Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
Narrative medicine addresses the therapeutic benefits that derive from patients forming and telling their personal stories. It offers an innovative model for improving health outcomes. When a patient with cancer and marked suffering writes a narrative of what he or she is going through, this process may reduce pain and improve quality of life.
Therefore, we seek to evaluate the effectiveness of writing a narrative on pain intensity and health related quality of life.
We propose a randomized single blind (evaluator) controlled trial. Patients with cancer pain of intensity at least 5/10 with a minimum Karnofsky score of 50% will be randomized into three groups: 1. Narrative group. Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks; 2. Writing-control group. Patients will fill a pain diary once a week for three weeks; 3. Control group. Subjects will not write/fill anything. Pain will be evaluated using the numerical scale before randomization and then weekly for 8 weeks. We will also evaluate how pain interferes with general activity, mood, work, relation with others, sleep, and enjoyment of life using the Brief Pain Inventory. As secondary outcomes, we will evaluate health related quality of life, with the treatment outcomes of pain survey, which is a modification of the SF 36 (short form health survey), and a global measure of well-being before randomization, and then at 4 and 8 weeks. We will also evaluate the emotional disclosure of the narratives.
We will use an intention to treat analysis. To analyze the effect of the treatment on pain intensity, quality of life, and well-being, we will employ an analysis of repeated measures using generalized estimating equations. We will include in the regression models the treatment group, the emotional disclosure score, the time, and the interaction between treatment group and time.
详细描述
Background and Significance: To our knowledge there are no randomized controlled trials (RCTs) that evaluate the benefits of narrative medicine, but there has been research on the effect of writing about traumatic events on health outcomes which resembles writing a narrative. However, the populations included have been almost exclusively young healthy students or workers, and the majority of studies have been performed by the same research group.
Study Population: We will recruit patients with cancer who report a pain intensity of at least 5/10. We will include patients who are still able to read and write. To evaluate this physical ability, we will use the Karnofsky scale. The minimum score a patient needs to have will be 50%.
Study Design: This is a randomized single blind (evaluator) controlled trial. Patients will sign an informed consent. Patients will be randomized into three groups.
1. Narrative group. Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks; 2. Writing-control group. Patients will fill a pain diary (requiring approximately 20 minutes) once a week for three weeks; 3. Control group. Subjects will not write/fill out anything.
Patients in the narrative group will be asked to write about their illness and how it has affected their lives. We will not guide the narrative in any other way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer pain of intensity at least 5/10 with a minimum Karnofsky score of 50%
排除标准
- •Patients unable to write or read
结局指标
主要结局
Pain intensity
次要结局
- Pain interference with general activity, mood, work, relation with others, sleep, and enjoyment of life.
- Health related quality of life