Preoperative Guided Imagery in Patients Undergoing Urologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery
研究概览
简要总结
This is a prospective randomized controlled trial of patients undergoing major urologic-oncologic surgery at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center. This clinical trial examines the effect of guided meditation before surgery on the levels of anxiety, stress, sleep disturbance, and quality of life among patients scheduled to undergo a major urologic surgery for cancer. A cancer diagnosis and the treatments associated with it can be very stressful for patients, leading to depression, sleep disturbances, and lower quality of life. Mind-body practices such as guided meditation have been used for thousands of years to reduce the effects of chronic stress and to improve quality of life. This clinical trial examines the effects of guided meditation on the stress, depression, and quality of life levels of patients undergoing urologic surgery for their cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the effect of 14 days of preoperative guided visualization meditation on patients' anxiety undergoing major urologic-oncology surgery.
SECONDARY OBJECTIVES:
I. To determine the effect of preoperative guided visualization meditation on patients' depression, stress, and quality of life.
II. To examine the difference in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey question scores between the two study groups.
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
- •Greater than or equal to 18 years of age.
- •Patients undergoing radical cystectomy, radical or partial nephrectomy, or radical prostatectomy at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center
- •Access to an electronic device that can play mp3 recording and for survey completion
- •At least a 2 week window from date of surgical booking to the scheduled surgery
排除标准
- •Inability to consent for the study (ie, they have a surrogate decision maker).
- •Non-English speaker (the meditations are only available in English)
- •Patients scheduled for surgery less than 2 weeks away
结局指标
主要结局
Change in scores on the State-Trait Anxiety Inventory (STAI) from baseline to day before surgery
时间窗: Up to 4 weeks
The Spielberger et. al STAI is a commonly used measure of trait and state anxiety . It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It has 20 items for assessing trait anxiety and 20 for state anxiety for a total of 40 items. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered Higher scores indicate greater anxiety. A two sample t-test will be used to compare the change between anxiety scores from baseline to the time point the day before surgery for the population as a whole and then adjusted for by surgery type.
次要结局
- Change in scores on the State-Trait Anxiety Inventory (STAI) over time(Up to 6 months)
- Change in scores on the EORTC-QLQ-C30 - Symptoms over time(Up to 6 months)
- Change in scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for cancer patients (EORTC-QLQ-C30) - Functional Domains over time(Up to 6 months)
- Rates of hospital re-admission rates at 4 weeks post operatively(4 weeks)
- Change in scores on the Center for Epidemiologic Depression Scale (CESD) over time(Up to 6 months)
- Change in scores on the Perceived Stress Scale (PSS) over time(Up to 6 months)
- Change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer over time(Up to 6 months)
- Percentage of emergency department (ED) visits at 4 weeks post-operative(4 weeks)
- Change in scores on the EORTC-QLQ-C30 Global Health Status over time(Up to 6 months)
- Mean scores on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey(Up to 6 months)
- Proportion of participants who completed daily meditation(Up to 6 months)