research on its effectiveness in Indian breast cancer patients.
•This study is can evaluate whether MBSR is an effective non-pharmacological intervention to improve the mental health and quality of life of post-operative breast cancer patients. It could also provide valuable insights for integrating MBSR into standard post-operative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women Patients in age group 18 – 70 years.
- •Patients willing to participate in the study after giving written informed consent.
- •Patients diagnosed with breast cancer and have undergone the process of modified radical mastectomy and are on the follow up.
- •Patients who have scored “8 & above” in the category of stress, “4 & above” in anxiety and “5 & above” in depression according to the scale DASS – 21, will be involved in the study.
- •Patients with the diagnoses of breast cancer Stage 1 – Stage 3 and undergone MRM.
排除标准
- •Patients with pre–existing psychiatric disorders and substance abuse disorder.
- •Patients who have chronic medical condition and have undergone surgical procedures other than Modified Radical Mastectomy for Breast cancer.
- •Patients with Stage IV breast cancer and metastatic cancer.
- •Women who have undergone Breast Conservation Surgery.
- •Patients who are not stable enough to communicate or participate in MBSR training program.
结局指标
主要结局
To assess the efficacy of mindfulness based stress reduction (MBSR) on stress, anxiety, depression, quality of life and self-esteem of post-operative modified radical mastectomy breast cancer patients.
时间窗: 4weeks - 8 weeks
次要结局
- Not applicable(Not applicable)
研究者
Bhavya Rastogi
Geetanjali Medical College and Hospital, Udaipur, Rajasthan